Roche Announces China Approval of Breakthrough Breast Cancer Drug Inavolisib

Mar 14, 2025 10:38 CST Updated 10:38

Roche

Oncology Drug Research, Development, and Manufacturing

▎WuXi AppTec Content Team Report

Today (March 14),Roche just announcedInavolisib Tablets Approved for Marketing in China, Combined with Palbociclib and Fulvestrant, for Adult Patients with Locally Advanced or Metastatic Breast Cancer who are Endocrine Therapy-Resistant (Including Recurrence During or After Adjuvant Endocrine Therapy), PIK3CA-Mutated, Hormone Receptor (HR)-Positive, and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative。Public information shows that Inavolisib (GDC-0077) is aSelective Inhibitors Targeting PI3Kα Mutants。

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

InariseIs aAn oral therapy with a dual mechanism of action, demonstrating high potency and selectivity in inhibiting PI3Kα in vitro, and capable of specifically triggering the degradation of mutant PI3Kα proteins.Through this unique dual mechanism of action, inavolisib may offer well-tolerated, durable disease control and potentially improved outcomes for patients with HR-positive/HER2-negative, PIK3CA-mutated advanced breast cancer. Regarding the approved indication this time,InariseThe combination therapy consisting of the CDK4/6 inhibitor palbociclib and fulvestrant was granted Breakthrough Therapy designation by the FDA in the United States and included as a breakthrough treatment by the NMPA in China.

October 2024, U.S. FDAApprovalInaribine TabletsWith CDK4/6 InhibitorsPalbociclib(Palbociclib) in combination with fulvestrant for the treatment of tumors carryingPIK3CAMutations, endocrine therapy resistance, HR-positive, HER2-negative locally advanced or metastatic breast cancer in adult patients whose disease recurs during or after adjuvant endocrine therapy.

According to the Roche press release, the approval of Inavolisib was based on the INAVO120 study, a global, multicenter, double-blind, randomized controlled Phase III clinical trial. This study aimed to evaluate the efficacy and safety of Inavolisib + Palbociclib + Fulvestrant as a first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer patients with PIK3CA mutations. In the INAVO120 study, the novel PI3Kα inhibitor Inavolisib, combined with a CDK4/6 inhibitor and endocrine therapy drugs, demonstrated excellent clinical outcomes.Inavolisib significantly prolonged median PFS (15.0 vs. 7.3 months) and reduced the risk of disease progression or death by 57%, offering a more specific treatment option for HR+/HER2- advanced breast cancer patients with PIK3CA mutations., while overcoming the obstacle of target toxicity, ensuring the safety of patients during treatment.The research results have been previously published inThe results were published in The New England Journal of Medicine (NEJM）。

References:

[1] 38 Years of R&D Breakthrough! Roche Receives Approval for China’s First Targeted Innovative Drug for PIK3CA Mutation, Bringing New Hope to Breast Cancer Patients. From https://mp.weixin.qq.com/s/8wLU4pO8TKhERpoEXLT4Xg

[2] FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer. Retrieved October 10, 2024, from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-inavolisib-palbociclib-and-fulvestrant-endocrine-resistant-pik3ca-mutated-hr-positive

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

[4] Heavyweight! Roche's Inavolisib Granted Priority Review in China for the Treatment of PIK3CA-Mutated HR-Positive/HER2-Negative Breast Cancer，Retrieved Apr 16, 2024, from https://mp.weixin.qq.com/s/yKj4ejQfnJRL0AeVd9-Wjw

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