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 KEYNOTE-158 trial, the FDA converted pembrolizumab’s accelerated approval to traditional approval for adult and pediatric patients with previously treated unresectable or metastatic tumor mutational burden-high...
Based on results from the KEYNOTE-158 trial, the FDA converted pembrolizumab’s accelerated approval to traditional approval for adult and pediatric patients with previously treated unresectable or metastatic tumor mutational burden-high...
The FDA granted accelerated approval to dostarlimab for patients with stage II/III MSI-H/dMMR locally advanced rectal cancer, establishing an immunotherapy-based treatment option supported by sustained clinical complete responses and the...
The FDA granted accelerated approval to dostarlimab for patients with stage II/III MSI-H/dMMR locally advanced rectal cancer, establishing an immunotherapy-based treatment option supported by sustained clinical complete responses and the...
The FDA expanded the indication for nogapendekin alfa inbakicept plus Bacillus Calmette-Guérin (BCG) to include patients with high-grade papillary-only, BCG-unresponsive non-muscle-invasive bladder cancer, extending treatment eligibility...
The FDA expanded the indication for nogapendekin alfa inbakicept plus Bacillus Calmette-Guérin (BCG) to include patients with high-grade papillary-only, BCG-unresponsive non-muscle-invasive bladder cancer, extending treatment eligibility...
Results from a phase 3 trial demonstrated that pegylated liposomal doxorubicin significantly prolonged progression-free survival and objective response compared with placebo in patients with advanced or refractory desmoid tumors, supporting...
Results from a phase 3 trial demonstrated that pegylated liposomal doxorubicin significantly prolonged progression-free survival and objective response compared with placebo in patients with advanced or refractory desmoid tumors, supporting...
Topline results from the phase 3 EXCALIBER-RRMM trial demonstrated significantly prolonged progression-free survival with iberdomide plus daratumumab and dexamethasone compared with daratumumab, bortezomib, and dexamethasone in...
Topline results from the phase 3 EXCALIBER-RRMM trial demonstrated significantly prolonged progression-free survival with iberdomide plus daratumumab and dexamethasone compared with daratumumab, bortezomib, and dexamethasone in...
Results from a small study evaluating a resource-adapted treatment strategy for very-high-risk myelodysplastic syndromes demonstrated responses with cytarabine induction followed by azacitidine and lenalidomide, supporting further...
Results from a small study evaluating a resource-adapted treatment strategy for very-high-risk myelodysplastic syndromes demonstrated responses with cytarabine induction followed by azacitidine and lenalidomide, supporting further...
A retrospective analysis of patients with myelodysplastic syndromes undergoing allogenic hematopoietic stem cell transplantation identified acute myeloid leukemia transformation as the strongest independent predictor of post-transplant...
A retrospective analysis of patients with myelodysplastic syndromes undergoing allogenic hematopoietic stem cell transplantation identified acute myeloid leukemia transformation as the strongest independent predictor of post-transplant...
Topline results from the phase 3 EPCORE DLBCL-2 trial demonstrated that adding epcoritamab to R-CHOP significantly improved progression-free survival in newly diagnosed patients with diffuse large B-cell lymphoma, providing phase 3 evidence...
Topline results from the phase 3 EPCORE DLBCL-2 trial demonstrated that adding epcoritamab to R-CHOP significantly improved progression-free survival in newly diagnosed patients with diffuse large B-cell lymphoma, providing phase 3 evidence...
Results from the phase 2b SURVIVE trial showed a numerical overall survival improvement with SurVaxM in newly diagnosed patients with glioblastoma that did not reach statistical significance, while a prespecified subgroup of patients aged 65...
Results from the phase 2b SURVIVE trial showed a numerical overall survival improvement with SurVaxM in newly diagnosed patients with glioblastoma that did not reach statistical significance, while a prespecified subgroup of patients aged 65...
Based on results from the HER2CLIMB-05 trial, the FDA approved tucatinib plus trastuzumab and pertuzumab as maintenance treatment for HER2-positive advanced breast cancer following induction therapy, establishing a new maintenance option...
Based on results from the HER2CLIMB-05 trial, the FDA approved tucatinib plus trastuzumab and pertuzumab as maintenance treatment for HER2-positive advanced breast cancer following induction therapy, establishing a new maintenance option...