Inavolisib
- Generic Name
- Inavolisib
- Brand Names
- -
- Drug Type
- Small Molecule
- Chemical Formula
- C18H19F2N5O4
- CAS Number
- 2060571-02-8
- Unique Ingredient Identifier
- L4C1UY2NYH
- Background
Inavolisib (GDC-0077) is under investigation in clinical trial NCT03006172 (To Evaluate the Safety, Tolerability, and Pharmacokinetics of GDC-0077 Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer).
- Associated Conditions
- -
- Associated Therapies
- -
Inavolisib Shows Promising Disease Control Rates, Safety in Patients With PIK3CA-Mutated
CRAFT interim analysis shows inavolisib (GDC-0077) promising in disease control for rare tumors, with 36% disease control rate in PIK3CA-mutated tumors. Presented at ESMO 2024, ongoing CRAFT trial aims to confirm efficacy and safety across various disease states.
Related Clinical Trials:
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.
Related Clinical Trials:
FDA Grants Priority Review to Roche’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
FDA grants Priority Review to Roche's inavolisib for advanced HR+/HER2- breast cancer with PIK3CA mutation, based on Phase III INAVO120 results showing significant progression-free survival benefits.
Related Clinical Trials:
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