What new results have Inavolisib achieved in clinical trials?

Inavolisib (Inavolisib) is a selective PI3Kα inhibitor. In recent years, it has made significant breakthroughs in the treatment of PIK3CA mutated HRpositive/HER2negative advanced breast cancer. inINAVO120 In phase III clinical trials, researchers combined Inavolisibpalbociclib with fulvestrantAs a first-line treatment, it significantly extended the patient's median progression-free survival (PFS) to 15 months, while the control group was only 7.3 months. This study confirms that the combination regimen can effectively delay disease progression and provides new treatment hope for patients with PIK3CA mutant breast cancer.

In terms of efficacy, the objective response rate (ORR) of the Inavolisib combination regimen reached 58.4%, which was almost twice that of the control group (25%), showing stronger tumor control capabilities. In addition, the combination therapy also shows the potential to delay the need for chemotherapy, with some studies indicating that it can delay chemotherapy for nearly two years, significantly improving patients' quality of life. This breakthrough not only enhances doctors' confidence in the intervention of mutant breast cancer, but also establishes a clearer clinical path for PI3K targeted therapy.

In terms of safety, although the adverse reactions of the combination regimen (such as neutropenia, hyperglycemia, etc.) have increased, the overall controllability is good. Study data showed that the treatment discontinuation rate was 6.8% and no new safety signals were observed. Most of the adverse events can be alleviated through dose adjustment and symptomatic treatment, indicating that this regimen has high tolerability in clinical application and provides guarantee for long-term medication.

With the announcement of these clinical results, the U.S. FDAFDA has granted Inavolisib "Breakthrough Therapy Designation" and initiated a priority review process to speed up its marketing process. At the same time, EU regulatory agencies also approved its combination treatment regimen for PIK3CA mutations in 2025HR+/HER2–Breast cancer patients. More importantly, inalise has also shown potential in other PIK3CA mutated solid tumors, indicating that it is expected to expand to more indications in the future.

Reference materials:https://www.drugs.com/