Novartis Announces Positive Phase 3 SOLAR-1 Trial Results for Alpelisib, the First α-Specific PI3K Inhibitor, in PIK3CA-Mutated HR+/HER2- Advanced Breast Cancer

August 23,NovartisNovartis announced that its global Phase 3 clinical trial, SOLAR-1, achieved positive results. In this study, the PI3Kα inhibitorBYL719 (alpelisib)ForPIK3CA-Mutated HR+/HER2- Breast CancerThe therapeutic trial met its primary endpoint, extending patients'Progression-Free Survival. The detailed research findings will be submitted to the upcoming medical conference.

SOLAR-1is a global Phase III randomized, double-blind, placebo-controlled trial that investigatedalpelisibCombined with FulvestrantEfficacy and Safety in the Treatment of PIK3CA-Mutated Advanced or Metastatic Breast Cancer in Postmenopausal Women and Men Who Have Received Aromatase Inhibitor Therapy (With or Without CDK4/6 Inhibitors)Types of progression. A total of 572 enrolled patients were randomized in a 1:1 ratio to receive either alpelisib (300 mg) plus fulvestrant (500 mg) or placebo plus fulvestrant. StudyIn China, the adverse events observed with alpelisib in combination with fulvestrant were generally consistent with those reported in previous studies. The SOLAR-1 trial will continue to evaluate secondary endpoint data. Novartis will initiate discussions with global health authorities based on these results.

Existing studies have confirmed that,PI3K PathwayIt plays a critical role in several processes essential for cancer progression, including cellular metabolism, growth, survival, and motility. Activation of the PI3K pathway in breast cancer is associated with resistance to endocrine therapy, disease progression, and poor prognosis.Proteins in the PI3K pathway consist of four smaller isoforms. Among them, approximately 40% of patients with advanced breast cancerα-Subtypegene mutations areActivate, known asPIK3CA Mutation. Mutations in the other three subtypes are generally not associated with advanced-stage breast cancer.Currently, there are no approved PI3K inhibitors globally forHR-Positive Advanced Breast CancerTreatment.

Alpelisibis an investigational oralα-specific PI3K inhibitor. In breast cancer cell lines harboring PIK3CA mutations, it has been demonstrated to inhibit the PI3K pathway and exhibit antiproliferative effects. Furthermore, cancer cells with PIK3CA mutations show greater sensitivity to this drug compared to those without mutations across various cancer types.

Molecular Structure of BYL719 (Alpelisib) (from Selleck Website)

Samit Hirawat, Global Head of Product Development for Novartis Oncology, stated: “BYL719 is the onlyα-Specific PI3K Inhibitor", it is also the first inhibitor shown to increase patient benefit and be tolerable for patients. We are encouraged by the results of the SOLAR-1 study and look forward to submitting these data to upcoming medical conferences."(Compiled by Sina Medicine / David)

Article reference source: SOLAR-1 trial of Novartis investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) meets primary endpoint in HR+/HER2- advanced breast cancer with PIK3CA mutation