Novartis Receives EU Approval for PI3K Inhibitor Piqray in PIK3CA-Mutated Advanced Breast Cancer
Novartis
Drug Development and Manufacturing
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Compiled by S. Li
On July 29, local time, Novartis announced that the European Commission (EC) has approved Piqray (alpelisib) in combination with fulvestrant for postmenopausal women and men with breast cancer. These patients have hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) disease that has progressed following prior endocrine therapy, harbor a PIK3CA mutation, and present with locally advanced or metastatic disease. Piqray is the first and currently only approved medication specifically indicated for patients with PIK3CA-mutated breast cancer.
This approval is based on the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on this application in late May of this year. The affirmative assessments by both the CHMP and the European Commission (EC) were based on the results of the Phase III clinical trial SOLAR-1. This study was a randomized, double-blind, placebo-controlled trial conducted in postmenopausal women and men with PIK3CA-mutated, HR+/HER2- advanced or metastatic breast cancer who had experienced disease progression during or after treatment with an aromatase inhibitor (with or without a CDK4/6 inhibitor). The study evaluated the efficacy and safety of Piqray in combination with fulvestrant. A total of 572 patients were enrolled and randomized in a 1:1 ratio to receive either Piqray (300 mg once daily) plus fulvestrant (500 mg per 28-day cycle, with an additional loading dose on Day 15 of Cycle 1) or placebo plus fulvestrant.
The results showed that, compared with the fulvestrant group, Piqray in combination with fulvestrant nearly doubled the median progression-free survival (PFS) (11.0 months vs. 5.7 months), significantly reduced the risk of death by 35% (HR=0.65, 95% CI: 0.50–0.85; p<0.001), and more than doubled the overall response rate (36% vs. 16%). Most adverse events in the study were mild to moderate in severity and were generally manageable through dose adjustments and medical management.
Relevant data indicate that 70% of breast cancer patients are hormone receptor-positive and HER2-negative (HR+/HER2-), with approximately 40% of these patients harboring activating PIK3CA mutations. Piqray is an oral, small-molecule, alpha-specific PI3K inhibitor that suppresses tumor cell proliferation by inhibiting the PI3K signaling pathway. Patients prescribed Piqray must undergo genetic testing of tumor tissue or plasma samples to confirm the presence of a PIK3CA mutation. If plasma testing does not detect the mutation, further testing of tumor tissue should be conducted, if feasible, to confirm its status. The drug was approved by the U.S. FDA in May 2019, becoming the first PI3Kα inhibitor approved by the FDA for the treatment of breast cancer.
In China, on April 27 this year, alpelisib was approved for clinical use in combination with fulvestrant for the treatment of postmenopausal women and male patients with hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer who have experienced disease progression during or after endocrine therapy.
Currently, two PI3Kα inhibitors have been approved globally; the other is Bayer’s copanlisib, which was approved in 2017 for the treatment of follicular lymphoma.
Reference source: Novartis receives Piqray® approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.