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Merck’s sac-TMT gains FDA priority review as endometrial-cancer survival data emerge

Merck ($MRK) disclosed detailed results from the global Phase 3 TroFuse-005 trial and said the FDA accepted sacituzumab tirumotecan for priority review. In 776 patients with advanced or recurrent endometrial cancer previously treated with platinum chemotherapy and immunotherapy, median overall survival reached 19.0 months versus 12.1 months with chemotherapy. The hazard of death fell 32%; median progression-free survival was 7.2 versus 3.9 months. The experimental drug, developed with Kelun-Biot

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Keytruda alone delays endometrial-cancer progression, but survival benefit remains unproven

Merck ($MRK) presented the first detailed Phase 3 KEYNOTE-C93 results for Keytruda alone in first-line advanced or recurrent mismatch repair-deficient endometrial cancer. Among 299 randomized patients, median progression-free survival reached 38.2 months versus 8.4 months with carboplatin and paclitaxel. The progression-or-death hazard fell 43%, meeting one of the trial’s two primary endpoints. The other primary endpoint, overall survival, did not show a statistically significant improvement at

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Merck and Moderna disclose detailed melanoma vaccine benefit in pivotal trial

Merck ($MRK) and Moderna ($MRNA) released detailed Phase 3 findings showing that their individualized cancer vaccine, intismeran autogene, improved outcomes when added to Keytruda after melanoma surgery. In INTerpath-001, involving 1,137 patients with completely removed stage IIB–IV disease, the combination reduced the risk of recurrence or death by 42% relative to Keytruda alone. At two years, recurrence-free survival was 82.2%, compared with 70.0%. The results also showed a 38% reduction in th

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Merck licenses preclinical cancer drug for $400 million upfront

Merck ($MRK) has completed an exclusive worldwide licensing agreement with SciBrunch Therapeutics for SPR2015, an experimental oral inhibitor targeting the active form of KRAS G12D. Merck gains development, manufacturing and commercialization rights. The transaction requires $400 million upfront, while its aggregate potential value, including that payment, reaches $2.13 billion if development and commercial milestones are achieved across multiple indications. The agreement adds a preclinical mol

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Merck wins FDA approval for Welireg–Lenvima kidney-cancer combination

Merck ($MRK) received FDA approval for Welireg plus Lenvima as an oral treatment for adults with advanced clear-cell renal cell carcinoma after a PD-1 or PD-L1 inhibitor. The decision adds a treatment option for patients whose kidney cancer has progressed following immunotherapy and is supported by the Phase 3 LITESPARK-011 trial. Among 747 participants, median progression-free survival was 14.6 months with the combination versus 10.6 months with cabozantinib, corresponding to a 26% lower hazard

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Merck’s Keytruda–Padcev regimen advances toward broader European use

Merck ($MRK) received a positive European advisory opinion for Keytruda combined with Padcev before and after radical cystectomy in adults with resectable muscle-invasive bladder cancer. The recommendation also covers subcutaneous Keytruda. It would broaden the existing European indication beyond patients unable to receive cisplatin-based chemotherapy, but still requires a European Commission decision. The supporting KEYNOTE-B15 study enrolled cisplatin-eligible patients and showed a 47% reducti

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