Platinum

The study involved 55 ESCC patient samples for PDO generation, achieving a 62% culture success rate. ESCOs replicated original tumor histology and were used for drug assays, showing varied responses to chemotherapeutics. PDOs' drug sensitivity correlated with clinical outcomes, indicating their potential in personalized oncology.

BeiGene's Tevimbra approved by U.S. FDA for treating HER2-negative gastric or gastroesophageal junction adenocarcinoma, marking its second U.S. approval this year. The approval follows a successful global Phase 3 trial. Tevimbra also approved for esophageal squamous cell carcinoma. BeiGene plans to rename to BeOne Medicines.

FDA approved zolbetuximab-clzb for CLDN18.2-positive, HER2-negative gastric/GEJ adenocarcinoma, in combination with chemotherapy. Dr. Marshall highlights the need for CLDN18.2 testing and the potential benefits and manageable toxicities of zolbetuximab, emphasizing ongoing challenges in GI cancer treatment.

ODAC meeting concluded unfavorable risk-benefit profile of PD-1 inhibitors in PD-L1–negative gastrointestinal cancers, with ongoing debate on optimal use in patients with PD-L1 expression 1%-10%. Uboha suggests immunotherapy for PD-L1 CPS ≥1%, noting variability in expression and need for better treatments. Tislelizumab approval pending, with survival benefits seen in PD-L1 TAP ≥10% patients. ODAC discussed limiting approvals based on biomarker-selected populations due to lack of benefit in PD-L1–negative tumors.

Merck announces positive Phase 3 trial results for subcutaneous pembrolizumab with berahyaluronidase alfa in metastatic NSCLC, meeting primary pharmacokinetic endpoints and showing noninferiority compared to IV KEYTRUDA.

The FDA's approval of zolbetuximab-clzb in combination with chemotherapy for HER2-negative, CLDN 18.2-positive gastric or gastroesophageal junction adenocarcinoma marks a significant shift towards precision medicine in treating this cancer. The approval, supported by the SPOTLIGHT and GLOW trials, highlights the potential of targeting CLDN 18.2 to improve patient outcomes, encouraging further research and timely biomarker testing.

Merck's Keytruda, in combo with pemetrexed and platinum chemotherapy, recommended by CHMP for 1st-line treatment of unresectable non-epithelioid malignant pleural mesothelioma in EU, based on KEYNOTE-483 trial results showing improved OS and PFS.

Merck receives EU CHMP positive opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM, based on IND.227/KEYNOTE-483 trial results.

Zolbetuximab, a CLDN18.2-targeted IgG1 monoclonal antibody, combined with frontline chemotherapy, extended PFS and OS in HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma patients positive for CLDN18.2, according to phase 3 SPOTLIGHT and GLOW trials. The FDA approved zolbetuximab in October 2024 for first-line treatment of these patients. Median PFS was 9.2 months with zolbetuximab vs 8.2 months with placebo, and median OS was 16.4 months vs 13.7 months, respectively. Zolbetuximab was also approved in Japan and Europe in 2024.

A study in JCO Oncology Practice shows negative outcomes during a 2-year etoposide shortage in Canada for ES-SCLC treatment, emphasizing the detrimental impact of drug shortages on patient outcomes and the need for consistent drug supply.