Category: 3. Business

At the General Partners Meeting today, Uría Menéndez’s partners have decided to appoint Salvador Sánchez-Terán as the firm’s senior partner and Antonio Herrera as the managing partner. Both appointments will take effect on 1 January 2026. Jesús Remón, who is currently the firm’s senior partner, will remain associated with the firm as partner emeritus.

Salvador Sánchez-Terán

Following two terms as managing partner, during which time he has succeeded in further strengthening the firm’s position in the Iberian market, Salvador Sánchez-Terán will become the firm’s new senior partner. “It has been a real privilege to share the firm’s leadership with Jesús; his example will continue to serve as a benchmark for me and my colleagues,” said Salvador.

Antonio Herrera

Antonio Herrera joined Uría Menéndez in 1998 and has been a partner since 2007. He began his career in Madrid, later headed the New York office, and subsequently spent over a decade in charge of the Barcelona office. Since July 2024, he leads the Corporate Law Practice. His professional expertise includes M&A transactions, corporate governance, structured finance and advising start-ups. He has also been a professor at ESADE Law School for over ten years.

“I am grateful to my partners for their trust in me to take on this responsibility; it is an honour and a challenge that I embrace with great enthusiasm. I intend to build on the achievements of both Salvador and my predecessors, while continuing to develop Uría Menéndez in accordance with the principles that have always defined our firm: legal and ethical rigour, client dedication, commitment to internal talent and social responsibility”, said Herrera.

Following a distinguished career as a partner, Jesús Remón – who will remain at the firm as partner emeritus – stated that these appointments reflect “the continuity of our model, with a focus on long-term planning and generational renewal.” He also thanked the firm and its members for their unwavering support, and for giving him the opportunity to be part of this collective project.

Treatment with the pan-PI3K and mTORC1/2 inhibitor gedatolisib (PF-05212384) generated clinical activity in patients with metastatic castration-resistant prostate cancer (mCRPC) and patients with metastatic HER2-positive breast cancer, according to data from 2 separate clinical trials evaluating the agent.¹

Findings from the phase 1 portion of a phase 1/2 trial (NCT06190899) showed that patients with mCRPC (n = 36) treated with darolutamide (Nubeqa) in combination with gedatolisib at 120 mg (cohort 1) or 180 mg (cohort 2) experienced a 6-month radiographic progression-free survival (rPFS) rate of 66%. In this study, treatment-related adverse effects (TRAEs) did not lead to treatment discontinuation in any patients, and no patients required dose reductions of either agent due to TRAEs. No instances of grade 3 hyperglycemia were reported, and patients experienced grade 2/3 stomatitis at a rate of 10.5%.

“We are very encouraged by this preliminary efficacy and safety data,” Igor Gorbatchevsky, MD, chief medical officer of Celcuity, stated in a news release “The 66% 6-month rPFS rate for this novel combination therapy compares favorably to published data for androgen receptor inhibitors in this setting. With no treatment-related discontinuations and less than 3% of patients experiencing grade 3 stomatitis, we believe it is important to explore additional dose options for gedatolisib. Available gedatolisib pharmacokinetic data from other clinical trials in solid tumors suggests a relationship between efficacy and dose levels. Since this preliminary data indicates that the optimal gedatolisib dose for patients with mCRPC may not yet have been reached, the company amended the clinical trial protocol to enable exploration of additional doses in the phase 1/1b portion of this clinical trial to determine the recommended phase 2 dose.”

In a phase 2 study (NCT03698383), patients with pretreated, metastatic HER2-positive breast cancer harboring PIK3CA mutations (n = 44) administered the combination of gedatolisib and trastuzumab-pkrb (Herzuma) experienced an overall response rate (ORR) of 43% and a median PFS of 6.0 months (95% CI, 5.0-7.7). The median overall survival (OS) was 24.7 months (95% CI, 17.3-not applicable). Grade 3 hyperglycemia occurred in 1 patient (2.3%), and no patients discontinued gedatolisib due to TRAEs.

“The 43% ORR reported in patients who received at least 3 prior lines of anti-HER2 treatment for their disease is very encouraging and compares favorably to published data for other available therapies in this group of patients,” Gorbatchevsky stated. “The regimen was well tolerated, and no patients discontinued gedatolisib due to treatment-related AEs. While additional clinical studies are needed, this data suggests gedatolisib in combination with HER2 targeted therapy may be an effective and well tolerated therapeutic option for patients with HER2-positive metastatic breast cancer.”

mCRPC Trial Background

The phase 1/2 study is enrolling patients at least 18 years of age with histologically or cytologically confirmed adenocarcinoma of the prostate without a small cell component that is comprised of less than 10% neuroendocrine-type cells.² Patients need to have progressive mCRPC with prior treatment with a next-generation androgen receptor signaling inhibitor in the metastatic setting. An ECOG performance status of 0 or 1, along with adequate bone marrow, hepatic, renal and coagulation function, is also required.

In phase 1, patients are receiving gedatolisib at 120 mg or 180 mg once per week for 3 weeks on and 1 week off in combination with darolutamide at 600 mg per day in 28-day cycles. Phase 2 will evaluate the recommended dose of gedatolisib in combination with the same darolutamide regimen. Safety and determining the recommended phase 2 dose are the primary end points of phase 1. The primary end point of phase 2 is rPFS.

HER2-Positive Breast Cancer Trial Info

This phase 2 study enrolled patients at least 19 years of age with histologically or cytologically confirmed diagnosis of HER2-positive breast cancer with suspected PI3K pathway dependence.³ At least 2 HER-2 directed therapies, including trastuzumab (Herceptin) in the metastatic setting, was required. Patients also needed to have at least 1 measurable lesion per RECIST 1.1 criteria, an ECOG performance status of 0 to 1, and adequate bone marrow and organ function.

All enrolled patients received trastuzumab-pkrb at 6 mg/kg on day 1 of each 21-day cycle following a loading dose of 8mg/kg in cycle 1 in combination with gedatolisib at 180 mg on days 1, 8, and 15 of every 21-day cycle.

ORR was the trial’s primary end point. Secondary end points included PFS and OS.

References

1. Celcuity reports clinical data from two early phase studies of gedatolisib. News release. Celcuity. June 30, 2025. Accessed June 30, 2025. https://ir.celcuity.com/press-releases/?qmodStoryID=5588407709789214
2. Gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer. ClinicalTrials.gov. Updated March 21, 2025. Accessed June 30, 2025. https://clinicaltrials.gov/study/NCT06190899
3. Phase II study of Herzuma plus gedatolisib in patients with HER-2 positive metastatic breast cancer. ClinicalTrials.gov. Updated February 18, 2021. Accessed June 30, 2025. https://clinicaltrials.gov/study/NCT03698383

First-line treatment with bemarituzumab plus chemotherapy (mFOLFOX6) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) vs placebo plus chemotherapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive, according to findings from the phase 3 FORTITUDE-101 trial (NCT05052801).¹

In the study, FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry testing. With this, the primary end point of the phase 3 FORTITUDE-101 trial (NCT05052801) was met at its prespecified interim analysis.

Looking at safety, the most frequently reported treatment-emergent adverse events (TEAEs) occurring in more than 25% of patients receiving the bemarituzumab plus chemotherapy regimen included decreased visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelial defects, and dry eye. Ocular toxicities, which were consistent with findings from the phase 2 trial, occurred in both treatment arms but were notably more frequent and more severe in the bemarituzumab arm of the phase 3 study.

Full results from the trial will be presented at a future medical meeting.

“Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates, and limited therapeutic options,” said Jay Bradner, MD, executive vice president of research and development at Amgen, in a press release. “These first positive topline results of an FGFR2b targeted monoclonal antibody from our phase 3 FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer.”

The randomized, multicenter, double-blind, placebo-controlled, phase 3 FORTITUDE-101 trial evaluated bemarituzumab plus mFOLFOX6 vs placebo plus mFOLFOX6 as first-line therapy in 547 patients with advanced G/GEJ cancer with FGFR2b overexpression. The FORTITUDE-101 trial included 300 sites across 37 countries.

Enrollment was open to patients with histologically documented unresectable, locally advanced/metastatic G/GEJ cancer not amenable to curative therapy who had FGFR2b overexpression. Patients were required to have an ECOG performance status of 1 or less; measurable disease or nonmeasurable but evaluable disease, according to RECIST v1.1; no contraindications to mFOLFOX6 chemotherapy; and adequate organ and bone marrow function.²

The primary end point of the study is OS, and secondary end points include progression-free survival, overall response rate, number of patients who experience a TEAE, duration of response, disease control rate, pharmacokinetics.

In addition to FORTITUDE-101, a phase 3 trial (NCT05111626) is currently evaluating bemarituzumab plus chemotherapy and nivolumab (Opdivo) in patients with first-line gastric cancer. Data from this study are expected to read out in the second half of 2025.

REFERENCES:

1. Amgen announces positive topline phase 3 results for bemarituzumab in fibroblast growth factor receptor 2b (FGFR2B) positive first-line gastric cancer. News release. Amgen. June 30, 2025. Accessed June 30, 2025. https://tinyurl.com/2vck8tjj

2. Bemarituzumab or placebo plus chemotherapy in gastric cancers with fibroblast growth factor receptor 2b (FGFR2b) overexpression (FORTITUDE-101). News release. February 7, 2025. Accessed June 30, 2025. https://clinicaltrials.gov/study/NCT05052801

WestJet guests to gain single-connection access to multiple points in the Kingdom of Saudi Arabia for the first time

CALGARY, AB, June 30, 2025 /CNW/ – WestJet today announced a new interline partnership agreement with Saudia, significantly enhancing global connectivity across both carriers’ networks. The agreement includes single-connection access to Jeddah via Toronto Pearson as well as both Jeddah and Riyadh from London Heathrow and Paris Charles-de-Gaulle.

“An interline partnership with Saudia marks a major step forward in expanding global connectivity for our guests,” said John Weatherill, WestJet Executive Vice-President and Chief Commercial Officer. “This agreement not only provides WestJet guests with seamless single-connection access to Saudia’s extensive global network but also strengthens inbound tourism and business links. Together, WestJet and Saudia are creating more convenient and diverse travel options for guests on both sides, fostering stronger connections and collaboration across continents.”

Arved von zur Muehlen, Chief Commercial Officer at Saudia, said, “We value the partnership with WestJet, it reflects Saudia’s commitment to offer our guests more destinations through key international gateways. Canada is now closer than ever, and we are also offering a seamless journey for travellers from Canada to explore Saudi Arabia and experience its unique culture, heritage, and hospitality.”

The agreement was signed by Arved von zur Muehlen, Chief Commercial Officer at Saudia, and John Weatherill, Executive Vice-President and Chief Commercial Officer at WestJet.

Guests can now book a single ticket with a connected itinerary between WestJet and Saudia’s networks with single point check-in and through-checked bags. Bookings will be available through a travel agent or third-party ticket sales websites.

About WestJet      
WestJet took to the skies in 1996 with just over 200 employees and three aircraft operating service to five destinations. Since then, WestJet has pioneered low-cost travel in Canada, cutting airfares in half, and increasing the flying population in Canada by more than 50 per cent. Following integration with Sunwing in 2025, more than 14,000 WestJetters support nearly 200 aircraft and connect guests to more than 100 destinations across North America, Central America, the Caribbean, Europe and Asia.    

As a major Canadian employer that includes WestJet Airlines, Sunwing Vacations Group and WestJet Cargo, the WestJet Group is Canada’s leading low-cost airline and largest vacation provider, with a united purpose of providing affordable and accessible air and vacation travel to Canadians.    

Learn more about WestJet at westjet.com/en-ca/who-we-are (also available in French)  

Follow WestJet on Facebook at facebook.com/westjet   
Follow WestJet on X at x.com/westjet and x.com/WestJetNews   
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Subscribe to WestJet on YouTube at youtube.com/westjet    

SOURCE WESTJET, an Alberta Partnership

EnPot’s technology preserves the electrochemical process of aluminium production while allowing smelters to modulate energy by up to 30%

SIEMENS has signed a deal with EnPot, developer of a novel heat exchange technology, to help China’s huge aluminium industry use more renewable power.

EnPot, a New Zealand-based process development company, has developed a technology that allows aluminium smelters to modulate their power use. This would open the door for smelters to reduce their reliance on more dependable fossil fuels while contributing to grid stability.

Traditional smelter design requires a constant power supply to sustain the electrochemical reaction that produces aluminium and to maintain the heat balance within the pots – a reduction in power can cause severe damage.

EnPot’s technology uses a mechanical system of heat exchangers that preserve the electrochemical process while allowing smelters to modulate energy by up to 30% without disrupting the internal heat balance. This makes smelting more compatible with variable supplies of renewable power.

Siemens Energy designs energy management systems that integrate renewable power generation into existing facilities and optimise power use. Together the partners aim to help manufacturers integrate more renewable energy, improve energy efficiency and reduce operating costs.

China has strict targets for renewable energy to power 30% of its aluminium industry by 2027.

Karyna Young, CEO of EnPot, said: “China boasts more than 55% of the world’s aluminium smelters and counting. Like the rest of the world, they also see an urgent need to power the process with more energy from the sun, wind and lakes.

“This means they need to produce aluminium more flexibly by turning power consumption up or down on demand to match the availability of renewables. Numerous smelters in China have told our team they have an abundance of renewable energy that is next to impossible to take full advantage of without being able to dynamically balance the heat in the pots.”

EnPot’s technology was commercialised at a smelter in Essen, Germany in 2014 and expanded to a full potline of 120 pots in 2019.

For more on the technology, read a feature written by its developers.

“We’re thrilled to be back on board with Carnival, literally! From an ice-cold Coca-Cola with lunch, a Topo Chico by the pool, or a Powerade after exploring a destination, we’ll have the perfect drink for every moment of the journey,” said Dagmar Boggs, president, Foodservice & On-Premise, The Coca-Cola Company, North American Operating Unit. “This partnership is all about enhancing the guest experience, and we’re thrilled to offer a beverage lineup as diverse and exciting as the adventures Carnival guests embark on.”

Carnival anticipates the partnership will be fully integrated across its North American fleet by the end of September 2025. Carnival ships in Australia already serve Coca-Cola beverages.

For additional information on Carnival Cruise Line and to book a cruise vacation on Carnival, call 1-800-CARNIVAL, visit http://www.carnival.com, or contact your favorite travel advisor or online travel site.

Dive Brief:

• Keeping electricity affordable for consumers is a “formidable challenge” amid projections of declining generation capacity reserves and persistent uncertainty around the scale and pace of future load growth, ICF International Vice President of Energy Markets Maria Scheller said Thursday. 
• Meanwhile, broad policy uncertainty and an increasingly shaky regulatory environment give utilities and capital markets pause about expensive new infrastructure investments that could become stranded assets, Scheller said in a webinar on ICF’s “Powering the Future: Addressing Surging U.S. Electricity Demand” report.
• Policy conversations around import tariffs, federal energy tax credits and permitting reform are unfolding as the balance of electricity demand shifts from residential and business consumers to technology and industrial customers, which tend to require around-the-clock power, Scheller added.

Dive Insight:

The coming shift in U.S. electricity consumption represents less of a new paradigm than a return to the industrial-driven demand the country saw from the 1950s into the 1980s, after which deindustrialization and consumer-centric trends like the widespread adoption of air conditioning, electric resistance heating and personal computing shifted the balance toward the residential segment, Scheller said.

The shift is important because unlike residential loads, which show considerable seasonal and intraday variation, industrial loads are flatter, less weather-dependent and more sensitive to voltage fluctuations, Scheller said.

By 2035, ICF expects nearly 40% of total U.S. load will have a “flat, power-quality-sensitive profile,” and that overall load will grow faster than peak load, she said. In 2030, ICF projects more than 3% annual power consumption growth, compared with less than 2% annual peak load growth, according to a webinar slide.

That’s not to say residential demand won’t also grow in the next few years as consumers electrify home heating and buy more electric vehicles — only that data centers and other industrial demand will “dwarf” it, Scheller said.

The only significant regional exception to that expectation is California, where ICF says light- and heavy-duty transportation electrification will drive most load growth through 2040. 

Capacity reserves will quickly dwindle across most of the United States as a result of near-term load growth, regardless of the regional drivers, said Lalit Batra, ICF director of energy markets.

“We expect the capacity reserve across most regions to be absorbed in the next few years,” Batra said.

ICF sees nationwide capacity reserves — currently between 20% and 25% — below the 15% target reserve margin by 2030 and in negative territory by 2035, according to a webinar slide. Without a meaningful acceleration in new generation deployment, some combination of delayed power plant retirements, load flexibility or slower overall load growth will be needed to avoid shortages, Batra said.

Building new power plants fast enough to keep pace with load growth will be more difficult if Republicans in Congress effectively repeal the Inflation Reduction Act, according to ICF’s projections. If the final budget reconciliation bill preserves the rapid phaseout of clean energy tax credits in the version the U.S. House of Representatives passed in May, ICF projects the U.S. would deploy 280 GW fewer renewables and storage capacity and 43 GW more gas and nuclear through 2040, even as cost-competitiveness, supportive state policy and corporate power buyers’ preference for clean electricity supports robust regional markets for those technologies. 

Regardless of the policy scenario, ICF expects electricity prices to rise as much as 25% in some regions through 2030 due to necessary grid expansion, wildfire hardening and other infrastructure projects, along with gas price volatility, said Deb Harris, ICF vice president for climate change and sustainability. ICF expects U.S. gas prices to be 7% higher in 2035 and 17% higher in 2045 if the House budget becomes law relative to a status-quo scenario, according to a webinar slide.

Utilities and regulators already have the tools to mitigate some of these changes, Harris said. For example, demand response programs and flexible load interconnection could avoid about 30% of infrastructure investment costs that would otherwise be necessary, Harris said. Large loads are more open than some realize to ramping down load or investing in more efficient processes, such as liquid rather than air cooling of server racks, she added.

“These large load customers do offer a lot of opportunities” for efficiency and demand response, she said. “Energy is the number one [operating] cost they face.”

Permitting reforms like uniform siting standards, incentives for brownfield redevelopment and wider adoption of advanced GIS tools to locate “areas of minimal impact” for energy development could speed up new builds and keep prices in check, Harris added.

The catch, she said, is that while efforts to mitigate rising electricity prices may benefit customers and the politicians who represent them, project developers and their lenders and investors want to see durable price signals before committing to build new generation and transmission.

New data from a prespecified subgroup analysis of the phase 2 Actuate-1801 part 3B trial (NCT03678883) highlight the potential of elraglusib (9-ING-41), an investigational glycogen synthase kinase-3 beta (GSK-3β) inhibitor, in combination with gemcitabine/nab-paclitaxel (GnP) for first-line metastatic pancreatic adenocarcinoma (mPDAC) treatment.¹

The findings indicate a notable improvement in overall survival (OS) among patients receiving at least 1 complete cycle of elraglusib in conjunction with standard chemotherapy, particularly within the challenging subgroup of patients with liver metastases.

For patients who completed at least one 4-week cycle of therapy, the elraglusib/GnP combination arm achieved a median OS of 12.5 months compared with 8.5 months in the control arm. This represented a 43% reduction in the risk of death relative to the control group, underscoring the potential for early disease control with elraglusib.

Beyond OS, the combination therapy also demonstrated improved outcomes across several other key efficacy metrics. The disease control rate (DCR) was 53.4% in the elraglusib arm vs 44.8% in the control arm, while the overall response rate (ORR) improved to 37.9% compared with 29.3%. Median progression-free survival (PFS) was 6.9 months with elraglusib, an improvement over 5.6 months in the control group.

A particularly impactful finding emerged from the analysis of patients with liver metastases; a subpopulation historically associated with an exceptionally poor prognosis in mPDAC. In this group, treatment with elraglusib led to a 2.5-fold increase in 1-year OS and a 38% reduction in the risk of death compared to the control arm. While the GnP control arm showed 0% OS probability at 18 months, patients receiving elraglusib maintained a survival probability of 13.6% OS at 18 months. Additional efficacy metrics within this liver metastases subgroup further supported these observations: DCR was 36.8% vs 27.9%, ORR was 29.8% vs 19.7%, and PFS was 4.9 months vs 3.9 months in the elraglusib and control arms, respectively. The pronounced benefit observed in this high-risk population highlights elraglusib’s potential to address a critical unmet need.

“We are highly encouraged by the significant clinical benefit provided by elraglusib demonstrated in this study,” said Daniel Schmitt, president and chief executive officer of Actuate Therapeutics, in a press release. “These results underscore the potential of elraglusib to generate rapid and durable benefit in high-risk patients, which could be highly impactful in future development and commercial pathways.”

mPDAC represents an advanced and aggressive disease and accounts for approximately 90% of all pancreatic cancers. It is widely recognized as one of the deadliest malignancies, with a 5-year survival rate for metastatic cases under 10%.² This prognosis underscores the urgent need for novel and more effective therapeutic strategies.

Elraglusib’s mechanism of action involves the inhibition of GSK-3β, a serine/threonine protein kinase implicated in numerous cellular processes, including cell proliferation, differentiation, and survival.¹ GSK-3β plays a complex role, often promoting tumor growth and contributing to resistance against conventional cancer therapies, such as chemotherapy. By inhibiting GSK-3β, elraglusib aims to disrupt key molecular pathways in cancer that are involved in promoting tumor growth and resistance. Specifically, its activity targets pathways such as NF-kB of activated B cells and the DNA damage response.

Furthermore, preliminary research suggests elraglusib may also mediate antitumor immunity through the regulation of multiple immune checkpoints and immune cell function, potentially enhancing the body’s natural defenses against cancer. These multifaceted effects contribute to the drug’s observed clinical benefits.

REFERENCES:

1. Actuate Therapeutics highlights significant and sustained survival benefit in key metastatic pancreatic cancer patient populations in phase 2 elraglusib trial. News release. Actuate Therapeutics. June 24, 2025. Accessed June 26, 2025. https://tinyurl.com/muyufn2j

2. Sarantis P, Koustas E, Papadimitropoulou A, et al. Pancreatic ductal adenocarcinoma: treatment hurdles, tumor microenvironment and immunotherapy. World J Gastrointest Oncol. 2020;12(2):173-181. doi:10.4251/wjgo.v12.i2.173

At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone

THOUSAND OAKS, Calif., June 30, 2025 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival (OS) at a pre-specified interim analysis. 

Bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive. FGFR2b overexpression was defined as 2+/3+ staining in ≥10% of tumor cells by centrally performed immunohistochemistry (IHC) testing.

Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths globally each year ¹, highlighting a critical unmet medical need.

“Most patients with gastric cancer are diagnosed at an advanced stage, with poor prognosis, low survival rates and limited therapeutic options,” said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. “These first positive top-line results of an FGFR2b targeted monoclonal antibody from our Phase 3 FORTITUDE-101 study mark a meaningful advance in the development of effective targeted therapy for gastric cancer.”

The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye. While ocular events were consistent with the Phase 2 experience and observed in both arms, they occurred with greater frequency and severity in the Phase 3 bemarituzumab arm.

Detailed results from the trial will be shared at a future medical meeting.

FORTITUDE-101 was conducted with the support of Zai Lab. Zai Lab holds co-development and commercialization rights for bemarituzumab for mainland China, Hong Kong, Macau, and Taiwan.

A Phase 3 study of bemarituzumab plus chemotherapy and nivolumab is also ongoing in patients with first-line gastric cancer, with a data readout anticipated in H2 2025.

About FGFR2b 
The FGFR2b protein (also known as fibroblast growth factor receptor 2b) is an emerging biomarker which, when overexpressed, promotes aberrant signaling leading to tumor cell proliferation.²

The FGFR2b protein is overexpressed by G/GEJ tumor cells in approximately 38% of patients with advanced G/GEJ cancer. FGFR2b protein overexpression is defined as 2+/3+ staining intensity on tumor cell membrane, as detected by immunohistochemistry (IHC) testing. In approximately 16% of patients with advanced G/GEJ cancer, FGFR2b protein overexpression is observed on ≥10% of tumor cells by IHC.³

About FORTITUDE-101 
FORTITUDE-101 is a randomized, multi-center, double-blind, placebo-controlled Phase 3 study of bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 as first-line therapy in advanced G/GEJ cancer with FGFR2b overexpression. The FORTITUDE-101 trial spanned 300 sites across 37 countries, with 547 patients enrolled.

The primary outcome measure of the trial is overall survival in patients with FGFR2b ≥10% 2+/3+ tumor cell staining.  Key secondary outcome measures include progression-free survival and overall response rate. Candidates were excluded from the trial if they were known to be human epidermal growth factor receptor 2 (HER2) positive. FORTITUDE-101 included more comprehensive ocular-related monitoring than previous studies of bemarituzumab.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world’s toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average^®, and it is also part of the Nasdaq-100 Index^®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram,  YouTube and Threads. 

Amgen Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla^® (apremilast), our acquisitions of ChemoCentryx, Inc. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon’s business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media)Justin Claeys, 805-313-9775 (investors) 

REFERENCES

1. Bray F, et al. CA Cancer J Clin. 2024;74(3);229-263
2. Wainberg ZA, et al. Lancet Oncol. 2022;23(11):1430-40
3. Rha SY, et al. JCO Precis Oncol. 2025; 9 (e2400710). DOI:10.1200/PO-24-00710

 

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SOURCE Amgen