The global Phase III TroFuse-005 study presented and published online on 26 October found both overall-survival and progression-free-survival gains for sacituzumab tirumotecan versus physician-choice chemotherapy after platinum and PD-1/L1 therapy in advanced or recurrent…
Global Phase III KEYNOTE-C93 data presented and published online 26 October show markedly longer progression-free survival with pembrolizumab alone than carboplatin–paclitaxel in untreated or recurrent mismatch-repair-deficient advanced endometrial cancer. Overall survival has not yet…
Detailed randomized Phase 3 results strengthen the case that individualized neoantigen vaccination can add to adjuvant PD-1 blockade in resected high-risk melanoma. The observed benefit is in recurrence and distant-metastasis endpoints; overall survival and…
The European Commission authorized pembrolizumab plus enfortumab vedotin before cystectomy and continued afterward for adults with resectable muscle-invasive bladder cancer. The decision extends a clinically validated PD-1 plus ADC regimen into an EU perioperative…
A specialized Dutch court found that Merck’s subcutaneous pembrolizumab product infringes Halozyme’s MDASE patent EP 2,797,622 and ordered MSD BV to stop specified manufacturing, distribution, marketing, use, import, and stocking activities tied to Keytruda…
Merck acquired exclusive worldwide development, manufacturing and commercialization rights to SPR2015 from Shanghai-based SciBrunch Therapeutics. Merck will pay $400 million upfront; total potential consideration, including the upfront, is $2.13 billion. The transaction has closed….
Daiichi Sankyo and Merck voluntarily withdrew the U.S. accelerated-approval application for ifinatamab deruxtecan in previously treated extensive-stage small-cell lung cancer after FDA discussions concluded that the supporting data, including Phase 2 IDeate-Lung01, did not…
FDA approved oral belzutifan plus lenvatinib for advanced clear-cell RCC after PD-1 or PD-L1 therapy. In the 747-patient randomized Phase 3 LITESPARK-011 study, the combination reduced the risk of progression or death by 26%…
Both remigromig doses met the Week 52 noninferiority endpoint versus ranibizumab for change in best-corrected visual acuity in the 984-participant BRUNELLO trial. Merck also disclosed higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and…
Merck and Moderna reported that the randomized Phase III INTerpath-001 trial met its primary recurrence-free-survival (RFS) endpoint and key secondary distant-metastasis-free-survival (DMFS) endpoint at a prespecified interim analysis. The study compares individualized neoantigen therapy…
