ONC News & Events

BeOne Medicines announced data from the HERIZON-GEA-01 trial, published in The New England Journal of Medicine and to be presented at the ASCO Annual Meeting on June 1 in Chicago, which evaluated Ziihera - zanidatamab - plus chemotherapy, with and without Tevimbra - tislelizumab -, compared with the control arm of trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ gastroesophageal adenocarcinoma, or GEA. The regimen of tislelizumab added to zanidatamab plus chemotherapy demonstrated meaningfully improved outcomes for patients with HER2-positive GEA. Findings show that this regimen resulted in a survival benefit, even in patients with PD-L1 less than1%. A statistically significant and clinically meaningful improvement in OS with Ziihera plus Tevimbra and chemotherapy reached a median OS of 26.4 months. Progression-free survival showed a statistically significant and clinically meaningful improvement in both Ziihera-containing arms with a median PFS of 12.4 months. Median duration of response was 20.7 months with Ziihera and Tevimbra plus chemotherapy. The safety findings for the Ziihera plus Tevimbra and chemotherapy arm were generally consistent with known effects and no new safety signals were identified. The FDA has accepted a supplemental Biologics License Applications for Tevimbra and has granted it priority review. China's National Medical Products Administration has accepted sBLAs for Ziihera and Tevimbra for the first-line treatment of advanced/metastatic HER2+ GEA. BeOne holds the rights to Ziihera in Asia, Australia, and New Zealand, and intends to work with authorities in these markets to expedite regulatory submissions.

BeOne Medicines announced that the U.S. Food and Drug Administration has granted accelerated approval to Beqalzi, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor. "Beqalzi was designed to enhance BCL2 inhibition-with greater potency, selectivity, and a pharmacologic profile with potential to improve efficacy, tolerability, and convenience over others in the class," the company stated. Continued approval for this indication is contingent upon confirmation of clinical benefit in the confirmatory CELESTIAL-RRMCL trial, which is underway. The U.S. FDA granted Breakthrough Therapy Designation for sonrotoclax in this indication, as well as Fast Track Designation and Orphan Drug Designation.