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Astellas starts Phase 3 trial of setidegrasib versus docetaxel in KRAS G12D — mutated NSCLC

Astellas dosed the first patient in a Phase 3 trial of setidegrasib for previously treated KRAS G12D-mutated advanced NSCLC. Study pits the investigational KRAS G12D protein degrader against docetaxel, targeting patients who progressed on platinum chemotherapy and CPI. Trial focuses on whether setidegrasib can delay disease worsening or extend survival versus chemotherapy, addressing a market with no approved KRAS G12D options. Early clinical results were already presented in March 2026 in The New England Journal of Medicine, showing antitumor activity with manageable safety. Astellas plans to enroll about 356 patients, marking its second Phase 3 start for setidegrasib within six months. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Astellas Pharma Inc. published the original content used to generate this news brief via (Ref. ID: CG55603) on September 23, 2026, and is solely responsible for the information contained therein

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Astellas dosed the first patient in a Phase 3 trial of setidegrasib for previously treated KRAS G12D-mutated advanced NSCLC. Study pits the investigational KRAS G12D protein degrader against docetaxel, targeting patients who progressed on platinum chemotherapy and CPI. Trial focuses on whether setidegrasib can delay disease worsening or extend survival versus chemotherapy, addressing a market with no approved KRAS G12D options. Early clinical results were already presented in March 2026 in The New England Journal of Medicine, showing antitumor activity with manageable safety.

Astellas plans to enroll about 356 patients, marking its second Phase 3 start for setidegrasib within six months. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Astellas Pharma Inc.

published the original content used to generate this news brief via (Ref. ID: CG55603) on September 23, 2026, and is solely responsible for the information contained therein. (C)