Geoffrey Ku, MD, discusses findings from the phase 3 HERIZON-GEA-01 trial evaluating first-line zanidatamab plus chemotherapy, with or without tislelizumab, in patients with HER2-positive gastroesophageal adenocarcinoma, highlighting improved outcomes, the integration of immunotherapy irrespective of PD-L1 status, and key considerations for treatment selection and toxicity management
On August 25, 2026, the FDA approved zanidatamab plus chemotherapy, with or without tislelizumab, as a new first-line treatment for HER2-positive advanced gastroesophageal adenocarcinoma based on improved outcomes in the phase 3 HERIZON-GEA-01 trial.
Updated phase 3 HERIZON-GEA-01 results showed that zanidatamab-based regimens improved overall survival compared with trastuzumab plus chemotherapy in first-line HER2-positive advanced gastroesophageal adenocarcinoma, strengthening the evidence supporting zanidatamab as a HER2-targeted backbone following its recent FDA approval.
Based on results from the phase 3 SERENA-6 trial, the FDA granted accelerated approval to camizestrant plus a CDK4/6 inhibitor for HR-positive, HER2-negative advanced breast cancer following detection of an ESR1 mutation during ongoing...
Based on results from the phase 3 SERENA-6 trial, the FDA granted accelerated approval to camizestrant plus a CDK4/6 inhibitor for HR-positive, HER2-negative advanced breast cancer following detection of an ESR1 mutation during ongoing...
Early-phase results showed that daraxonrasib produced meaningful antitumor activity across dose levels in previously treated advanced RAS-mutant non–small cell lung cancer, supporting further evaluation of this oral RAS(ON) multiselective...
Early-phase results showed that daraxonrasib produced meaningful antitumor activity across dose levels in previously treated advanced RAS-mutant non–small cell lung cancer, supporting further evaluation of this oral RAS(ON) multiselective...
Topline results from the phase 3 CERVINO trial showed that etentamig significantly improved response and progression-free survival over standard available therapies in triple-class exposed relapsed or refractory multiple myeloma, supporting...
Topline results from the phase 3 CERVINO trial showed that etentamig significantly improved response and progression-free survival over standard available therapies in triple-class exposed relapsed or refractory multiple myeloma, supporting...
Results from the phase 3 HARMONi trial showed that ivonescimab plus chemotherapy improved progression-free survival compared with chemotherapy alone in patients with advanced EGFR-mutated NSCLC after progression on third-generation EGFR...
Results from the phase 3 HARMONi trial showed that ivonescimab plus chemotherapy improved progression-free survival compared with chemotherapy alone in patients with advanced EGFR-mutated NSCLC after progression on third-generation EGFR...
Updated results from the phase 3 AEGEAN trial showed that perioperative durvalumab plus neoadjuvant chemotherapy maintained an event-free survival benefit compared with neoadjuvant chemotherapy alone in patients with resectable non-small cell...
Updated results from the phase 3 AEGEAN trial showed that perioperative durvalumab plus neoadjuvant chemotherapy maintained an event-free survival benefit compared with neoadjuvant chemotherapy alone in patients with resectable non-small cell...
Five-year results from the phase 3 KEYNOTE-671 trial showed that perioperative pembrolizumab plus neoadjuvant chemotherapy provided durable event-free and overall survival benefits compared with neoadjuvant chemotherapy and surgery alone in...
Five-year results from the phase 3 KEYNOTE-671 trial showed that perioperative pembrolizumab plus neoadjuvant chemotherapy provided durable event-free and overall survival benefits compared with neoadjuvant chemotherapy and surgery alone in...
Topline results from the phase 2a NEO100-01 trial showed that intranasal NEO100 achieved a 48.9% 6-month progression-free survival rate in patients with recurrent IDH1-mutant high-grade glioma, significantly exceeding the prespecified 20%...
Topline results from the phase 2a NEO100-01 trial showed that intranasal NEO100 achieved a 48.9% 6-month progression-free survival rate in patients with recurrent IDH1-mutant high-grade glioma, significantly exceeding the prespecified 20%...
A real-world study of nirogacestat in patients with desmoid tumors demonstrated durable disease control, tumor responses, and meaningful pain improvement, with many patients also reducing or discontinuing analgesics, reinforcing the clinical...
A real-world study of nirogacestat in patients with desmoid tumors demonstrated durable disease control, tumor responses, and meaningful pain improvement, with many patients also reducing or discontinuing analgesics, reinforcing the clinical...
The FDA has approved rusfertide for the treatment of erythrocytosis in adult patients with polycythemia vera after results from the phase 3 VERIFY trial showed showed improved hematocrit control, reduced phlebotomy requirements, and improved...
The FDA has approved rusfertide for the treatment of erythrocytosis in adult patients with polycythemia vera after results from the phase 3 VERIFY trial showed showed improved hematocrit control, reduced phlebotomy requirements, and improved...