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Summit Therapeutics Initiates P-II/III (HARMONi-GU1) Trial of Ivonescimab + Enfortumab Vedotin in Bladder Cancer

Shots: Summit has initiated P-II/III (HARMONi-GU1) trial of ivonescimab + enfortumab vedotin (EV) against Keytruda + EV as first-line treatment of locally advanced or metastatic urothelial (bladder) cancer The global, multi-regional trial will enroll ~800 pts through P-III, with site activations beginning later this year. P-II will determine the recommended P-III dose of ivonescimab in…

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Top 20 R&D Spending Biopharma Companies of 2026 

Top 20 R&D Spending Biopharma Companies of 2026  Shots:   Merck & Co., Roche, and Johnson & Johnson emerged as the leading pharmaceutical companies by R&D expenditure in 2025, investing $15.78B, $15.49B, and $14.66B, respectively. Continued investments in late-stage clinical programs, pipeline expansion, advanced technologies, and strategic business development reinforced their commitment to driving pharmaceutical innovation …

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Kelun Biotech

Kelun-Biotech Reports P-III Trial Findings on sac-TMT + Keytruda for 1L PD-L1-Negative Non-Squamous NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung06) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs CT + Keytruda as the 1L treatment for PD-L1-negative locally advanced or metastatic non-squamous NSCLC (TPS <1%) IDMC has concluded that the trial met its 1EP of improved PFS at interim analysis vs Keytruda + pemetrexed & Pt-based CT, plus…

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Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

Shots: The US FDA has approved Padcev (enfortumab vedotin) + Keytruda/Keytruda Qlex for neoadj. & adj. treatment for pts with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility Approval was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC…

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Merck

Merck Receives EC Approval for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: The EC has approved Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC across all 30 EEA states Approval was based on the P-III (KEYNOTE-905/EV-303) trial, which randomized cisplatin-ineligible MIBC pts to Arm A (neoadj. & adj. Keytruda), Arm B (surgery alone), or Arm C (neoadj. & adj. Keytruda + Padcev)…

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Merck new

Merck Reports FDA Approval of Keytruda/Keytruda QLEX + Welireg in Clear Cell Renal Cell Carcinoma

Shots: The US FDA has approved MSD's Welireg + Keytruda/Keytruda QLEX as adj. therapy in clear cell renal cell carcinoma (ccRCC) pts at intermediate-high or high risk of recurrencepost-nephrectomy or post-nephrectomy & resection of metastatic lesions Approval was backed by the P-III (LITESPARK-022) trial data assessing Keytruda (400mg, Q6W, IV) + Welireg (120mg, QD, PO)…

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Henlius Reports First US Patient Dosed in Global P-I Trial of HLX17 (Biosimilar, Keytruda) 

Shots:  Shanghai Henlius has dosed the first US patient in the global P-I trial of HLX17, a biosimilar version of Keytruda (pembrolizumab), for the adjuvant treatment of multiple resected solid tumors  P-I multicentre study evaluates the PK, efficacy, safety, and immunogenicity of HLX17 vs Keytruda in pts with resected solid tumors, including non-small cell lung cancer, melanoma, and renal cell carcinoma.…

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