Platinum

The phase 3 KEYVIBE-008 trial found that co-formulated vibostolimab and pembrolizumab plus etoposide and platinum did not meet the primary end point of overall survival (OS) in extensive-stage small cell lung cancer (ES-SCLC) compared to atezolizumab plus EP. Median OS was 11.5 months vs 12.9 months, and median progression-free survival (PFS) was 5.3 months vs 4.5 months. The trial was discontinued due to the benefit/risk profile, though investigation continues in non–small cell lung cancer (NSCLC).

Merck and Moderna expand INTerpath clinical trial program to evaluate mRNA-4157 (V940) in combination with KEYTRUDA for early-stage non-small cell lung cancer, aiming to improve outcomes and offer more treatment options.

Astellas Pharma’s Vyloy (zolbetuximab-clzb) approved by FDA for first-line treatment of CLDN18.2-positive, HER2-negative gastric or gastro-oesophageal junction adenocarcinoma, in combination with chemotherapy. Supported by SPOTLIGHT and GLOW trials, Vyloy shows improved progression-free and overall survival. Now approved in US, EU, UK, Japan, and South Korea.

FDA approves Vyloy (zolbetuximab-clzb) with fluoropyrimidine- and platinum-based chemo for first-line treatment of locally advanced, unresectable or metastatic, HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors. Supported by phase 3 trials GLOW and SPOTLIGHT, Vyloy improved progression-free and overall survival. Common adverse events include nausea, vomiting, fatigue, and diarrhea. Vyloy is supplied as a 100 mg lyophilized powder for intravenous infusion.

Astellas Pharma secures FDA approval for Vyloy, a CLDN18.2-targeted therapy combined with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma. Vyloy is the first such therapy approved in the US, with Roche providing the companion diagnostic test. The approval is based on Phase 3 SPOTLIGHT and GLOW trials showing improved progression-free and overall survival.

The FDA approved Astellas Pharma Inc.’s VYLOY (zolbetuximab-clzb) for first-line treatment of CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma. VYLOY is the first CLDN18.2-targeted therapy in the U.S., approved based on Phase 3 SPOTLIGHT and GLOW trials showing improved progression-free and overall survival. Common side effects include nausea, vomiting, and decreased appetite.

FDA approves VYLOY (zolbetuximab-clzb) for first-line treatment of CLDN18.2-positive, HER2-negative gastric/GEJ adenocarcinoma, in combination with chemotherapy. VYLOY is the first CLDN18.2-targeted therapy in the U.S., approved based on Phase 3 SPOTLIGHT and GLOW trials showing improved PFS and OS. Common side effects include nausea, vomiting, and decreased appetite.

FDA approves zolbetuximab plus chemo for CLDN18.2+ gastric or GEJ adenocarcinoma; Gilead to withdraw sacituzumab govitecan indication in urothelial cancer; FDA approves Optune Lua for metastatic NSCLC after platinum-based chemotherapy; Verastem Oncology to submit NDA for avutometinib/defactinib combo in KRAS+ ovarian cancer; lurbinectedin/atezolizumab combo improves survival in ES-SCLC.

FDA approves zolbetuximab-clzb plus chemotherapy for HER2-negative, CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma. Phase 3 trials SPOTLIGHT and GLOW showed significant improvements in progression-free survival (PFS) and overall survival (OS) with zolbetuximab regimen compared to standard care, with similar treatment-related adverse events.

Durvalumab showed similar radiation pneumonitis incidences to placebo in LS-SCLC patients, with manageable safety profile, according to ADRIATIC trial results presented at 2024 ASTRO Annual Meeting.