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Chinese exports to south-east Asia are growing at almost twice the rate of the past four years, as Donald Trump’s trade war pushes Beijing to tighten trade links with its neighbours.
Chinese exports to the six largest economies in south-east Asia — Indonesia, Singapore, Thailand, the Philippines, Vietnam and Malaysia — rose 23.5 per cent from $330bn to $407bn in the first nine months of the year compared with the same period last year, according to official import data from those countries collated for the Financial Times by ISI Markets.
Chinese exports to those countries have doubled over the past five years, while China’s trade surplus with the region hit an all-time high this year. The 2025 increase is nearly twice as high as the 13 per cent compound annual growth rate in the previous four years.
China has long been criticised for “dumping” cheap goods in markets such as south-east Asia, threatening local producers with unfairly low prices but “the general China shock that has been going on for a few years has been amplified through US tariff deflection this year”, said Roland Rajah, lead economist at the Lowy Institute think-tank.
Economists say the latest wave of exports could be tied to attempts to circumvent US tariffs on Chinese-made products, which have been hit by levies of around 47 per cent. This compares with levies of about 19 per cent across many countries in south-east Asia.
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The US has warned against companies trying to mask the origin of Chinese-made products by rerouting them through other countries to avoid higher tariffs, saying such goods could be hit by “transshipment” levies of as much as 40 per cent. It is unclear how this has worked in practice.
In an upcoming paper, Rajah calculates Chinese exports to south-east Asia rose by as much as 30 per cent in September compared with a year earlier, noting that the most recent wave is different from earlier surges.
“While they are crowding out other exporters to the region, much of what they are exporting is actually pro-growth,” he said, adding that his research suggests as much as 60 per cent of Chinese exports this year were components for products manufactured in the region that were exported to other markets.
For consumer goods, China has increasingly become the dominant supplier to south-east Asia, taking market share from other countries.
“China’s supply glut, especially in cheap consumer goods, demands new outlets, and south-east Asia is the most natural spillover market given its proximity, logistics and scale,” said Doris Liew, an economist who formerly worked at Malaysia’s Institute for Democracy and Economic Affairs.
One area this has been most evident is in autos, with south-east Asian drivers switching in droves from Japanese models including the likes of Toyota, Honda and Nissan, to affordable electric cars made by China’s BYD.
The market share of Japan’s producers fell to 62 per cent of car sales in south-east Asia’s six biggest markets in the first half of 2025, down from an average of 77 per cent in the 2010s, according to PwC. China has increased its share from negligible volumes to more than 5 per cent of 3.3mn annual car sales in those markets.
In attempts to protect domestic manufacturers from being undercut by cheaper Chinese imports, some south-east Asian countries have tightened import rules and considered tariffs on certain goods.
But Liew said such actions were “piecemeal” and “stop-gap measures”. “The fundamental lesson is unavoidable: south-east Asian manufacturers must upgrade or be squeezed out,” she said. “China’s industrial ecosystem is far more innovative.”
Roula Khalaf, Editor of the FT, selects her favourite stories in this weekly newsletter.
Ben & Jerry’s co-founder Ben Cohen has clashed with the boss of Unilever’s ice cream spin-off after being told to “hand over to a new generation”, escalating a feud over the direction of the activist brand.
The row threatens to overshadow the demerger of the Magnum Ice Cream Company from its FTSE 100 parent as its shares start trading in Amsterdam on Monday.
Peter ter Kulve, Magnum’s chief executive, said that Cohen and Jerry Greenfield were in their seventies and “at a certain moment they need to hand over to a new generation”.
Their “commitment to the brand, to the causes, has been immense, but at a certain moment you need to hand it over . . . we need to move on”, he told the Financial Times in comments that also pertained to trustees of Ben & Jerry’s charitable arm, Jeff Furman and Liz Bankowski.
Cohen and Greenfield have become increasingly vocal about their dissatisfaction with the direction of the brand they launched almost 50 years ago and sold to Unilever for $326mn in 2000.
That deal put in place an independent board to protect the brand’s social mission and integrity. It also allowed Unilever to choose the chief executive, but only a minority of directors.
The co-founders have accused Unilever, and now Magnum — the ice cream business being spun off by the consumer goods giant — of impeding its activism. Greenfield quit Unilever in protest in September.
Cohen said: “Unlike Magnum, I don’t think there is an age limit on campaigning for social justice and peace. This is another attempt to silence the social mission that we are all too familiar with, as Unilever attempts to wash their hands of Ben & Jerry’s through this IPO. But Ben & Jerry’s social mission has always been inseparable from the brand itself, and it is legally protected.”
Greenfield, Furman and Bankowski did not respond to requests for comment.
Shares in the maker of Magnum, Carte D’Or, Cornetto and Solero will start trading on Monday in Amsterdam following the demerger from Unilever. Secondary listings in New York and London will take place later in the week.
Magnum will be the world’s largest ice cream company, with more than a fifth of the global market and annual revenues of €8bn. It is expected to perform better as a standalone company than as part of Unilever, which will retain a 19.9 per cent stake.
Magnum will inherit the campaigning Cohen, its most vocal employee, who has called on the parent to “free” the Chunky Monkey and Cookie Dough maker, and tried to raise funds to buy back Ben & Jerry’s.
Magnum also inherits a long-running legal spat with the Ben & Jerry’s board over its powers to define the company’s direction.
The board has accused Unilever of blocking its call for a ceasefire in Gaza, preventing it from supporting Palestinian refugees, and ousting David Stever as chief executive of Ben & Jerry’s earlier this year for failing to comply with Unilever’s attempts to silence the brand.
As the disputes drag on, Ter Kulve is cracking down on governance at the board and the brand’s charitable arm, the Ben & Jerry’s Foundation, which was funded by Unilever, and now Magnum.
Magnum said last month following an external investigation that Anuradha Mittal, chair of the brand’s independent board, “no longer meets the criteria” to serve but did not say why. People familiar with the matter said the investigation had uncovered conflicts of interest, again without disclosing what they were.
Counsel for the Ben & Jerry’s board said that Unilever’s “phantom allegations” were part of a campaign against Mittal due to her “efforts to protect the independence of Ben & Jerry’s under the merger agreement”.
The audit of the charity, meanwhile, uncovered “material deficiencies” in financial controls, governance and compliance, including conflicts of interest.
Ter Kulve said: “A significant amount of money, €5mn to €6mn a year goes to the foundation. I can’t continue to fund [the foundation] unless we basically have complied with the conclusions of the audit, and we’re working on that.”
Underlining his ambition for Ben & Jerry’s to break from the past, ter Kulve said he planned to expand the brand beyond its traditional tubs into sticks and ice cream sandwiches next year to capitalise on growing health awareness and consumer preference for smaller portion sizes.
“That was the big opportunity when you take a brand like Ben and Jerry’s . . . they were stuck in the pint [tub] for a very long time.”
Unilever announced it would spin off its ice cream division last year as part of a plan to slim down the sprawling multinational through lay-offs and divestments. Ter Kulve has set a medium-term organic sales growth target of 3 per cent, which is considered ambitious by analysts.
Barclays forecast a potential share price range of €20.78 to €21.46, based on an estimated equity value of €10.2bn to €10.5bn.
Before meeting for this interview, Tom Pickett opened Headspace, the app best known for mindfulness, and did a “breathing exercise” to “reset [his] brain”.
Usually he uses it at night. “My mind latches on to something before I go to bed, then I just can’t get it out of my head and I end up having poor sleep,” he says.
Since taking over as chief executive of Headspace in August last year, moving from US food delivery company, DoorDash, the 57-year-old, who has no formal experience in mental healthcare, has had a lot to get his head around. Over Zoom from his home office in San Francisco, Pickett has the look of a tech executive, with neat hair and a three-quarter zip fleece. In the background is a small sign: “Get Sh*t Done”.
“The healthcare industry is definitely complex. Every time you think you understand everything, you find that there’s a lot of nuances. It’s a constant learning process.”
Describing US-based Headspace as healthcare is a departure from its origins as a meditation app created by former Buddhist monk Andy Puddicombe and marketing executive Richard Pierson in 2010. It served up short digital programmes to busy professionals, with large employers, including Google, among the first to offer it to staff.
Four years ago, Headspace merged with Ginger, a mental health app focused more on coaching therapy and psychiatry, in a deal that valued the combined companies at $3bn. This broadened the product range to include access to virtual therapists, advice and workshops on topics such as mood management and insomnia. Headspace’s founders left in 2022, although Puddicombe’s voice continues to guide many of its meditations.
Since then, the company has intensified its push from consumers to employers and private health plans. More than 5.8mn people have access to Headspace through staff benefits provided by more than 4,500 organisations worldwide. In the new year, a deal with health insurer Cigna, will make the app accessible to an additional 7mn members in the US, through 18,000 employers’ health plans.
Overstretched public services and worsening mental health have created a gap for businesses to step in. But cynics see the type of digital service offered by Headspace as a cheap way to burnish the wellness credentials of organisations with long-hour cultures.
“This is one of the biggest challenges of our time,” says Pickett. “You can’t listen to the news without somebody talking about mental health, and increasingly so for the younger generations.”
The old model of “sending people to a therapist, a one-on-one human interaction” seemed inefficient to Pickett, who previously worked at Google, primarily for YouTube, for a decade.
“It was quite surprising to me . . . that there really isn’t a technology play in this space . . . We need to embrace technology. And if the primary modality of mental health is talking, then conversational AI has to have a big [part] in terms of how we solve this.”
Getting this right is among Pickett’s most important responsibilities. There have already been allegations of a chatbot encouraging one teenager to take his own life, and others urging users to self-harm. Mustafa Suleyma, Microsoft’s head of AI, has warned of “AI psychosis”, describing those who believe the technology is a God or lover.
“People are using AI tools that weren’t built for mental health,” warns Pickett. “General-use chatbots [are] built to do a lot of things. And they’re amazing. But they were not designed to take somebody who maybe has an acute mental illness and support them through a difficult time.”
Last year Pickett scaled back Headspace’s full-time therapists, moving them to part-time and contractor roles, to cut costs. At about the same time he launched the chatbot Ebb, which on Monday is upgrading from text-only to voice. Pickett insists this service is not designed for serious mental health issues and the company still offers remote therapists. Chatbots help “everyday emotional regulation” with bouts of anxiety or sleeplessness. “That’s frankly what a large part of the population really needs . . . Something to talk to, to reflect, to help process their emotions.”
Pickett says the company has developed a safety system to identify high-risk language and escalate serious concerns for human clinician review. All messages are monitored for potential risks, including suicidal and homicidal ideation, self-harm, domestic violence, substance use, eating disorders and abuse of vulnerable populations. When the conversation takes a turn into this territory, Ebb directs the user to crisis care, and ends the conversation.
Research finds well-designed chatbots can help with mental health issues, and some users find it easier to open up to them. “There’s some really interesting things that are evolving around people’s openness to put things on the table with a conversational AI in a way that they might not have done with a human therapist,” says Pickett.
He is “bullish” on AI’s potential. But “we have to make sure we protect against the downside”. At stake is the company’s reputation. “We’ve got 15 years of a brand that we’ve built up, building user trust, and we really do not want to lose that.”
The wellbeing sector is fiercely competitive. Headspace has lower downloads and monthly average users than its larger rival, Calm, according to Sensor Tower, the market intelligence company. But new downloads for both have fallen. In the third quarter of this year, Sensor Tower says Headspace’s monthly average users were 12 per cent lower than a year earlier.
Headspace says the fall reflects a shift from direct subscriptions to employer and health plans. Pickett says that, despite economic uncertainty, employers are not pulling back from wellbeing benefits. “Mental health continues to be a top two or three issue for companies . . . I think most of them want a solution that’s more than . . . the ‘call up a phone number’ kind of model.”
He hopes more insurers will follow Cigna by adding Headspace to employer schemes. “Historically, the only thing health plans covered was clinical . . . With employers, you go 10,000, 50,000 100,000 at a time, but with health plans, you go millions at a time. Ultimately, that could become the biggest part of our business.”
As a private company, Headspace does not disclose detailed financial information. Pickett says last year it made “north of $200mn in revenue” and operates “ebitda profitable”.
Pickett gained an insight into mental health struggles at the start of his career, when he spent nine years in the navy as an F-18 pilot, including two deployments to the Gulf. Behind him is a model and a large photo of F-18 aircraft. “We were put in stressful situations — a bunch of 18-year-olds to largely 30-somethings, away from their families. Stress, anxiety, [and] later forms of depression were out there, and people were trying to figure out how to deal with that.” Then, the attitude was “suck it up”.
His time in the navy provided a “great learning opportunity for management”, he says.
That might have helped when he took over at Headspace, and oversaw job cuts. “There were still elements of the merger that we were cleaning up. Systems integration, two products that you’re pushing into one. There [were] some cultural differences.”
Employees, he realised, were drawn by “the mission” of improving mental health; it “really matters deeply to people who work there”.
That has led to some criticism on Glassdoor, the anonymous employer review site, that Headspace’s culture is more focused on numbers than on wellbeing. One former employee wrote: “It’s quite ironic that so much of their content centres around taking care of your mental health at work.”
Pickett says the company is now in “a much better place”. “I’m happy with the size . . . today [about 400 staff]. People are definitely pushed. We have a lot to do.”
An IPO might be a long-term goal but for now his focus is on building a “sustainable, healthy business”. “You want the flexibility to move and evolve and invest.”
A day in the life of Tom Pickett
6:45am Wake up and check my Oura smart ring stats — seven hours of actual sleep is the goal. I then grab a coffee for the road and head to our San Francisco office.
Morning This is my peak problem-solving and creative-thinking window, so I frontload the day with meetings and anything that requires sharp thinking and clear decision-making.
Lunch When I’m not travelling, I eat at the office and try to catch up with others, all while staying on top of emails and Slack messages.
Afternoon Some days are dedicated to strategy deep dives, others are all about product. I do “skip-level” meetings to keep a pulse on what is going on through the organisation, do customer calls and meet my direct reports.
Evening It’s very important to me to get home for family dinner. With four kids, three still at home, this is the time to connect as a family. Everyone’s at the table, sharing their day.
I’ll try to squeeze in a run or walk. The rest of the night is spent helping with homework while prepping for the next day’s meetings. We have a no TV rule during the week.
Before bed, I wind down with Headspace, shut down all screens, and give myself the best shot at hitting my seven-hour sleep target.
SAN FRANCISCO and SUZHOU, China, Dec. 6, 2025 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces that seven of its innovative products have been included in the updated 2025 National Reimbursement Drug List (NRDL). This list features a new indication of TYVYT® (sintilimab injection), and first-time inclusions of SYCUME® (teprotumumab N01 injection, a recombinant anti-IGF-1R antibody), Limertinib (EGFR TKI), Dupert® (fulzerasib, KRAS G12C inhibitor), DOVBLERON® (taletrectinib, ROS1 inhibitor), Retsevmo® (selpercatinib, RET inhibitor), and Jaypirca® (pirtobrutinib, BTK inhibitor). The updated NRDL will be officially effective from January 1, 2026.
Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: “We are pleased with the NRDL inclusion of our seven innovative therapies this year. These therapies cover key disease areas that pose substantial public health challenges in China—particularly oncology (including lung, liver, gastric, esophageal, gynecological cancers, and hematological malignancies) as well as cardiovascular and metabolic (CVM) diseases. Their inclusion will help broaden patients’ access to and enhance their affordability of these medications, ultimately benefiting more individuals and families across the country. As a company with the mission of ’empowering patients worldwide with affordable, high-quality biopharmaceuticals’, Innovent continues to invest in pioneering treatments across oncology, CVM, autoimmune and ophthalmology—areas of significant societal need. We remain committed to our patient-centered approach, leveraging our innovation and product capabilities to further improve drug affordability and accessibility, so that high-quality medicines can reach and benefit more patients and their families as soon as possible. We are proud to contribute to better care for our patients.”
TYVYT® (sintilimab injection)
TYVYT® (sintilimab injection) is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. In China, sintilimab has been approved for eight indications and two more NDAs are under review by the NMPA, including squamous non-small cell lung cancer (NSCLC), non-squamous NSCLC, liver cancer, gastric cancer, esophageal cancer, endometrial cancer and Hodgkin’s lymphoma[i].
In the updated NRDL, the eighth indication of TYVYT®(sintilimab injection) is newly included, in combination with fruquintinib for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation. This new indication addresses a critical gap in treatments available for advanced endometrial cancer patients with limited responses to traditional therapies.
SYCUME® (teprotumumab N01 injection)
SYCUME® (teprotumumab N01 injection) is a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody developed by Innovent. SYCUME® blocks the activation of IGF-1R signaling pathway, consequently improving clinical manifestations such as proptosis, inflammation and diplopia, thus enhancing quality of life in patients with thyroid eye disease (TED)[ii].
In the updated NRDL, SYCUME®(teprotumumab N01 injection) is newly listed for moderate-to-severe thyroid eye disease. SYCUME®(teprotumumab N01 injection) is China’s first approved IGF-1R antibody drug, and this groundbreaking non-invasive therapy redefines the standard of care and serves the unmet needs for thyroid eye disease over past 70 years in China. The NRDL inclusion will bring this world-class novel treatment option to Chinese patients with thyroid eye disease and significantly enhance patient accessibility and affordability.
Limertinib
Limertinib is a third-generation EGFR TKI in collaboration with ASK Pharm, and Innovent holds exclusive commercialization rights in Mainland China.[iii]
In the updated NRDL, limertinib is newly listed for: 1) the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC), who have previously experienced disease progression during or after treatment with EGFR TKI; and 2) the first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations. Limertinib incorporates a unique naphthylamine group structure, which endows it with enhanced lipophilicity. This property ensures effective drug penetrate across the blood-brain barrier (BBB), thereby significantly reducing the risk of disease progression—specifically, the risk of disease progression in patients with brain metastases and the risk of intracranial disease progression. The NRDL inclusion of limertinib will provide a more effective treatment option for NSCLC patients with EGFR mutations.
Dupert® (fulzerasib)
Dupert® (fulzerasib) is a novel KRAS G12C inhibitor in collaboration with GenFleet Therapeutics, and Innovent holds exclusive development and commercialization rights in Greater China.[iv]
In the updated NRDL, Dupert®(fulzerasib) is newly listed for the treatment of advanced NSCLC adult patients harboring KRAS G12C mutation who have received at least one systemic therapy. The NRDL inclusion of Dupert®(fulzerasib) will provide a novel targeted therapy benefiting NSCLC patients harboring KRAS G12C mutation.
DOVBLERON® (taletrectinib)
DOVBLERON® (taletrectinib) is a novel next-generation ROS1 TKI in collaboration with Nuvation Bio China, a Nuvation Bio (NYSE: NUVB) Company, and Innovent holds exclusive commercialization rights in Greater China.[v]
In the updated NRDL, DOVBLERON® (taletrectinib) is newly listed for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The NRDL inclusion of DOVBLERON® (taletrectinib) will provide a potentially best-in-class therapy benefiting patients with locally advanced ROS1-positive NSCLC.
Retsevmo® (selpercatinib)
Retsevmo® (selpercatinib) is a selective and potent rearranged during transfection (RET) kinase inhibitor developed by Eli Lilly and Company and solely commercialized in Mainland China by Innovent.[vi]
In the updated NRDL, Retsevmo® (selpercatinib) is newly listed for the treatment of: 1) adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, 2) adult and pediatric patients 12 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation who require systemic therapy, and 3) adult and pediatric patients 12 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion who require systemic therapy and who are radioactive iodine-refractory. Retsevmo® (selpercatinib) is the first RET inhibitor approved globally and its NRDL inclusion will bring an innovative therapy for NSCLC and thyroid cancer patients with a RET alteration.
Jaypirca® (pirtobrutinib)
Jaypirca® (pirtobrutinib) is a non-covalent (reversible) BTK inhibitor developed by Eli Lilly and Company and solely commercialized in Mainland China by Innovent. Jaypirca® (pirtobrutinib) is the first and only non-covalent (reversible) BTK inhibitor approved in the world.[vii]
In the updated NRDL, Jaypirca® is newly listed for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two types of systemic therapy, including a BTK inhibitor. Its NRDL inclusion will benefit heavily-treated MCL patients that previously received the treatment of a BTK inhibitor, addressing their unmet needs and further enhancing Jaypirca’s affordability for those patients.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 17 products in the market. It has 1 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Roche, Takeda, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.
Guided by the motto, “Start with Integrity, Succeed through Action” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statements:
Innovent does not recommend the use of any unapproved drug (s)/indication (s).
Ramucirumab（Cyramza）, Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company’s competitive environment and political, economic, legal and social conditions.
The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.
Treatment with fixed-duration epcoritamab-bysp (Epkinly) plus dose-attenuated rituximab (Rituxan) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-mini-CHOP) appeared to be well tolerated and elicited responses in elderly patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL), according to data from arm 8 of the phase 1/2 EPCORE NHL-2 trial (NCT04663347).1
The data, which were presented at the 2025 ASH Annual Meeting, showed that at a median follow-up of 33.4 months (range, 2.8-41.1), the overall response rate (ORR) in all patients (n = 28) was 93%, which was comprised of a complete response (CR) rate of 86% and a partial response (PR) rate of 7%. The median time to response was 1.4 months (range, 1.1-2.7) and the median time to CR was 1.6 months (range, 1.2-8.1).
At 2 years, 79% (95% CI, 57%-91%) of patients remained in response to treatment with the regimen, and 79% (95% CI, 57%-91%) remained in CR. Of the 22 patients who completed therapy, 20 experienced a CR at the end of treatment (91%). At a median follow-up of 22.6 months after the end of treatment, 90% of the 20 patients remained in CR. Moreover, the 2-year progression-free (PFS) and overall survival (OS) rates were 76% (95% CI, 54%-89%) and 82% (95% CI, 62%-92%), respectively. The median PFS and OS were not reached, irrespective of International Prognostic Index score.
Examining Top Takeaway from the EPCORE NHL-2 Study of Epcoritamab in DLBCL
Fixed-duration epcoritamab plus R-mini-CHOP induced deep, rapid, and durable responses in elderly, frail patients with newly diagnosed DLBCL, with an ORR of 93% and a CR rate of 86%.
High MRD negativity rates (95%) and strong 2-year PFS (76%) and OS (82%) rates suggest meaningful long-term benefit despite high-risk baseline features.
The regimen was generally tolerable, with mostly manageable CRS and infection-related toxicities, supporting its potential role for patients unable to receive full-dose R-CHOP.
Of the 21 patients evaluable for minimal residual disease (MRD), 20 (95%) were negative at the time of the data cutoff date of September 21, 2025. At the first assessment, which was done on day 1 of cycle 3, 80% (n = 16) of patients achieved MRD negativity. Of the 4 MRD-positive patients at this assessment, 3 converted to MRD negativity by the second assessment, which was done on day 1 of cycle 6; 2 patients experienced subsequent progressive disease. Notably, MRD negativity was observed across all patient subgroups, including bulky disease (89%) and those with an IPI score ranging from 3 to 5 (93%).
“We can conclude that in combination with dose-attenuated chemotherapy, [epcoritamab] may have a role in the treatment of patients with historically poor outcomes,” Chan Cheah, MD, of the Sir Charles Gairdner Hospital and the University of Western Australia, in Nedlands, Australia, said during a presentation of the data.
Why add epcoritamab to R-mini-CHOP?
Although R-mini-CHOP is the standard of care (SOC) for patients with newly diagnosed DLBCL who are not able to receive the full dose, outcomes with the regimen remain suboptimal, Cheah explained. “It’s clear that better options for these patients are required,” he added. Previously, the CD3xCD20 bispecific antibody epcoritamab was found to be efficacious when administered as a monotherapy or paired with SOC in those with newly diagnosed DLBCL.
For example, findings from the phase 2 EPCORE DLBCL-3 trial (NCT05660967 ) indicated that single-agent epcoritamab induced durable responses in patients with newly diagnosed large B-cell lymphoma and comorbidities.2 Other findings from EPCORE NHL-2 showed that the combination of epcoritamab and R-mini-CHOP elicited an ORR of 89% and a CR rate of 82% in elderly patients with newly diagnosed DLBCL who could not receive the full dose of R-CHOP.3 At the meeting, Cheah shared follow-up data from EPCORE NHL-2.1
What did EPCORE NHL-2 evaluate?
The open-label, phase 1b/2 trial enrolled patients with newly diagnosed DLBCL, which could have been DLBCL not otherwise specified, T-cell or histocyte-rich DLBCL, high-grade B-cell lymphoma, or grade 3B follicular lymphoma. Patients had an ECOG performance status ranging from 0 to 2 and could not be eligible to receive full-dose R-CHOP because they were 75 years of age or older or 65 years of age or older with a comorbidity.
Twenty-eight patients received a fixed duration of subcutaneous epcoritamab at a dose of 48 mg once weekly for cycles 1 and 2 and every 3 weeks for cycles 3 to 6 and intravenous R-mini-CHOP, which comprised 375 mg/m2 of rituximab, 400 mg/m2 of cyclophosphamide, 25 mg/m2 of doxorubicin, 1 mg/m2 of vincristine—all given every 3 weeks—and 100 mg/day of prednisone, given on days 1 to 5 of each cycle from cycles 1 to 6. Epcoritamab was then given at 48 mg every 4 weeks for cycles 7 to 8.
ORR by investigator assessment served as the primary end point of the trial. Secondary end points included CR rate, duration of response, duration of CR, PFS, OS, MRD negativity, and safety.
In terms of baseline characteristics, the median patient age was 81 years (range, 74-90). Patients were not eligible to receive a full dose of anthracycline because of age older than 75 years (96%), hypertension requiring treatment (54%), diabetes mellitus (11%), or history of myocardial infarction (4%). Moreover, 43% of patients had an IPI score of 4 to 5 at screening, 39% had a bulky tumor of 7 cm or larger, and the majority had elevated lactate dehydrogenase (64%).
What was the safety profile of epcoritamab in this population?
Cheah noted that most adverse effects (AEs) were mild to moderate in severity, and no new safety concerns associated with the addition of epcoritamab to R-mini-CHOP presented with longer follow-up. The most frequent grade 3 or higher treatment-emergent adverse effects (TEAEs) were neutropenia (43%), serious infections (32%), and anemia 14%). Most grade 3 or higher serious infections were reported within the first 6 cycles of treatment, when R-mini-CHOP was being coadministered.
The most common TEAE was cytokine release syndrome (CRS), which occurred in 61% of patients; this effect was grade 1 for 32% of patients and grade 2 for 29% of patients. Time to first onset of CRS occurred at a median of 16 days (range, 8-17). Patients were treated with either tocilizumab (Actemra; 29%) or corticosteroids (14%), leading to CRS resolution across all patients affected. The median time to resolution was 2 days (range, 1-7). CRS led to treatment discontinuation in 1 patient. Cheah noted that almost all (90%) CRS events occurred in cycle 1 of treatment.
Additional common TEAEs occurring in 20% or more patients were neutropenia, serious infections, anemia, constipation, fatigue, hypokalemia, and fall. No patients experienced immune effector cell–associated neurotoxicity syndrome (ICANS) or tumor lysis syndrome (TLS).
TEAEs led to discontinuation of epcoritamab in 3 patients (11%), including 1 fatal event, and discontinuation of R-mini-CHOP in 6 patients (21%).
What is the significance of the updated EPCORE NHL-2 data?
“Despite an older population of newly diagnosed diffuse large B-cell lymphoma, the outcomes observed in arm 8 of the EPCORE NHL-2 evaluating fixed-duration epcoritamab plus R-mini-CHOP are encouraging,” Cheah stated in a news release issued by Genmab.4 “These results, along with those from other arms of the trial, support the potential for combinations of epcoritamab with standard of care treatment across a range of disease settings and patient populations.”
References
Cheah C, Ďuraš J, Belada D, et al. Epcoritamab + R-mini-CHOP results in 2-year remissions and high MRD negativity rates in elderly patients with newly diagnosed DLBCL: Results from the EPCORE NHL-2 trial. Presented at: 2025 ASH Annual Meeting; December 6-9, 2025; Orlando, FL. Abstract 64.
Vitolo U, Duell J, Burgues JMB, et al. Fixed-duration epcoritamab monotherapy induces high response and MRD-negativity rates in elderly patients with newly diagnosed large B-cell lymphoma (LBCL) and comorbidities: Results from EPCORE DLBCL-3. Presented at: 2025 ASH Annual Meeting; December 6-9, 2025; Orlando, FL. Abstract 63.
Leslie LA, Cheah CY, Morschhauser F, et al. Fixed-duration epcoritamab + R-mini-CHOP in patients with previously untreated diffuse large B-cell lymphoma ineligible for full-dose R-CHOP: Updated results from arm 8 of the Epcore NHL-2 trial. Blood. 2024;144(suppl 1):3106. doi: 10.1182/blood-2024-199652
Genmab press release. Genmab announces data from multiple clinical trials showing treatment with fixed-duration epcoritamab led to remissions in first-line diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). News release. Genmab. December 6, 2025. Accessed December 6, 2025. https://ir.genmab.com/news-releases/news-release-details/genmab-announces-data-multiple-clinical-trials-showing-treatment
Federal Reserve Chair Jerome Powell is set to preside over the US central bank’s last monetary policy meeting of 2025 amid a divided board (JUSTIN SULLIVAN)
While the US Federal Reserve’s final interest rate meeting this year could see an unusual amount of division, financial markets view a third straight interest rate cut as nearly certain.
When the Fed last met in October, Chair Jerome Powell asserted that another rate cut in December was “not a foregone conclusion,” pointing to “strongly differing views” within the central bank.
Minutes from the Fed’s most recent meeting showed many officials expect a further uptick in underlying goods inflation as President Donald Trump’s tariffs bite.
But recent comments from leading Fed officials also reflected support for cutting again because of a weakening labor market, even though inflation is still above the Fed’s two percent target.
Next week’s outcome in the “deeply divided” Fed was “too close to call,” UniCredit said, also acknowledging that favorable comments from New York Fed bank chief John Williams towards a cut were a notable “intervention.”
“As one of the most senior members of the (Fed committee), it seems unlikely Williams would have said this without Powell’s prior approval,” UniCredit said.
Policymakers generally hold rates at a higher level to tamp down price increases, but a rapidly deteriorating jobs market could nudge them to slash rates further to boost the economy.
“Usually, as you get closer to a policy meeting, it becomes quite apparent and transparent what the Federal Open Market Committee is going to do,” said Nationwide Chief Economist Kathy Bostjancic, referring to the Fed’s rate-setting committee.
“This time is very different,” she told AFP late last month.
Financial markets rallied following Williams’ statement on November 21 that rates could go lower in the “near term.”
Futures markets currently show more than 87 percent odds that the Fed will cut rates to between 3.50 percent and 3.75 percent, according to CME FedWatch.
– Dearth of data –
The Fed moved into rate cutting mode this fall, with rate cuts both in September and October.
But a government shutdown from October 1 through November 12 sapped the central bank of most of the key data points for assessing whether inflation or employment is now the bigger priority.
The latest available government data showed the jobless rate crept up from 4.3 percent to 4.4 percent in September, even as hiring beat expectations.
While delayed publications on September’s economic conditions have trickled out, the US government has canceled full releases of October jobs and consumer inflation figures because the shutdown hit data collection.
Instead, available figures will be published with November’s reports, but only after the Fed’s upcoming rate meeting.
The US personal consumption expenditures price index rose to 2.8 percent on an annual basis in September, from 2.7 percent in August, according to delayed data released on Friday.
The “Fed faces a bit of a paradoxical situation,” said EY-Parthenon Chief Economist Gregory Daco. “The Fed says these decisions will be data-dependent, but there isn’t a lot of data to go on.”
Daco expects a “weak majority” to favor another interest rate cut, but believes there could be multiple dissents.
– Looking beyond Powell –
Besides Wednesday’s decision, the Fed will also release projections for its 2026 economic and monetary policy outlook.
Next year will already mark a period of significant change with the conclusion of Powell’s tenure as chair in May.
Trump, who has relentlessly criticized Powell for not cutting rates more aggressively, signaled this week that his chief economic adviser Kevin Hassett could succeed Powell.
Hassett has appeared to be in lockstep with Trump on key economic questions facing the Fed. But if appointed, Hassett could also face pressure from financial markets to buck the White House on interest rates if inflation worsens.
“The institutional constraints often end up leading appointees towards some level of political independence,” said Daco, noting decisions require a board majority.
Whomever Trump picks will need to be confirmed in the US Senate.
While UniCredit predicted “political interference will have a modest impact on Fed policy,” deeper consequences cannot be ruled out.
“We have not assumed Trump will get de-facto control of the Fed,” UniCredit said, adding that such an outcome is “a non-negligible risk.”
Wondering whether STAAR Surgical at around $25 a share is a bargain or a value trap? Let us unpack what the market is really pricing in and what the fundamentals say.
The stock is roughly flat over the last year at about 0.3% while still up 5.3% year to date, but those modest gains sit on top of a painful multi year slide of around 58% over three years and nearly 68% over five.
That kind of long term drawdown usually reflects shifting expectations around growth and competitive pressure in its niche of implantable lenses, as investors reassess how fast premium vision correction can scale. At the same time, renewed interest in specialized medical devices and structural demand for refractive surgery keeps STAAR on many watchlists, even without splashy headline catalysts.
On our high level checks, STAAR currently scores just 2 out of 6 for undervaluation, which suggests pockets of value but not a screaming deal on traditional metrics alone. Next, we will walk through the main valuation approaches that produce that score and outline a more insightful way to think about what the stock might really be worth by the end of this article.
STAAR Surgical scores just 2/6 on our valuation checks. See what other red flags we found in the full valuation breakdown.
A Discounted Cash Flow model estimates what a business is worth today by projecting its future cash flows and then discounting them back to the present using a required rate of return.
For STAAR Surgical, the latest twelve month Free Cash Flow is negative at about $42.7 Million, which reflects current investment and profitability challenges. Analysts project an improvement, with Free Cash Flow expected to reach $66 Million by 2029, and Simply Wall St then extrapolates further growth out to 2035 based on those analyst inputs.
When all projected cash flows are discounted back to today using a 2 Stage Free Cash Flow to Equity model, the intrinsic value comes out at around $37.33 per share. With the stock trading near $25, the DCF suggests the shares are roughly 32.0% undervalued and that the market may be skeptical that STAAR will fully deliver on these cash flow improvements.
Result: UNDERVALUED
Our Discounted Cash Flow (DCF) analysis suggests STAAR Surgical is undervalued by 32.0%. Track this in your watchlist or portfolio, or discover 911 more undervalued stocks based on cash flows.
STAA Discounted Cash Flow as at Dec 2025
Head to the Valuation section of our Company Report for more details on how we arrive at this Fair Value for STAAR Surgical.
For companies where earnings are volatile or negative, the Price to Sales ratio is often a cleaner way to think about valuation. It focuses on what investors are paying for each dollar of revenue rather than profit that can swing with short term spending decisions.
A higher or lower “normal” multiple tends to reflect how quickly a business can grow those sales and how risky that growth looks. Faster, more predictable growth usually aligns with a higher Price to Sales ratio, while slower or shakier growth is often closer to or below the market and industry averages.
STAAR Surgical currently trades on a Price to Sales ratio of about 5.47x, which is meaningfully above both the Medical Equipment industry average of roughly 3.37x and the peer average of around 3.37x. Simply Wall St’s Fair Ratio for STAAR is 3.79x, a proprietary estimate of the multiple the stock could trade on given its growth outlook, profitability, industry, size, and risk profile.
Because the Fair Ratio blends all of these fundamentals, it is a more nuanced benchmark than a simple peer or industry comparison. With STAAR’s current 5.47x sitting well above the 3.79x Fair Ratio, the stock screens as overvalued on this measure.
Result: OVERVALUED
NasdaqGM:STAA PS Ratio as at Dec 2025
PS ratios tell one story, but what if the real opportunity lies elsewhere? Discover 1450 companies where insiders are betting big on explosive growth.
Earlier we mentioned that there is an even better way to understand valuation, so let us introduce you to Narratives, a simple way to connect your view of a company with the numbers behind it. A Narrative is the story you believe about a business, expressed through assumptions about its future revenue, earnings and margins, which then flow through to a forecast and an estimated fair value. On Simply Wall St, Narratives are an easy, accessible tool on the Community page, where millions of investors can turn their perspective on a company into a structured financial view. By comparing your Narrative Fair Value to the current share price, you can quickly decide how STAAR Surgical aligns with your own investment view as a potential buy, hold or sell, and because Narratives update dynamically as new news, earnings or guidance comes in, your view remains current rather than static. For example, on STAAR Surgical today, one investor might see upside to a fair value around $28 on the back of a China recovery and new products, while another could take a more cautious stance closer to $16 if they doubt the rebound and worry more about competition and execution risk.
Do you think there’s more to the story for STAAR Surgical? Head over to our Community to see what others are saying!
NasdaqGM:STAA Community Fair Values as at Dec 2025
This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include STAA.
Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com
Berkshire Hathaway (BRK.B) quietly keeps doing what it does best, compounding value in the background while the market chases headlines. With the stock grinding higher this year, it is worth unpacking what is driving that steady climb.
See our latest analysis for Berkshire Hathaway.
At around $504.34 per B share, Berkshire’s steady 11.8 percent year to date share price return and five year total shareholder return of 122.77 percent suggest that long term momentum remains firmly intact, even if short term sentiment occasionally wobbles.
If Berkshire’s slow and steady climb appeals to you, it may be worth seeing what else is available by exploring fast growing stocks with high insider ownership.
With shares hovering near record highs yet still trading at a sizable discount to some intrinsic value estimates, investors face a familiar Berkshire dilemma: is this a fresh buying opportunity or is future growth already priced in?
On a last close of $504.34 per B share, Berkshire trades on a 16.1x price to earnings ratio, cheaper than many peers despite its scale and track record.
The price to earnings multiple compares what investors are paying today for each dollar of current earnings. This is a particularly relevant lens for a mature, diversified conglomerate like Berkshire Hathaway. With a five year earnings growth rate of 5.4 percent per year and high quality earnings, the current multiple suggests the market is not extrapolating especially aggressive profit growth from here.
Against direct peers, Berkshire looks attractively priced, with its 16.1x price to earnings ratio sitting well below the peer average of 25.3x. However, within the broader US diversified financials industry, the shares appear more fully valued. They are trading above the 13.6x industry average and only slightly below the estimated fair price to earnings ratio of 16.9x, a level the market could gravitate toward if sentiment or fundamentals shift.
Explore the SWS fair ratio for Berkshire Hathaway
Result: Price to Earnings of 16.1x (UNDERVALUED)
However, Berkshire is not risk free. Slowing earnings growth and a recent net income decline raise questions about how long its valuation gap can persist.
Find out about the key risks to this Berkshire Hathaway narrative.
While the 16.1x price to earnings ratio hints at sensible pricing, our DCF model tells a stronger story. With shares at $504.34 versus an estimated fair value of $768.37, Berkshire screens as materially undervalued, raising the question of whether the market is underestimating its long term cash generation.
Look into how the SWS DCF model arrives at its fair value.
BRK.B Discounted Cash Flow as at Dec 2025
Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Berkshire Hathaway for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 911 undervalued stocks based on their cash flows. If you save a screener we even alert you when new companies match – so you never miss a potential opportunity.
If you see things differently or want to dive into the numbers yourself and shape your own investment story in minutes, Do it your way.
A great starting point for your Berkshire Hathaway research is our analysis highlighting 1 key reward and 2 important warning signs that could impact your investment decision.
If Berkshire has your attention, do not stop there. Use the Simply Wall Street Screener to uncover more targeted opportunities that match your strategy.
This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include BRK-B.
Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com
The CD20 × CD3-directed bispecific antibody odronextamab produced high, potentially durable complete responses (CR) and had a generally manageable safety profile when administered in combination with standard CHOP chemotherapy to patients with previously untreated diffuse large B-cell lymphoma (DLBCL) and high-risk features, according to initial results from part 1 of the phase 3 OLYMPIA-3 study (NCT06091865).1
Data presented during the 2025 ASH Annual Meeting and Exposition showed that the objective response rate (ORR) with this rituximab (Rituxan)–free regimen was 78% with the weekly 80 mg dose of odronextamab plus CHOP and was 100% for the weekly 160 mg dose of odronextamab plus CHOP. The complete response rates were 44% and 100% for each dose, respectively. The median duration of response, duration of complete response, and progression-free survival were not yet reached at the early analysis. Based on the combination of efficacy and safety, the 160 mg dose of odronextamab was selected for further investigation in the randomized portion of the study comparing the bispecific with rituximab.
“Data from part 1a of OLYMPIA-3 suggest that when combining odronextamab with CHOP in previously untreated patients with DLBCL, rituximab was not required to achieve deep and durable responses,” lead investigator Jean-Marie Michot, MD, from Institute Gustave Roussy, said during a presentation of the results. “The safety profile of fixed duration odronextamab-CHOP treatment was generally manageable in patients with previously untreated DLBCL with high-risk features, with no new safety signals compared with previous reports.”
OLYMPIA-3 Study Design and Patient Characteristics
The open-label study was designed with 2 parts. In part 1, the dose of odronextamab was escalated and optimized. Standard CHOP was given on day 1 and 8 of each cycle and odronextamab was administered starting on day 8, initially at a step-up dose of 0.7/4/20 mg and then at varying dose levels including 80 mg or 160 mg weekly and 160 mg and 320 mg every 2 weeks, with data only available for the weekly doses. Part 2 of the study will continue CHOP with patients randomly assigned to receive odronextamab (Odro-CHOP) or rituximab (R-CHOP).
Across all of part 1, the median age of patients was 66 years (range, 24-81), with nearly a third aged 75 or older (32%). ECOG performance status was 0 (40%), 1 (45%), and 2 (14%). The primary cell of origin was non-GCB (59%), and all patients had de novo DLBCL. IPI score was 3 for 36% and 4 to 5 for 27% of patients. The Lugano stage was III to IV for 95% of patients.
At the time of the analysis, 77.8% of patients enrolled to the 80 mg dose had completed cycle 1 to 6 (7 of 9). The remainder of patients in this group had discontinued early, due to physician decision (n = 2). In the 160-mg arm (n = 13), all patients had completed cycle 1 and 84.6% had completed cycle 6. Two discontinued early due to physician decision. The relative dose intensity was 87% in the 80-mg group and 77% in the 160-mg group.
“Most patients completed 6 cycles of odronextamab-CHOP at both dose levels,” said Michot. “There were few dose reductions of odronextamab and no permanent treatment discontinuations due to TEAEs related to odronextamab. There were no clinically important differences in safety between dose levels.”
Additional Odronextamab Efficacy Findings
The median duration of follow-up was 9.2 months for those enrolled in the 80 mg dose and was 7.8 months for those in the 160 mg dose. At the assessment, most responses remained ongoing. “CRs appeared durable,” Michot said.
In a biomarker analysis, B cell counts declined quickly following the initiation of therapy. There was an initial drop with CHOP administration, with B cells being completely cleared with the initiation of odronextamab.
There was slight T cell margination following the initiation of therapy, but these were transient and like prior reports with odronextamab, Michot said. T cell findings were similar for each dose.
Odronextamab Safety Profile in OLYMPIA-3
Grade 3 or higher treatment emergent adverse events (TEAEs) were experienced by all patients treated with the 80 mg and 160 mg doses of odronextamab. Serious TEAEs were seen in 77.8% of those treated with the 80 mg dose and for 92.3% of those administered the 160 mg dose. TEAEs led to treatment interruption or delay for 66.7% of those in the 80-mg arm and for 84.6% of those in the 160-mg group.
TEAE led to an odronextamab dose reduction for no patients in the 80 mg-arm and for 1 in the 160-mg group. Dose results in CHOP due to TEAEs were needed for 1 patient in the 80-mg group and for 5 in the 160-mg group. TEAEs led to treatment discontinuation for 1 patient in each dose level arm. There was 1 TEAE that led to death in the 160-mg arm. “Of note, there were no dose-limiting toxicities reported,” Michot said.
Across both doses, the most common TEAE was neutropenia (81.8%), cytokine release syndrome (CRS; 54.5%), anemia (45.5%), and nausea (40.9%). The most common treatment-related adverse events were similar with neutropenia seen in 77.3% of patients, CRS in 54.5%, anemia in 45.5%, and nausea in 36.4%.
CRS was solely grade 1/2 in severity, with 40.9% of patients having a grade 1 event and 13.6% having a grade 2 event. Tocilizumab was administered to manage CRS for 27.3% of patients and steroids were given for 18.2%. The median CRS duration was 3.8 months and the median time to onset was 9 hours. CRS mostly occurred during the step-up dosing phase at the lowest dose of 0.7 mg, after this initial step-up the rates of CRS were low. There were no cases of immune effector cell–associated neurotoxicity syndrome or tumor lysis syndrome.
Infections were seen in 81.8% of patients treated across both levels. Of these, 31.8% were grade 3 in severity and 9.1% were grade 4. Opportunistic infections were experienced by 50% of patients, of which only 1 patient had a grade 3 or higher opportunistic infection. The most commonly reported events were CMV infection or reinfection (27% for both) or COVID-19 and oral candidiasis (18% for each).
Odronextamab Regulatory History and Further Study
In August of 2025, the FDA issued a complete response letter (CRL) for a biologics license application for odronextamab for the treatment of relapsed/refractory follicular lymphoma following 2 or more lines of systemic therapy.2 Additionally, in March of 2024,3 the agent received 2 CRLs for DLBCL and follicular lymphoma. In both cases, the applications were based on phase 2 findings. The CRL issued in August noted concerns with site inspections completed at a plant ran by Catalent Indiana LLC.
Odronextamab is the subject of several clinical trials across several disease settings, either as monotherapy or in various combination regimens, including the phase 3 OLYMPIA-2 study (NCT06097364) for follicular lymphoma and the phase 3 OLYMPIA-5 study (NCT06149286) looking at odronextamab plus lenalidomide for follicular lymphoma.
References
Michot J-M, Yagci M, Kargus K, et al. Odronextamab plus chemotherapy in patients with previously untreated diffuse large B-cell lymphoma (DLBCL): First Results from part 1 of the Phase 3 Olympia-3 study. Blood. 2025;146 (Supplement 1):abstract 65. doi:10.1182/blood-2025-65
Regeneron Reports Second Quarter 2025 Financial and Operating Results. News release. Regeneron. August 1, 2025. Accessed December 6, 2025. https://tinyurl.com/bdz4e7ex
Regeneron provides update on biologics license application for odronextamab. News release. Regeneron. March 25, 2024. Accessed December 6, 2025. https://tinyurl.com/mr2w4j8x
Treatment with the hepcidin mimetic rusfertide continued to demonstrate sustained hematocrit control below 45% and high rates of phlebotomy ineligibility through week 52 for patients with polycythemia vera (PV), according to updated findings from the phase 3 VERIFY study (NCT05210790) presented at the 2025 ASH Annual Meeting.1
For those who crossed over from placebo to rusfertide, there was a rapid and durable drop in their hematocrit levels within the first 4 weeks. Both groups had similar levels of hematocrit control by week 52, regardless of having received a placebo or rusfertide in the first part of the study. For those continuing rusfertide from part 1a of the study to part 1b, the response rate, defined as absence of phlebotomy eligibility, went from 76.9% to 84.1%. For those who switched from placebo in part 1a to rusfertide in part 1b, the response went from 32.9% to 77.9%.
“Rusfertide met the primary and all 4 secondary end points in VERIFY from baseline to week 32 and continued to provide durable, sustained control of hematocrit below 45% and phlebotomy ineligibility through week 52,” lead investigator Andrew Kuykendall, MD, at Moffitt Cancer Center in the Department of Malignant Hematology, said during a presentation of the results. “After 52 weeks of treatment in VERIFY, rusfertide was well tolerated with a safety profile that was consistent with prior observations.”
Updated VERIFY Data: Rusfertide in Polycythemia Vera
Rusfertide provided durable hematocrit control less than 45% and high phlebotomy ineligibility through 52 weeks in patients with polycythemia vera.
Patients switching from placebo experienced rapid, sustained hematocrit reduction and normalization of iron parameters without worsening systemic iron deficiency.
The treatment was well tolerated, with mostly mild-to-moderate adverse events, supporting ongoing long-term evaluation and planned regulatory submission.
What is the study design of VERIFY?
The phase 3 study was broken into several parts. In part 1a, patients were randomly selected to receive the current standard of care plus rusfertide (n = 147) or placebo (n = 146) for 32 weeks, with primary end points assessed at weeks 20 to 32. After this initial period, patients in the placebo group crossed over to receive rusfertide plus standard of care. This open-label part of the study (part 1b; n = 274) continued until week 52, at which point the durability of response was assessed. Standard of care was defined as phlebotomy with or without cytoreductive therapy. Subsequent parts of the study are ongoing to assess long-term safety. Results from ASH were for Part 1b.
Baseline characteristics were balanced between groups in part 1a of the study, Kuykendall noted. In part 1b, the median age was 57 years, and most patients were male (72.6%). Nearly half of patients had high-risk PV (44.9%), which was defined as having a prior thromboembolic event and/or age 60 or older. The median age at PV diagnosis was 51 years, and the median PV duration was 2.9 years.
Nearly half of patients were not on a cytoreductive therapy for part 1b of the study (44.9%), which was consistent with part 1a. For those on therapy, the most common was hydroxyurea (38.3%), followed by interferons (13.9%). There was a small subset of patients on ruxolitinib (2.6%; Jakafi).
What were the results from part 1a of the VERIFY study?
In part 1a of the study, rusfertide was superior to placebo across all key end points. For placebo and rusfertide, respectively, the response rates were more than doubled (32.9% vs 76.9%; P <.0001), and 62.6% of those on rusfertide had a hematocrit lower than 45% compared with 14.4% for placebo (P <.0001). There were fewer (P <.0001) mean phlebotomies required with rusfertide (n = 0.5) compared with placebo (n = 1.8).
In addition to clinical end points, patient-reported outcomes were also superior with rusfertide. For the PROMIS fatigue SF-8a T-score, there was a 0.17 increase at week 32 with placebo compared with a decline of 1.78 for rusfertide, suggesting less fatigue (-1.95 delta; P = .0268). Improvement was also seen in Myelofibrosis Symptom Assessment Form Version 4.0 Total Symptom Score 7 Items, with a 0.54 drop with placebo and a 2.40 drop for rusfertide (-1.87 delta; P = .0239).
What were the new rusfertide findings from part 1b of VERIFY?
The median time to phlebotomy was not reached in the rusfertide arm compared with 16 weeks in the placebo group for part 1a. In part 1b, the median time to phlebotomy was not estimable in both arms. “Once patients switched from placebo to rusfertide, time to first phlebotomy looked similar in both groups,” Kuykendall said.
Ferritin levels normalized over time for those receiving rusfertide, with a continued improvement seen with rusfertide throughout the course of the study. There was no change with placebo in part 1a but a consistent climb in ferritin once patients crossed over to received rusfertide. There was only a small change in serum iron levels in both groups of patients (from ~6 µm ol/L at baseline increasing to ~10 µm ol/L). Transferrin levels decreased with rusfertide while transferrin saturation increased. As with all levels, a significant shift could be seen with patients moved from placebo to rusfertide.
“Rusfertide lowered hematocrit levels without exacerbating systemic iron deficiency,” added Kuykendall.
There was a modest improvement in mean corpuscular volume levels with rusfertide. Leukocytes counts were stable in both arms with a slight increase, and an improvement in platelet counts was seen with rusfertide.
What was the safety profile for rusfertide in VERIFY?
At the data cutoff, 86.7% of patients continued to receive open-label rusfertide, with discontinuations being uncommon, Kuykendall said. In part 1a, just 7.5% of patients discontinued rusfertide due to adverse events (AEs; n = 8) or study withdrawal (n = 3). This compares with a discontinuation rate of 4.1% in the placebo group for AEs (n = 5) and disease progression (n = 1). In part 1b, the discontinuation rate was 2.6%, with 3 from AEs, 2 from lack of efficacy, 1 for other reasons, and 1 for study withdrawal.
In part 1a, there were fewer secondary cancer events in the rusfertide group compared with placebo (3 vs 8, respectively). In part 1b, those who switched from placebo had 2 cancer events compared with 4 in the arm that was on rusfertide for both part 1a and 1b.
Most AEs were grade 1 or 2 in severity, with at least 1 treatment-emergent adverse events (TEAEs) occurring in 86.3% of those in the placebo group and for 90.3% of those in the rusfertide group in part 1a. In part 1b, TEAE rates were similar between groups at approximately 75%. The most common grade 3 TEAE were anemia, asthenia, and hypertension, Kuykendall noted. These occurred in 3 patients each. Serious AEs were experienced by 3.4% of patients in part 1a and by 2.6% in part 1b.
In part 1a of the study, injection site reactions occurred in 32.9% of those in the placebo group and in 55.9% in the rusfertide group. In part 1b, infusion site reactions were seen in 32.9% of those in the crossover group and for 9.7% in the rusfertide arm.
“Optimistically, you can see that some of the injection site reactions actually go down in the rusfertide arm from week 32 to 52, suggesting it may lessen over time,” Kuykendall said.
What are the next steps for rusfertide?
A regulatory submission is being planned for rusfertide as a treatment for patients with PV. Data for the submission will come from the VERIFY study along with results from the REVIVE study (NCT04057040). In the REVIVE study,2 the response rate with rusfertide was 60% compared with 17% for placebo (P = .002).
Parts 2 and 3 of the VERIFY study will continue to assess long-term efficacy and safety for rusfertide, with part 2 scheduled to go to week 156 and part 3 expending from the end of part 2 through the end of treatment.
References
Kuykendall A, Bankar A, Pettit K, et al. Rusfertide or placebo plus current standard-of-care therapy for polycythemia vera: Durability of response and safety results through week 52 from the randomized controlled phase 3 VERIFY study. Blood. 2025;146(suppl 1): 81. doi:10.1182/blood-2025-8
Kremyanskaya M, Kuykendall AT, Pemmaraju N, et al. Rusfertide, a hepcidin mimetic, for control of erythrocytosis in polycythemia vera. N Engl J Med. 2024;390(8):723-735. doi:10.1056/NEJMoa2308809
