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Kelun Biotech
NEWS

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…
July 15, 2026

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NEWS

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…
July 13, 2026

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Merck
NEWS

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)…
June 24, 2026

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NEWS

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)…
June 15, 2026

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NEWS

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.…
June 5, 2026

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NEWS

OSE Immunotherapeutics Reports P-II (TEDOVA) Trial Data on Tedopi Combination in Recurrent Ovarian Cancer

Shots: OSE Immunotherapeutics has reported the topline P-II (TEDOVA/GINECO-OV244b/ENGOT-ov58) trial results evaluating Tedopi (OSE2101) ± Keytruda as a maintenance treatment in pts with Pt-sensitive recurrent ovarian cancer (PSOC)  Trial enrolled 185 pts with PSOC who progressed after or were ineligible for PARP inhibitors & Avastin. Pts achieving CR, PR, or stable disease after Pt-based therapy…
May 25, 2026

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NEWS

Astellas Receives CHMP Positive Opinion for Perioperative Padcev + Keytruda for Muscle-Invasive Bladder Cancer (MIBC)

Shots: The CHMP has recommended Astellas' Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for cisplatin-ineligible pts with resectable MIBC; If approved, authorization would be valid in all 30 EEA states Opinion 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…
May 22, 2026

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