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ONC 事件
BeOne Medicines Releases New Survival Results from HERIZON-GEA-01 Trial
BeOne Medicines announced new survival results from the planned second interim analysis and final formal analysis of the Phase 3 HERIZON-GEA-01 trial, further confirming the benefit of TEVIMBRA plus ZIIHERA and chemotherapy as first-line treatment for patients with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. The results will be presented today as a late-breaking abstract during a rapid oral session at the European Society for Medical Oncology Congress 2026 in Madrid, Spain. This new analysis was conducted after 35.3 months of follow-up, an additional 9.4 months since the first interim analysis. Formal overall survival comparisons were tested sequentially, first comparing ZIIHERA plus chemotherapy with trastuzumab plus chemotherapy and then comparing TEVIMBRA plus ZIIHERA and chemotherapy with ZIIHERA plus chemotherapy. Key findings include: TEVIMBRA plus ZIIHERA and chemotherapy demonstrated sustained long-term survival versus trastuzumab plus chemotherapy. Median OS was 27.0 months, with an OS hazard ratio of 0.65, improved from 0.72 at the first interim analysis. This regimen is the only treatment for patients with HER2+ GEA to show a median overall survival of more than two years. ZIIHERA plus chemotherapy significantly improved OS versus trastuzumab plus chemotherapy. Median OS was 22.9 months versus 19.6 months, respectively, meeting the remaining primary endpoint of the study. Adding TEVIMBRA to ZIIHERA plus chemotherapy was associated with a four-month longer median OS at 27.0 months compared with ZIIHERA plus chemotherapy with 22.9 months. The difference did not reach statistical significance in the context of an underpowered analysis. A consistent trend toward improved OS was observed irrespective of PD-L1 status. Long-term survival was highest with the TEVIMBRA-containing regimen. Estimated 36-month OS was 39.8% with TEVIMBRA plus ZIIHERA and chemotherapy, 31.5% with ZIIHERA plus chemotherapy and 22.9% with trastuzumab plus chemotherapy. TEVIMBRA plus ZIIHERA and chemotherapy significantly improved progression-free survival versus trastuzumab plus chemotherapy, with median PFS of 12.7 months versus 8.3 months. Median PFS with ZIIHERA plus chemotherapy was 12.4 months versus trastuzumab plus chemotherapy. The safety findings for both experimental arms were generally consistent with the first interim analysis, and with the known profiles of the component therapies. No new safety signals were identified, and diarrhea was the most common Grade greater than or equal to3 treatment-related adverse event. A mandatory anti-diarrheal prophylaxis was established during the first cycle, with most diarrhea events occurring early in the treatment.
BeOne Medicines Announces Agreement with U.S. Government to Expand Access to Cancer Medicines
BeOne Medicines announced a voluntary agreement with the U.S. Government to "expand access to innovative cancer medicines for American patients while strengthening our U.S manufacturing footprint and further expanding the capabilities needed to deliver medicines at scale." The company said: "The agreement builds on BeOne's longstanding commitment to patient access and investment in research and scientific innovation. This announcement reflects BeOne's participation in the GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model and the company's commitment to pricing future FDA-approved products in line with other key developed markets." John Oyler, Co-Founder, Chairman and CEO, BeOne Medicines, said: "At BeOne, we believe every patient should benefit from innovative cancer therapies. We appreciate the Trump Administration's commitment to advancing solutions that broaden access and scientific progress for American patients. This agreement reflects our purpose to reach more patients as we expand our U.S. investment in additional research, development, and manufacturing to deliver breakthrough cancer treatments worldwide."
BeOne Medicines Reports Positive Results for Ziihera in Phase 3 Trial
BeOne Medicines announced positive topline results from the second interim analysis of the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera, in combination with chemotherapy, with and without Tevimbra, as first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma, GEA. At IA2, Ziihera plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival, OS, compared with trastuzumab plus chemotherapy, meeting the remaining primary endpoint analysis of the study.
BeOne Medicines' TEVIMBRA Approved by FDA for HER2 Positive Gastric Cancer
BeOne Medicines (ONC) announced that the U.S. FDA has approved the supplemental Biologics License Application for TEVIMBRA in combination with ZIIHERA and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma. The approval is supported by results from the Phase 3 HERIZON-GEA-01 trial, which were published in The New England Journal of Medicine earlier this year. The approval is based on data from HERIZON-GEA-01, the global Phase 3 clinical trial evaluating ZIIHERA plus chemotherapy, with and without TEVIMBRA, compared with trastuzumab plus chemotherapy as first-line treatment for advanced or metastatic HER2+ GEA. Key findings from the trial include: Overall survival: TEVIMBRA plus ZIIHERA and chemotherapy demonstrated a statistically significant improvement in OS, with median OS of 26.4 months compared with 19.2 months in the control arm. Progression-free survival: TEVIMBRA plus ZIIHERA and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS, with a median PFS of 12.4 months compared with 8.1 months in the control arm.
Zymeworks' Partner Jazz Receives FDA Approval for Ziihera Regimens
Zymeworks (ZYME) announced that its partner, Jazz Pharmaceuticals, has received U.S. Food and Drug Administration approval for two Ziihera-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma: Ziihera plus Tevimbra and fluoropyrimidine- and platinum-containing chemotherapy, and Ziihera plus fluoropyrimidine- and platinum-containing chemotherapy. This is the second FDA approval for zanidatamab in less than two years, further validating Zymeworks' proprietary Azymetric platform and its ability to discover and develop differentiated multifunctional antibodies for patients with difficult-to-treat cancers. The FDA approval of zanidatamab in GEA following its accelerated approval in biliary tract cancer, and with additional clinical trials underway by Jazz Pharmaceuticals (JAZZ) and BeOne Medicines (ONC) across other tumor types, together underscores the potential of Zymeworks' partnered drug development and royalty strategy to expand the potential reach of this important medicine to more patients across multiple tumor types. Each additional indication has the potential to increase the clinical impact of zanidatamab, while creating incremental value through our royalty interest and commercial milestone payments. "We believe this approach of supporting the development of innovative medicines while leveraging the resources and expertise of our partners, provides a capital-efficient pathway to participate in long-term patient benefit, and value creation for our shareholders." The approval is supported by results from the Phase 3 HERIZON-GEA-01 trial, which demonstrated the benefit of zanidatamab in combination with immunotherapy and chemotherapy in the first-line treatment of HER2+ GEA. Results from the study were published in the New England Journal of Medicine and first presented at ASCO GI 2026. The trial remains ongoing, with additional analyses planned. Under the terms of its collaboration with Jazz Pharmaceuticals, Zymeworks has earned a $250M milestone payment upon this approval, bringing total upfront and milestone payments received from Jazz to $650M. The company remains eligible to receive up to $1.3B in additional regulatory and commercial milestones, as well as tiered royalties of 10% to 20% on Jazz's net sales of zanidatamab in Jazz's licensed territories. Separately, under its collaboration with BeOne Medicines, Zymeworks has received $81M in upfront and milestone payments to date and remains eligible for up to $144M in additional milestones, plus tiered royalties of up to 19.5% on net sales in BeOne's licensed territories. Together, these collaborations provide significant non-dilutive capital and long-term royalty potential, supporting Zymeworks' disciplined capital allocation strategy, including investment in its wholly-owned R&D pipeline, strategic business development opportunities, and return of capital to shareholders.
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