Platinum

NeoCOAST-2 trial showed promising pathologic complete and major pathologic response rates with neoadjuvant datopotamab deruxtecan (Dato-DXd) plus durvalumab and single-agent platinum chemotherapy in early-stage NSCLC, surpassing historical benchmarks.

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.

FDA approved bortezomib for multiple myeloma and mantle cell lymphoma, atezolizumab and hyaluronidase-tqjs for subcutaneous use in all IV atezolizumab indications, ribociclib plus an aromatase inhibitor for HR+/HER2- breast cancer, pembrolizumab plus chemo for malignant pleural mesothelioma, amivantamab plus chemo for EGFR+ advanced NSCLC post EGFR inhibition, isatuximab plus VRd for newly diagnosed, transplant-ineligible multiple myeloma, osimertinib for locally advanced, unresectable EGFR+ NSCLC after chemoradiation, and selpercatinib for RET fusion+ medullary thyroid cancer.

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.

Merck's KEYTRUDA recommended by CHMP for approval in two gynecologic cancer indications: first-line treatment of advanced or recurrent endometrial carcinoma, and treatment of Stage III-IVA locally advanced cervical cancer. Pending EU approval expected in Q4 2024.

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.

FDA approves ribociclib for HR+/HER2– breast cancer, AMG 193 shows activity in MTAP-deleted tumors, pembrolizumab plus chemo for mesothelioma, neoadjuvant pembrolizumab/chemo boosts OS in TNBC, and experts discuss 2024 IASLC World Conference on Lung Cancer findings.