Roche Announces Positive Phase III INAVO120 Trial Results for Inavolisib in PIK3CA-Mutated HR+/HER2- Advanced Breast Cancer

Dec 06, 2023 07:53 CST Updated 07:53

Roche

Oncology Drug Research, Development, and Manufacturing

On December 5, Roche announced that inavolisib in combination with palbociclib（Ibrance) and fulvestrant as first-line treatmentPIK3CAMutation, Hormone Receptor（HR) positive, HER2 negative, endocrine-resistant, locally advanced or metastatic breast cancer patients in the Phase III INAVO120 study achieved positive results.The study met the primary endpoint of progression-free survival (PFS), with the inavolisib combination therapy group showing a statistically significant and clinically meaningful extension in PFS compared to palbociclib and fulvestrant alone. Overall survival (OS) data is not yet mature, but a clear positive trend has been observed, and subsequent analysis will continue.

PIK3CA gene mutations can lead to PI3Kα protein mutations, thereby promoting tumor growth.Out of Control, disease progression and resistance to endocrine therapy.InavoLisib is aOral, Highly SelectivePI3Kα inhibitor, and is able to specifically trigger the degradation of mutant PI3Kα protein.With this unique dual mechanism of action, inavolisib may provide a new option for HRPositive/HER2Negative,PI3KαPatients with mutant advanced breast cancer provide well-tolerated, durable disease control and may improveGood prognosis.

Inavolisib is currently undergoing three Phase III clinical trials:

INAVO121 Study: Combination with Fulvestrant vs.Apyrase CombinationFulvestrant is used in patients who have previously received CDK4/6 inhibitors and endocrine combination therapy for HR-positive/HER2-negative breast cancer patients.
INAVO122Research: Combination of Pertuzumab and Trastuzumab Subcutaneous Injection (Phesgo) vs. Phesgo as First-Line Maintenance Therapy for HER2-Positive Breast Cancer Patients.

Roche'sInavOlisib Achieves Positive Results in Phase III StudyLong-Awaited Good News for PI3K Inhibitors. In the past two years, there have been continuous reports about the withdrawal of drugs targeting this point from the market.

In mid-November, Bayer announcedWithdraw PI3Kα/δ inhibitor copanlisib (Aliqopa) from the U.S. market, the reason being that the post-marketing study (CHRONOS-4) failed to confirm copanlisibClinical Benefits。

Gilead's Idelalisib was once due toSafety IssuesAnd was withdrawn from the market;Similarly, due to safety concerns,SecuraVoluntary Withdrawal in the United StatesCopiktraIndication for the treatment of patients with relapsed or refractory follicular lymphoma (FL).

TG Therapeutics'Umbralisib was withdrawn from the market due to lack of significant clinical benefit;Besides, Incyte withdrew its marketing application for PI3Kδ inhibitor parsaclisib in the treatment of FL, marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) in January 2022. However, the reason was not related to efficacy or safety.

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