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Phase 2 Trial Highlights Potential of Inavolisib for PIK3CA-Mutated Cancers

Inavolisib (GDC-0077) showed a favorable safety profile and disease control rates of 60% at week 8 and 32% at week 16 in patients with refractory, PIK3CA-mutated solid tumors, according to the phase 2 CRAFT trial. The median progression-free survival was 3.52 months, and the 12-month overall survival rate was 51%. The most common PIK3CA mutations were E545K, E542K, and H1047R/L, with 7 patients achieving disease control at week 16. Adverse effects included hyperglycemia, diarrhea, fatigue, and constipation, mostly at grade 1 or 2.


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Phase 2 Trial Highlights Potential of Inavolisib for PIK3CA-Mutated Cancers

Inavolisib (GDC-0077) showed a favorable safety profile and disease control rates of 60% at week 8 and 32% at week 16 in patients with refractory, PIK3CA-mutated solid tumors, according to the phase 2 CRAFT trial. The median progression-free survival was 3.52 months, and the 12-month overall survival rate was 51%. The most common PIK3CA mutations were E545K, E542K, and H1047R/L, with 7 patients achieving disease control at week 16. Adverse effects included hyperglycemia, diarrhea, fatigue, and constipation, mostly at grade 1 or 2.

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