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Merck

Merck Reports P-III (KEYNOTE-689) Trial Data of Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma

Shots: The P-III (KEYNOTE-689) trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (× 15 cycles) + SoC radiotherapy (RT) ± cisplatin vs adj. SoC RT without cisplatin in treatment-naïve pts (n=714) with stage III/IVA resected LA-HNSCC; sBLA under the FDA’s review (PDUFA: Jun 23, 2025) At 38.3 mos. mFU,…

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Akesobio

Akeso’s Penpulimab-kcqx Receives the US FDA’s Approval for Nasopharyngeal Carcinoma (NPC)

Shots: The US FDA has approved penpulimab-kcqx + CT (cisplatin/carboplatin + gemcitabine) as 1L treatment for recurrent or metastatic non-keratinizing NPC in adults, & as monotx. for those with metastatic non-keratinizing NPC progressing on/after Pt-based CT & ≥1L prior therapy Approval was supported by 2 BLA submissions based on international P-III (AK105-304) trial & pivotal…

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Accent Theraoeutics

Accent Therapeutics to Highlight Preclinical Data of ATX-559 and ATX-295 at AACR 2025

Shots: Accent Therapeutics to present preclinical data of ATX-559 (DHX9 inhibitor) & ATX-295 (KIF18A inhibitor) at AACR 2025 Presentation will highlight ATX-559’s activity in cancers exhibiting genomic instability & replication stress in in vivo models, incl. dMMR/MSI-H colorectal & BRCA-altered triple-negative breast cancer, plus ATX-295’s activity in ovarian cancer & its relation with whole genome…

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