Roche's PI3Kα Inhibitor Inavolisib Granted Priority Review in China for PIK3CA-Mutated HR+/HER2- Advanced Breast Cancer

Apr 09, 2024 08:03 CST Updated 08:03

Roche

Oncology Drug Research, Development, and Manufacturing

▎WuXi AppTec Content Team Report

On April 8, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Roche had submitted an application.GDC-0077（inavolisib) Proposed for priority review, for the indication of: in combination with palbociclib and endocrine therapy for the treatment ofPIK3CAPatients with mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Public information shows that inavolisib is aSelective inhibitor targeting PI3Kα mutants.Regarding the indications proposed for priority review this time,Inavolisib was included in the breakthrough therapy category by the CDE in March this year.

Screenshot source:CDE Official Website

Public information shows,PIK3CAGene MutationFound in approximately 40% of HR-positive breast cancers, leading to uncontrolled tumor growth, disease progression, and resistance to endocrine therapy.

Inavolisib is aWith Dual Mechanisms of ActionAn oral therapy with high in vitro PI3Kα inhibition potency and selectivity, capable of specifically triggering the degradation of PI3Kα protein mutants.Through this unique dual mechanism of action, inavolisib may provide a new treatment option for HR-positive/HER2-negative,PIK3CAPatients with advanced breast cancer mutations receive well-tolerated, durable disease control and potentially improved outcomes.

In December 2023, Roche announced the combination of inavolisib with the CDK4/6 inhibitor palbociclib and fulvestrant (endocrine therapy),First-line TreatmentPositive Results from Phase 3 Clinical Trial (INAVO120) in Patients with Locally Advanced or Metastatic Breast Cancer.Patients participating in this clinical trialCarryPIK3CAMutation, HR-positive, HER2-negative tumors, and resistance to endocrine therapy。

The test results showed that, compared withPalbociclibCompared with the control group used in combination with fulvestrant,Inavolisib Combination Therapy GroupProgression-Free Survival (PFS) was 15.0 months (7.3 months in the control group), more than doubling the PFS,Reduced the risk of disease progression or death by 57%。This benefit was consistent across different subgroups. Although the overall survival (OS) data are not yet mature, a clear positive trend has been observed. The current data also show clinically significant improvements in objective response rate, duration of response, and clinical benefit rate.

▲Clinical trial results of Inavolisib for breast cancer (Image source: Reference [2])

According to Roche's recently released 2023 annual report, the company plans to submit these results to regulatory authorities in the hope of...PIK3CAA Potential New Treatment Option for Patients with HR+ Breast Cancer Mutations.

According to the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform, Roche has already launched the Chinese portion of the INAVO120 study in China. This study targets patients who experienced disease progression during adjuvant endocrine therapy or within 12 months after completing the therapy, and who previously received treatment for locally advanced or metastatic disease.Without systematic treatmentPIK3CAPatients with mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer.

References:

[1] Website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China. Retrieved Apr 8, 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Rche Reporting，Retrieved Feb 2, 2024 from https://assets.roche.com/f/176343/x/ac48d3ba3b/irp240201-a.pdf

[3] Roche’s inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation. Retrieved December 8, 2023, from https://www.roche.com/media/releases/med-cor-2023-12-08

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