Platinum

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.

Perioperative pembrolizumab improved event-free survival in stage III/IVA resected HNSCC, marking the first positive trial in 2 decades. A trend toward improved overall survival was observed but not statistically significant. Full results will be presented at a medical meeting and shared with regulatory authorities.

Nimy Resources (ASX: NIM) discovered high-grade copper-nickel-cobalt-PGE mineralisation at Masson within its Mons nickel project in WA. Drilling results show a broad zone with up to 236m depth of high-grade copper lens, extending 240m along strike and 61.5m down-hole. Best assays include 13m at 0.62% copper, 5.58m at 1.27% copper, and 11m at 0.36% copper. Nimy's executive director, Luke Hampson, calls Masson a significant discovery, suggesting further exploration of magnetic and EM anomalies.

The FDA’s Oncologic Drug Advisory Committee (ODAC) voted 11 to 1 against the use of checkpoint inhibitors (CPIs) in patients with metastatic or unresectable esophageal squamous cell carcinoma with PD-L1 expression less than 1, citing unfavorable risk-benefit assessment. The discussion focused on data from trials supporting the approvals of nivolumab, pembrolizumab, and tislelizumab, which showed marginal or unfavorable outcomes in patients with PD-L1 expression under 1, with higher benefits observed in those with expression over 1. The notable risks of CPIs, including immune-mediated adverse effects, were also highlighted.

Astellas Pharma’s Vyloy (zolbetuximab) approved by EC for first-line treatment of claudin 18.2-positive, HER2-negative gastric/GEJ adenocarcinoma, alongside chemotherapy. Vyloy, administered every 2-3 weeks, is the first EU therapy targeting claudin 18.2-expressing tumour cells, supported by phase 3 SPOTLIGHT and GLOW trial results.

Japan approves KEYTRUDA for NSCLC in perioperative setting and urothelial carcinoma, based on KEYNOTE-671 and KEYNOTE-A39/052 trials, respectively.

This study assesses the cost-effectiveness of atezolizumab and durvalumab combined with chemotherapy as first-line treatment for extensive-disease small-cell lung cancer (ED-SCLC) in Japan, finding ICERs of 35 and 37 million JPY, respectively, which exceed the 15 million JPY threshold per QALY. Sensitivity analysis suggests significant price reductions are needed for these treatments to be cost-effective, recommending clinical trials to explore smaller dosages and longer intervals to enhance efficiency.