Novartis’ Piqray Demonstrates Clinically Meaningful Survival Benefit in PIK3CA-Mutated HR+/HER2- Advanced Breast Cancer

September 20, 2020 News /BioValleyBIOON/ --Novartis(Novartis) recently at the 2020 European MedicalTumorpresented at the virtual congress of the European Society for Medical Oncology (ESMO)Breast CancerFinal overall survival (OS) analysis results from the Phase III SOLAR-1 study of the novel drug Piqray (alpelisib). The data showed that, in patients with PIK3CA-mutated, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (aBC), compared with the fulvestrant treatment group,The Piqray + fulvestrant combination therapy group demonstrated a clinically relevant 8-month improvement in OS, with OS improvements exceeding 14 months in patients with lung or liver metastases.Hepatic and pulmonary metastases were observed in 41% of postmenopausal women with HR+ advanced breast cancer (aBC) and are considered more aggressive and more challenging to treat.

The data presented at this ESMO congress provides growing evidence of the efficacy of Piqray in treating patients with PIK3CA-mutated advanced breast cancer (aBC). Globally, 334,000 people are diagnosed each yearDiagnosisfor advanced breast cancer (aBC). Approximately 40% of patients with the HR+/HER2- subtype harbor PIK3CA mutations, which stimulateTumorgrowth, and is associated with poor response to treatment and a very poor prognosis.

Chemical Structure of Alpelisib (Image Source: selleckchem.com)

Piqray is an alpha-specific PI3K kinase inhibitor that received US approval in May 2019 and EU approval in July 2020 for the treatment of postmenopausal women and men with breast cancer, specifically those with HR+/HER2- locally advanced or metastatic breast cancer who have experienced disease progression following endocrine therapy and harbor PIK3CA mutations.

Piqray is the first and only therapy specifically approved for the treatment of patients with advanced breast cancer whose tumors harbor PIK3CA mutations. To date, the drug has been approved in 48 countries. The launch of this drug will changeTumorTreatment Landscape for Patients with HR+/HER2- Advanced Breast Cancer Harboring PIK3CA Mutations: Providing Clinicians with a Clear Therapeutic Approach

SOLAR-1 was a randomized, double-blind, placebo-controlled Phase III study 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), to evaluate the efficacy and safety of Piqray in combination with fulvestrant.

Previously published data demonstrated that, compared with fulvestrant monotherapy, treatment with Piqray plus fulvestrant significantly doubled progression-free survival (median PFS: 11.0 months vs. 5.7 months), reduced the risk of disease progression or death by 35% (HR=0.65, 95% CI: 0.50–0.85; p<0.001), and more than doubled the overall response rate (ORR) (36% vs. 16%). Subgroup analysis of PFS showed consistent efficacy of Piqray regardless of the presence of lung or liver metastases. In patients without PIK3CA mutations, the improvement in PFS with the combination of Piqray and fulvestrant was not significant.

Data presented at this ESMO congress showed that, compared with the fulvestrant monotherapy group, the Piqray plus fulvestrant group demonstrated a clinically relevant 8-month improvement in overall survival (OS) (median OS: 39.3 months vs. 31.4 months; one-sided p≤0.0161; HR=0.86; 95% CI: 0.64–1.15; p=0.15). This difference did not reach the threshold for statistical significance. In patients with lung or liver metastases, the OS improvement exceeded 14 months, indicating a greater benefit in those with more severe disease (median OS: 37.2 months vs. 22.8 months; HR=0.68; 95% CI: 0.46–1.00).

Furthermore, data showed that compared with the fulvestrant treatment group, patients in the Piqray plus fulvestrant treatment group had a 9-month delay in time to chemotherapy (23.3 months vs. 14.8 months; HR=0.72; 95% CI: 0.54–0.95) and maintained quality of life (QOL).

In terms of safety, no new safety signals were observed, and adverse events were consistent with previously reported results. (Bioon.com)

Original Source: Novartis Piqray® data show survival benefit for patients with HR+/HER2- advanced breast cancer with a PIK3CA mutation