Novarca Piqray Treatment of PIK3CA Mutation HR-/HER2-Breast Cancer: Significantly Extended Lifetime.

The data presented at the ESMO conference provide more and more evidence of efficacy in Piqray's treatment of aBC patients with PIK3CA mutations.
, 334,000 people are diagnosed with advanced breast cancer (aBC) each year.
about 40% of patients with the HR plus/HER2-subtype have APK3CA mutation, which stimulates tumor growth and is associated with poor treatment response and poor prognostication.
alpelisib chemical structure (Photo: selleckchem.com) Piqray is a α sexual PI3K kinase inhibitor that was approved by the United States in May 2019, 2 Approved by the European Union in July 2020 for the treatment of post-menoanthetic female and male breast cancer patients, specifically: progression of the disease after endocrine therapy treatment, carrier PIC3CA mutation, HR plus/HER2-local advanced or metastatic breast cancer patients.
Piqray is the first and only treatment specifically approved for the treatment of patients with advanced breast cancer who carry the PIC3CA mutation in their tumors.
, the drug has been approved in 48 countries.
the drug's launch will change the treatment pattern for patients with HR-/HER2-advanced breast cancer who carry the PIC3CA mutation, providing clinicians with a clear treatment.
SOLAR-1 is a randomized, double-blind, placebo-controlled Phase III study that assessed the efficacy and safety of PIC3CA mutations, HR-/HER2-advanced or metastasis breast cancer in post-menophageal female and male patients who developed the condition during or after treatment with aromatase inhibitors (combined with or without a CDK4/6 inhibitor).
previously released data showed that Piqray-fluvis group therapy significantly doubled the progression-free lifetime (medium PFS: 11.0 months vs 5.7 months), significantly reduced the risk of disease progression or death by 35 per cent compared to fluovis groups (HR-0.65, 95% CI: 0.50-0.85; p<0.001), total mitigation rate (ORR) more than doubled (36% vs 16%).
analysis of the PFS subgroup showed that Piqray's efficacy was consistent with regardless of lung/liver metastasis.
in non-mutant patients with PIC3CA, the PFS improvement effect of Piqray-fluovis group drugs was not significant.
released at the ESMO meeting showed that there was an 8-month clinically-related improvement in the total survival (OS) of the Piqray-Fluvis group treatment group compared to the fluorovis group treatment group (mid 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 does not reach the statistically significant threshold.
OS improvement in patients with pulmonary or liver metastasis improved by more than 14 months, which meant more serious diseases (medium OS: 37.2 months vs 22.8 months; HR: 0.68; 95% CI: 0.46-1.00).
addition, the data showed that patients in the Piqray-Fluvis group needed chemotherapy for nine months (23.3 months vs 14.8 months; HR=0.72; 95% CI:0.54-0.95) compared to the fluorovis group, maintaining a quality of life (QOL).
security, no new safety signals were observed and adverse events were consistent with previously reported results.
original source: Novartis Piqray® data show survival benefit for patients with HR plus/HER2- advanced breast cancer with a PIK3CA mutation.