BeOne Medicines AG (ONC) News & EventsONCNews & EventsBeOne Medicines AG

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.

BeOne and Revolution Medicines Announce Multi-Part Collaboration

BeOne Medicines (ONC) and Revolution Medicines (RVMD) announced a multi-part collaboration including: a clinical collaboration to evaluate drug combinations incorporating select clinical-stage oncology assets from BeOne with any of Revolution Medicines' four clinical RAS(ON) inhibitors, and a separate regional rights agreement granting BeOne exclusive development and commercialization rights to these Revolution Medicines assets in select Asian markets. Clinical collaboration will explore potential targeted combination approaches for patients with RAS-addicted cancers. Potential drug combinations for development as part of the clinical collaboration will include certain BeOne assets and Revolution Medicines' four clinical RAS(ON) inhibitors. Under the regional rights agreement, Revolution Medicines has granted BeOne exclusive rights in select Asian markets to develop and commercialize or solely commercialize, depending on the market, these four clinical-stage RAS(ON) inhibitors. Revolution Medicines is eligible to receive development and sales milestone payments and tiered royalties on net sales in the partnered region. Revolution Medicines retains development and commercial rights to all its assets outside of the licensed territory, including Japan and South Korea. As part of this multi-part arrangement, BeOne will fund and conduct a global registrational Phase 3 study for one of Revolution Medicines RAS(ON) inhibitors, while Revolution Medicines continues to advance a broad range of global registrational studies across its portfolio.