Category: 3. Business

  • ESMO 2025: GFH375 Shows Potential Against KRAS G12D Pancreatic Tumours

    ESMO 2025: GFH375 Shows Potential Against KRAS G12D Pancreatic Tumours

    Oncogenic KRAS mutations, particularly the G12D variant, are the most common drivers of pancreatic ductal adenocarcinoma (PDAC), accounting for roughly 40% of cases and predicting a poorer prognosis. This mutation is a crucial target for new therapies aiming to improve outcomes in this aggressive cancer type. GFH375 is a novel oral targeted therapy specifically designed to selectively inhibit KRAS G12D. It has shown encouraging early results in patients with previously treated advanced PDAC, offering new hope where treatment options have been limited.

    Promising Clinical Trial Results

    In an ongoing phase I/II study, 66 patients with KRAS G12D-mutant PDAC received daily doses of GFH375. The results so far have been remarkable: the objective response rate reached 41%, while the disease control rate stood at 97%. After a median follow-up of 141 days, progression-free survival at three months was 83%. Considering most participants had undergone multiple prior lines of therapy, these findings indicate the potential of GFH375 to deliver significant clinical benefit in a heavily pre-treated population.

    Manageable Safety Profile

    GFH375 demonstrated a manageable safety profile. Common treatment-related side effects included diarrhoea, neutrophil count decreases, nausea, and anemia, with few severe events leading to dose reduction or discontinuation.

    Biomarker Insights and Future Outlook

    Analysis of circulating tumour DNA revealed that 71% of patients had detectable KRAS G12D mutations in plasma, often accompanied by co-mutations in TP53, CDKN2A, and SMAD4. These biomarker findings may provide valuable insights into treatment response and disease progression. GFH375 continues to be evaluated in this trial and could represent a new targeted option for KRAS G12D–mutant pancreatic cancer as longer-term data emerge. Further study will clarify GFH375’s full potential and impact.

    Reference

    Zhou A et al. Efficacy and safety of GFH375 monotherapy in previously treated advanced KRAS G12D-mutant pancreatic ductal adenocarcinoma. ESMO; 17-21 October, Berlin, Germany.

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  • The Republic of Korea Selects L3Harris for Airborne Early Warning and Control Aircraft Program

    The Republic of Korea Selects L3Harris for Airborne Early Warning and Control Aircraft Program

    You can also consult this press release on the L3Harris website:
    The Republic of Korea Selects L3Harris for Airborne Early Warning and Control Aircraft Program | L3Harris® Fast. Forward.

    L3Harris Technologies (NYSE: LHX) has received a contract to deliver modified Bombardier Global 6500 airborne early warning and control (AEW&C) aircraft to the Republic of Korea Air Force. L3Harris is partnering with Bombardier, Israel Aerospace Industries’ ELTA Systems and Korean Air to provide this advanced capability. The program is valued at more than $2.26 billion.
    These aircraft will fly faster and operate longer to improve the nation’s mission readiness. They will also cruise at higher altitudes for improved safety and provide combat-proven radar coverage to more quickly detect and track threats. The communications suite will provide interoperability with the United States, NATO and coalition partners, creating a networked battlespace with fifth-generation aircraft and beyond. 
    “L3Harris is ready to deliver an advanced aircraft fleet that will strengthen mission effectiveness for a key American ally in the Indo-Pacific region,” said Christopher Kubasik, Chair and CEO, L3Harris. “We look forward to collaborating with the Republic of Korea to develop, test, integrate and sustain this vital capability for years to come.”
    “We are extremely pleased that the Bombardier Global 6500 will help the Republic of Korea Air Force defend its borders with L3Harris’ solution,” said Éric Martel, President and CEO, Bombardier. “Amid rising geopolitical tensions, this aircraft is the go-to choice for governments seeking to modernize their capabilities, with the reliability and performance to support the most demanding missions.”
    “This team brings together world-class, field-proven capabilities to deliver an AEW&C solution for the Republic of Korea,” said Boaz Levy, President and CEO, IAI. “Our team’s strategic special mission aircraft integrates innovative solutions and proven expertise, such as sensor miniaturization and advanced AESA radar technology, coupled with advanced detection and classification capabilities that enable success even in the most challenging missions.”
    “Throughout this collaboration, Korean Air will strengthen its capabilities in modification, integration and maintenance for the latest special mission aircraft,” said Jin Kyu Lim, Head of Aerospace Division, Korean Air. “As a leader in the domestic aerospace industry, we are committed to building a robust special mission aircraft sector and contributing to the nation’s defense capabilities.”
    In addition to supporting aircraft deliveries, Korean industry will take the lead in operating and maintaining the program, including meeting any future manufacturing requirements.

    About L3Harris Technologies

    L3Harris Technologies is the Trusted Disruptor in the defense industry. With customers’ mission-critical needs always in mind, our employees deliver end-to-end technology solutions connecting the space, air, land, sea and cyber domains in the interest of national security. Visit
    L3Harris.com for more information.

    About Bombardier Defense

    Bombardier Defense offers something unique, combining Bombardier’s portfolio of top-performing Challenger and Global aircraft with unparalleled engineering and maintenance expertise to create custom solutions. Known for its collaborative and flexible approach, Bombardier Defense builds long-term partnerships with governments and militaries, as well as joining forces with the world’s most advanced mission system providers. Driven by a rich history of innovation, we are shaping the defense solutions of the future. To learn more about Bombardier Defense, visit
    bombardier.com/defense and follow us on LinkedIn. For corporate news and information about Bombardier (BBD-B.TO), visit
    bombardier.com.

    About IAI

    Israel Aerospace Industries (IAI) is a world-leading aerospace and defense company innovating and delivering state-of-the-art technologies in space, air, land, naval, cyber for defense and commercial markets. Combining the spirit of innovation with decades of combat-proven experience, IAI provides customers with tailor-made, cutting-edge solutions to the unique challenges they face, including satellites, UAVs, missiles, intelligence solutions, weapon systems, air defense systems, robotic systems, radars, business jets, aerostructures, and more. Established in 1953, IAI is one of Israel’s largest technology employers with offices and R&D centers in Israel and abroad.

    About Korean Air

    Since 1978, Korean Air has successfully performed depot maintenance and various upgrade tasks for a total of over 5,500 South Korean and U.S. military aircraft at the Busan Tech Center, the largest military aircraft maintenance base in the Asia-Pacific region. Korean Air is expanding its work in technologies such as UAV special mission aircraft and a space launch vehicle.

    Forward-Looking Statements 

    This press release contains forward-looking statements that reflect management’s current expectations, assumptions and estimates of future performance and economic conditions. Such statements are made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The company cautions investors that any forward-looking statements are subject to risks and uncertainties that may cause actual results and future trends to differ materially from those matters expressed in or implied by such forward-looking statements. Statements about order values are forward-looking and involve risks and uncertainties. L3Harris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

    Media Contacts

    Re-Essa Buckels
    Integrated Mission Systems
    Re-essa.Buckels@L3Harris.com
    469-430-6395

    Sara Banda
    Corporate
    Media@L3Harris.com
    321-306-8927
     

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  • Sanrio’s CEO on expanding beyond Hello Kitty and traditional retail to succeed in global markets

    Sanrio’s CEO on expanding beyond Hello Kitty and traditional retail to succeed in global markets

    Tomokuni Tsuji speaks with Monocle about retail expansion in Asia, new character strategies, and why the brand’s enduring focus on joy keeps its business thriving across generations.

    When Tomokuni Tsuji became president and CEO of Sanrio in 2020, he made headlines as Japan’s youngest-ever chief executive of a listed company. The grandson of founder Shintaro Tsuji was just 31 when he took the helm and has since overseen a new chapter for the company behind Hello Kitty, one of Japan’s most beloved cultural exports.

    Under Tsuji’s leadership, Sanrio has entered a new era. The company achieved record growth, becoming a trillion-yen enterprise in 2024 as Hello Kitty celebrated her 50th anniversary.

    With theme parks, a robust licensing business and nearly 150 stores in Japan (not to mention a cast of more than 450 characters), Sanrio continues to expand its global footprint and deepen its connection with fans around the world.

    Monocle spoke to the young CEO during his recent visit to London, where Sanrio is serving as a major sponsor of the Grand Sumo Tournament at the Royal Albert Hall.

    Main character: Tomokuni Tsuji (Image: Getty)

    Hello Kitty recently appeared in support of the Grand Sumo Tournament. Why was this collaboration an important moment for Sanrio?
    Sanrio’s aim has always been to bring smiles to as many people as possible and this crossover of sport and Hello Kitty was sure to do so. Hello Kitty hails from London and King Charles wished her a happy birthday last year, which was a huge honour for us. We hoped that our involvement in the sumo tournament would excite people in the UK too. 

    Under your leadership, Sanrio has seen strong growth. What have been the key adjustments and strategies driving that success?
    Well, our success isn’t just down to me. It was achieved with the help of everyone around me. We’ve had a series of structural reforms within the company, which has helped to strengthen the organisation and refine our character strategy. We are starting to focus more on some of our other characters besides Hello Kitty, which, alongside a smart social-media strategy, is helping the brand to stay strong.

    When you mention shifting focus to characters beyond Hello Kitty, which ones do you see resonating most strongly with global audiences?
    While Hello Kitty will still be at the heart of what we do, our audience will be seeing more of our other characters such as My Melody, Kuromi and Cinnamoroll.

    Hello Kitty currently makes up about 35 per cent of the company’s sales and we don’t want that to go down as the other designs become more popular. We want to increase the sales of all characters simultaneously.

    Sanrio currently operates 150 stores in Japan. Where do you see the greatest opportunities for international retail growth and could that work beyond traditional shops?
    The number of our shops in Asia is growing steadily, especially in China, and we would like to branch out into North American and European markets too. But we are also looking to create customer touch-points beyond traditional shops. Of course, bricks-and-mortar retail will always be part of our plan but we will also be focusing on location-based entertainment that will create real opportunities for customers to come into contact with the brand.

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  • New Zealand Inflation Pressures Highest in Over a Year

    New Zealand Inflation Pressures Highest in Over a Year

    By James Glynn

    SYDNEY--Inflation pressures in New Zealand rose to their highest level since mid-2024 in the third quarter, curbing the central bank's ability to cut interest rates much further even as economic activity remains flat.

    The consumer price index increased by 3.0% from year earlier, with the CPI up 1.0% over the quarter, Stats NZ said Monday. The annual increase followed a 2.7% annual rise in the prior quarter.

    With inflation now back at the top of the Reserve Bank of New Zealand's 1% to 3% target band, the outlook for interest rates is more clouded.

    The RBNZ delivered an emergency 50-basis-point cut in interest rates at the start of the month, reacting to a torrent of weak economic data that included a sharp contraction in economic growth in the second quarter.

    Still, with inflation heating up, more cautious cuts are likely from here, according to economists.

    The RBNZ has slashed interest rates hard over the last year, but the economy remains weak and unemployment is elevated.

    The central bank has indicated that more cuts are coming.

    Economic growth stalled in the second quarter, with national output contracting by 0.9% from the first quarter. Growth was flat in annual terms.

    The largest contributors to the annual inflation rate in the third quarter were all in the housing and household utilities group, with electricity prices soaring by 11.3% and rents up 2.6%, the data showed. Local authority rates and payments were up 8.8%.

    The annual increase in electricity prices was the largest since the first quarter of 1989 when they rose 12.8%. Still, the increase in rents was the smallest annual increase in over four years.

    -Write to James Glynn at james.glynn@wsj.com

    (END) Dow Jones Newswires

    October 19, 2025 18:32 ET (22:32 GMT)

    Copyright (c) 2025 Dow Jones & Company, Inc.

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  • New Zealand's annual inflation hits 3%, top of central bank's target band – Reuters

    1. New Zealand’s annual inflation hits 3%, top of central bank’s target band  Reuters
    2. Bad news for the Reserve Bank as inflation tipped to top 3%  NZ Herald
    3. Reserve Bank’s cuts to Cash Rate challenged by Westpac Chief Economist  Newstalk ZB
    4. New Zealand’s CPI inflation rises to 3.0% YoY in Q3, as expected  FXStreet
    5. New Zealand Inflation Hits 3% As Housing And Veggies Get Pricier  Finimize

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  • Enrique Grande, MD, on the DISCUS trial, evaluating 3 vs 6 cycles of chemotherapy in UC

    Enrique Grande, MD, on the DISCUS trial, evaluating 3 vs 6 cycles of chemotherapy in UC

    In total, the study included 267 patients who were randomly assigned to receive 3 vs 6 cycles of platinum-based chemotherapy followed by maintenance avelumab. Overall, 78% and 40% of patients completed all 3 and 6 cycles, respectively, of allocated treatment.

    The average change in quality of life from baseline to cycle 6 was 0 (95% CI, -5.9 to 5.2) in the 3-cycle arm vs -8.5 (95% CI, -14.1 to -2.9) in the 6-cycle arm. The difference between groups was clinically significant, favoring the 3-cycle arm (95% CI, 0.7 to 16.3; P = .016).

    Regarding efficacy, there was no significant difference between the 2 groups in terms of overall response rate (ORR). Specifically, the ORR was 24% in the 3-cycle arm vs 27% in the 6-cycle arm. Further, the median progression-free survival was 8.0 months (95% CI, 6.7 to 11.9) in the 3-cycle arm vs 9.0 months (95% CI, 6.9 to 12.7) in the 6-cycle arm. The median overall survival was 18.9 months in both arms (HR, 1.15; 95% CI, 0.72 to 1.86; P = .56).

    Grade 3 to 4 treatment-related adverse events were reported in 11.9% of patients in the 3-cycle arm and 15.7% of patients in the 6-cycle arm.

    REFERENCE

    1. Grande E, Hussain SA, Duran MAC, et al. LBA109 – DISCUS: A phase II study comparing 3 vs 6 cycles of platinum-based chemotherapy prior to maintenance avelumab in advanced urothelial cancer. Presented at: 2025 European Society for Medical Oncology Congress. October 17-21, 2025. Berlin, Germany. LBA109

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  • Kering to sell beauty unit to L'Oreal for $4.66 billion – Reuters

    1. Kering to sell beauty unit to L’Oreal for $4.66 billion  Reuters
    2. Exclusive | Gucci Owner Kering Nears $4 Billion Sale of Beauty Unit to L’Oréal  wsj.com
    3. Kering to sell beauty unit to L’Oreal for $4.66 billion By Reuters  Investing.com
    4. Gucci owner Kering is said to be nearing deal to sell Beauty unit to L’Oréal  Seeking Alpha
    5. Kering and L’Oréal forge an alliance in beauty and wellness  GlobeNewswire

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  • ESMO 2025: A Phase III Study of Capivasertib + Abiraterone versus Placebo + Abiraterone in Patients with PTEN-deficient De Novo Metastatic Hormone-sensitive Prostate Cancer (mHSPC): CAPItello-281 – UroToday

    1. ESMO 2025: A Phase III Study of Capivasertib + Abiraterone versus Placebo + Abiraterone in Patients with PTEN-deficient De Novo Metastatic Hormone-sensitive Prostate Cancer (mHSPC): CAPItello-281  UroToday
    2. Truqap Extends Radiographic Progression-Free Survival in Some With Prostate Cancer  CUREtoday.com
    3. Capivasertib prolongs rPFS in PTEN-deficient hormone-sensitive prostate cancer  Urology Times

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  • Kering and L’Oréal Forge an Alliance in Beauty and Wellness

    Kering and L’Oréal Forge an Alliance in Beauty and Wellness

    Paris and Clichy, France. October 19, 2025 – Kering and L’Oréal announced today that they are entering a long-term strategic partnership in luxury beauty and wellness. This binding agreement encompasses the acquisition of the House of Creed by L’Oréal, the beauty and fragrance licenses of iconic Houses of Kering and an exclusive venture to explore business opportunities in the field of wellness and longevity.  

     

    Building on the success of Yves Saint Laurent Beauté, this alliance further consolidates the long history of collaboration of two global leaders with complementary strengths — iconic luxury brands of Kering and the world-class expertise of L’Oréal in beauty — to accelerate growth and unlock considerable value across high-potential categories.

     

    Under the terms of this agreement, Kering has the right to sell Kering Beauté including the House of Creed to L’Oréal. A true heritage name in haute parfumerie, Creed stands among the leading high-end luxury fragrance Houses, celebrated for its craftsmanship and mastery of rare natural ingredients. As part of L’Oréal Luxe, Creed will be best positioned to accelerate even further its global development across both men’s and women’s markets.

     

    The partnership includes the rights to enter into a 50-year exclusive license for the creation, development, and distribution of fragrance and beauty products for Gucci, commencing after expiration of the current license with Coty, and respecting the Kering group’s obligations as per the existing license agreement. 

    Kering will also grant L’Oréal 50-year exclusive licenses for the creation, development, and distribution of fragrance and beauty products for Bottega Veneta and Balenciaga, starting upon closing of the announced transaction.

     

    A strategic committee will be established to ensure coordination between Kering brands and L’Oréal and monitor the progress of our partnership.

     

    The agreement, including the sale of Creed and the establishment of these 50-year licenses on these iconic Houses of Kering, is valued at €4 billion, payable in cash at closing, expected in the first half of 2026. L’Oréal will also pay royalties to Kering for the use of its licensed brands.

     

    Beyond beauty, Kering and L’Oréal are joining forces to explore business opportunities at the intersection of luxury, wellness, and longevity. This exclusive partnership, in the form of a planned 50/50 joint venture, will craft cutting-edge experiences and services combining L’Oréal’s innovation capabilities with Kering’s deep understanding of luxury clients.

     

    This strategic alliance marks a decisive step for Kering,” declared Luca de Meo, CEO of Kering. “Joining forces with the global leader in beauty, we will accelerate the development of fragrance and cosmetics for our major Houses, allowing them to achieve scale in this category and unlock their immense long-term potential, as did Yves Saint Laurent Beauté under L’Oréal’s stewardship. Together, we will also venture into new frontiers of wellness, combining the unrivalled expertise of L’Oréal with our unique luxury reach. This partnership allows us to focus on what defines us best: the creative power and desirability of our Houses.”

     

    “I am delighted to forge this long-term strategic alliance with one of the world’s most prestigious, creative and visionary luxury groups. This partnership will further solidify our position as the world’s #1 luxury beauty company and allow us to explore new avenues in wellness together.” said Nicolas Hieronimus, CEO L’Oréal Groupe. “The addition of these extraordinary brands perfectly complements our existing portfolio and significantly expands our reach into new, dynamic segments of luxury beauty. Through Creed, we will establish ourselves as one of the leading players in the fast-growing niche fragrance market. Gucci, Bottega Veneta and Balenciaga are all exceptional couture brands with enormous potential for growth.”

     

    The agreement contains customary terms and conditions, including regulatory approvals. The agreement is also subject to Kering’s obligations under French employment law, with the right for Kering to sell Kering Beauté to L’Oréal and an exclusivity granted to L’Oréal.

     

    About Kering

     

    Kering is a global, family-led luxury group, home to people whose passion and expertise nurture creative Houses across couture and ready-to-wear, leather goods, jewelry, eyewear and beauty: Gucci, Saint Laurent, Bottega Veneta, Balenciaga, McQueen, Brioni, Boucheron, Pomellato, Dodo, Qeelin, Ginori 1735, as well as Kering Eyewear and Kering Beauté. Inspired by their creative heritage, Kering’s Houses design and craft exceptional products and experiences that reflect the Group’s commitment to excellence, sustainability and culture. This vision is expressed in our signature: Creativity is our Legacy. In 2024, Kering employed 47,000 people and generated revenue of €17.2 billion.

     

    About L’Oréal Groupe

     

    For 115 years, L’Oréal, the world’s leading beauty player, has devoted itself to one thing only: fulfilling the beauty aspirations of consumers around the world. Our purpose, to create the beauty that moves the world, defines our approach to beauty as essential, inclusive, ethical, generous and committed to social and environmental sustainability. With our broad portfolio of 37 international brands and ambitious sustainability commitments in our L’Oréal for the Future programme, we offer each and every person around the world the best in terms of quality, efficacy, safety, sincerity and responsibility, while celebrating beauty in its infinite plurality.

    With more than 90,000 committed employees, a balanced geographical footprint and sales across all distribution networks (e-commerce, mass market, department stores, pharmacies, perfumeries, hair salons, branded and travel retail), in 2023 the Group generated sales amounting to 41.18 billion euros. With 20 research centers across 11 countries around the world and a dedicated Research and Innovation team of over 4,000 scientists and 6,400 Digital talents, L’Oréal is focused on inventing the future of beauty and becoming a Beauty Tech powerhouse. 

     

     

    Contacts Kering

    Press

    Emilie Gargatte       +33 (0)1 45 64 61 20       emilie.gargatte@kering.com 
    Caroline Bruel       +33 (0)1 45 64 62 53       caroline.bruel-ext@kering.com  
        
    Analysts/investors

    Claire Roblet       +33 (0)1 45 64 61 49       claire.roblet@kering.com  
    Aurélie Husson-Dumoutier        +33 (0)1 45 64 60 45       aurelie.husson-dumoutier@kering.com

     

     

    Contacts L’Oréal

    Individual shareholders

    Pascale Guérin      +33 (0)1 49 64 18 89       pascale.guerin@loreal.com 
     

    Financial analysts and institutional investors

    Eva Quiroga       +33 (0)7 88 14 22 65       eva.quiroga@loreal.com 
     

    Media

    Brune Diricq       +33 (0)6 63 85 29 87       brune.diricq@loreal.com  
    Arnaud Fraboul       +33 (0)6 40 13 62 14       arnaud.fraboul@loreal.com  

     

     

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  • Bispecific ADC Iza-Bren Leads to Improved ORR Vs Chemo in Nasopharyngeal Cancer | Targeted Oncology

    Bispecific ADC Iza-Bren Leads to Improved ORR Vs Chemo in Nasopharyngeal Cancer | Targeted Oncology

    Patients treated with izalontamab brengitecan (iza-bren; BL-B01D1) had superior overall response rate (ORR) compared with chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC), according to results from the BL-B01D1-301 study (NCT06118333) presented at the 2025 European Society for Medical Oncology (ESMO) Congress and published in The Lancet.1,2

    The ORR by blinded independent central review was 54.6% (95% CI, 45.2%–63.8%) with iza-bren vs 27.0% (95% CI, 19.1%–36.0%) with chemotherapy, with an odds ratio of 3.3 (95% CI, 1.9–5.8; P < .0001) showing it was significantly higher in this primary end point.1

    “This was the first randomized phase 3 study evaluating iza-bren in recurrent or metastatic NPC. Our study has met its primary end point for ORR, and we can see a clinically meaningful improvement in progression-free survival [PFS] and it has a management safety profile,” said Huaqiang Zhou, MD, of Sun Yat-sen University Cancer Center in Guangzhou, China, in his presentation.1

    Approximately 20% to 30% of patients with NPC have recurrent or distant metastases, and current treatment options have low response rates. Iza-bren is a potentially first-in-class topoisomerase 1 inhibitor-based EGFR and HER3 bispecific antibody-drug conjugate (ADC).

    The multicenter, randomized, open-label, phase 3 BL-B01D1-301 trial was designed to investigate this agent in patients who had previously received at least 2 lines of systemic chemotherapy including at least 1 platinum-containing regimen and a PD-1 or PD-L1 inhibitor. The primary end points were ORR and overall survival (OS), with secondary end points including progression-free survival, duration of response (DOR), and safety.

    Patients were enrolled in 55 hospitals in China. They were stratified by number of prior lines of platinum-based treatment, ECOG performance status of 0 vs 1, and presence/absence of liver metastases.

    Of 522 patients who were screened, 386 were randomly assigned on a 1:1 basis with 191 receiving 2.5 mg/kg iza-bren on days 1 and 8 of a 3-week cycle with 195 receiving physician’s choice of chemotherapy.1

    The median age of patients was 50.0 in the treatment arm and 49.0 in the chemotherapy arm, with the majority being male in each arm (85.3% and 81.0%, respectively). The majority had ECOG performance status of 1 (75.9% in both arms). Over half of patients in both arms had received 2 prior lines of therapy with the rest having received at least 3 lines. The majority had received 2 prior lines of chemotherapy, with 48.2% of each arm having received 2 prior lines of platinum-based chemotherapy. Prior radiotherapy had been used in 89.5% of the experimental arm and 88.2% of the control arm.

    Metastases were present at baseline in the liver, bones, and lungs in 47.6%, 49.2%, and 46.6% of the experimental arm and 48.7%, 46.7%, and 37.4% of the control arm.

    Results were reported at median follow-up of 7.66 months for iza-bren and 7.10 months for chemotherapy. There was 1 complete response in the iza-bren arm and none in the control arm. The disease control rate was 82.4% with iza-bren vs 69.6% with chemotherapy. All subgroups favored iza-bren in this analysis.

    The median DOR was 8.5 months for iza-bren vs 4.8 months for physician’s choice of chemotherapy (HR, 0.43; 95% CI, 0.22–0.83). The median PFS was 8.38 months with iza-bren vs 4.34 months for chemotherapy (HR, 0.44; 95% CI, 0.32–0.62), and this trend was consistent across subgroups. At this time, OS was not mature.

    Treatment-related adverse events (TRAEs) of grade 3 or higher were reported in 79.9% of patients receiving iza-bren vs 61.6% of those receiving chemotherapy. Serious TRAEs occurred in 43.4% of patients in the iza-bren arm vs 27.0% in the chemotherapy arm, and 4 (2%) treatment-related deaths occurred in the iza-bren group. Dose reductions due to TRAEs were needed in 41.8% with iza-bren vs 24.3% with chemotherapy, and TRAEs leading to dose interruption occurred in 61.4% vs 18.4%, respectively. TRAEs led to treatment discontinuation in 2.6% vs 3.2%, respectively.

    Hematological AEs were reported more frequently with iza-bren vs chemotherapy including anemia in 50% vs 10% and decreased platelet count in 43% vs 7%. Decreased white blood cell count occurred in 43% vs 44% and decreased neutrophil count occurred in 38% vs 41%, respectively. According to Zhou, these were well managed by standard supportive care. The majority of nonhematologic TRAEs were grade 1 or 2, and no new safety signals were identified.

    Two cases of grade 2 interstitial lung disease (ILD) occurred in the experimental arm and 2 cases of grade 3 ILD occurred in the chemotherapy arm.

    “Based on this trial, iza-bren represents a potential new standard of care for heavily pretreated patients with recurrent or metastatic NPC,” concluded Zhou.

    REFERENCES:
    1. Yang Y, Zhou H, Tang L, et al. Iza-bren (BL-B01D1), an EGFR×HER3 bispecific antibody-drug conjugate, versus physician’s choice of chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma: a randomized, open-label, multicenter, phase III, pivotal study (BL-B01D1-303). Presented at: 2025 European Society for Medical Oncology Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA35.
    2. Yang Y, Zhou H, Tang L, et al. Izalontamab brengitecan, an EGFR and HER3 bispecific antibody–drug conjugate, versus chemotherapy in heavily pretreated recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 study in China. Lancet. Published online October 19, 2025. doi:10.1016/S0140-6736(25)01954-3

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