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Akesobio
NEWS

Akeso Reports First Patient Dosing in P-III (COMPASSION-33) Trial of Cadonilimab for G/GEJ Adenocarcinoma

Shots: Akeso has enrolled & dosed its first patient with cadonilimab (PD-1/CTLA-4 BsAb) + CT in P-III (AK104-310/COMPASSION-33) trial for the perioperative treatment of resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma The P-III (COMPASSION-33) trial in resectable G/GEJ adenocarcinoma pts is designed to improve radical resection rates, lower recurrence & metastasis risk, & improve patient outcomes Additionally,…
August 20, 2025

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NEWS

Health Canada Grants Conditional Approval to Iovance’s Amtagvi (Lifileucel) for Advanced Melanoma

Shots: Health Canada has granted conditional approval (NOC/c) to Amtagvi for adults with unresectable or metastatic melanoma progressing after prior systemic therapy, incl. PD-1 inhibitor &, if BRAF V600 positive, then BRAF ± MEK inhibitor, with no suitable alternative options Approval was granted based on global P-II (C-144-01) trial assessing Amtagvi in above pts, which…
August 20, 2025

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Hutchmed
NEWS

HUTCHMED Completes Patient Enrolment in P-III (SANOVO) Trial of Orpathys (savolitinib) and Tagrisso (osimertinib) for EGFRm NSCLC

Shots: HUTCHMED has completed enrolment in its P-III (SANOVO) trial to assess Orpathys + Tagrisso as a 1L treatment of pts with locally advanced or metastatic NSCLC harboring EGFR mutation & MET overexpression; last patient was enrolled in Aug 18, 2025 Trial will evaluate Orpathys + Tagrisso vs Tagrisso in NSCLC pts, assessing PFS as 1EP,…
August 20, 2025

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NEWS

Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) Receives the EC’s Conditional Approval for MASH with Liver Fibrosis

Shots: The EC has granted conditional approval to Rezdiffra to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with mod. to adv. liver fibrosis in 30 EEA states; launch is planned throughout EU starting with Germany in Q4’25 Approval was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which…
August 20, 2025

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SpringWorks Therapeutics
NEWS

SpringWorks Therapeutics (Merck KGaA) Reports the EC’s Approval of Ogsiveo (Nirogacestat) for Desmoid Tumors

Shots: The EC has approved Ogsiveo as a monotx. for adults with progressing desmoid tumors needing systemic treatment Approval was based on global P-III (DeFi) trial (N=142) assessing Ogsiveo (150mg, BID, n=70) vs PBO (n=72) in adults with progressing desmoid tumors Trial met its 1EP with 71% reduction in risk of disease progression & showed…
August 19, 2025

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Merck new
NEWS

Merck Receives Health Canada’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: Health Canada has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC tumors expressing PD-L1 (CPS ≥1) Approval was based on P-III (KEYNOTE-689) trial assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ±…
August 14, 2025

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Remegen
NEWS

Remegen Reports P-III Trial Data of Telitacicept for Sjögren’s Syndrome in China

Shots: Remegen has reported P-III trial data assessing telitacicept vs PBO in pts with primary Sjögren's syndrome Trial met its 1EP of reduced EULAR Sjögren’s syndrome disease activity index (ESSDAI), showing improved disease activity at Wk. 24; NMPA’s BLA submission is planned, along with presentation of detailed data at an upcoming conference Telitacicept is a…
August 13, 2025

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