An interim analysis from the CRAFT trial indicates that inavolisib (GDC-0077) shows promising disease control rates in patients with rare tumors, according to data presented at the European Society of Medical Oncology (ESMO) 2024 Congress in Barcelona. The CRAFT trial, an ongoing phase 2 clinical study, investigates molecularly targeted agents and PD-L1 inhibition across seven different cancer types with specific genetic mutations. told by Pharmacy Times.
Focusing on arm 5 of the trial, which includes patients with PIK3CA-mutated tumors, 14 patients in stage 1 showed a 36% disease control rate at day 110, leading to further recruitment for stage 2. Toxicity, such as hyperglycemia, was noted, but 10 patients demonstrated disease control, and 7 remain under treatment awaiting further evaluation.
The trial is exploring multiple outcomes, including progression-free survival (PFS) and overall survival, with a median follow-up of 24 months planned. The results suggest inavolisib’s potential in treating rare tumors and its ongoing investigation in breast cancer, with the FDA granting priority review for its use in hormone receptor-positive, HER2-negative breast cancer patients with PIK3CA mutations. report from NIH.
Further research will be needed to confirm inavolisib’s efficacy and safety across other cancers.
