Inavolisib

RLY-2608, an oral, mutant-selective PI3Kα allosteric inhibitor, addresses off-target toxicities of existing modulators like alpelisib and inavolisib. It is in Phase I for HR+/HER2- breast cancer treatment with fulvestrant.

FDA approves inavolisib plus palbociclib/fulvestrant for endocrine-resistant, PIK3CA-mutated, HR+/HER2– advanced breast cancer; perioperative pembrolizumab improves event-free survival in resected stage III/IVA HNSCC; 2023 cisplatin shortage led to chemotherapy alternatives and cost increases; Yuan Yuan discusses ADC and CDK4/6 inhibitor sequencing in breast cancer; talazoparib plus enzalutamide improves OS in mCRPC.

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The FDA approved inavolisib plus palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR+/HER2- breast cancer, based on INAVO120 trial data showing improved median PFS (15.0 months vs. 7.3 months). This marks a significant milestone, offering a new therapeutic approach for patients with high-risk early progression and manageable toxicity.

RMC-9805, a covalent KRAS(G12D)(ON) molecular glue inhibitor, employs a CypA-recruiting tricomplex mechanism and an aziridine covalent handle to target the 'undruggable' KRAS(G12D) mutant. Structural and modeling insights were crucial for engaging the mutant Asp, and RMC-9805 synergizes with PD-1 inhibitors, showing clinical progress.

FDA approves Genentech's Itovebi (inavolisib) for HR+/HER2- breast cancer with PIK3CA mutation, in combo with Ibrance and fulvestrant. FoundationOneLiquid CDx is approved as a companion diagnostic. Itovebi aims to reduce toxicity of other PI3K inhibitors, with a 28-day cycle costing $22,867. Phase 3 INAVO120 data showed Itovebi regimen doubled progression-free survival vs. Ibrance and fulvestrant alone, reducing risk of disease worsening or death by 57%.

FDA approved inavolisib (PI3K inhibitor) with palbociclib and fulvestrant for HR-positive, HER2-negative, PIK3CA-mutated breast cancer. Efficacy shown in trial NCT04191499 with median progression-free survival of 15.0 months vs 7.3 months with placebo. Common adverse reactions include decreased neutrophils, hemoglobin, and platelets, and increased fasting glucose. Inavolisib dose is 9 mg orally daily.

FDA approves inavolisib for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer, based on Phase 3 INAVO120 study showing improved progression-free survival and objective response rate.

Roche’s PI3K inhibitor Itovebi (inavolisib) approved by FDA for advanced breast cancer in combination with Pfizer’s Ibrance and fulvestrant. INAVO120 study showed 57% reduction in disease worsening or death risk. Itovebi to be available in the US soon, with submissions to other global health authorities ongoing.