Benzinga | Dec 10, 2021 08:05AM EST

Novartis Highlights Efficacy Data Of Piqray Presented At 2021 San Antonio Breast Cancer Symposium

Novartis today announced new Piqray(r) (alpelisib) data indicating benefit across a broad range of patient and disease characteristics as seen in analyses from all three cohorts of BYLieve. BYLieve is an ongoing Phase II, open-label, 3-cohort non-comparative study evaluating Piqray with endocrine therapy including men and pre- and postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (mBC) who have progressed on or after prior therapies, including CDK4/6 inhibitor plus endocrine therapy1-5. These data will be presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) from December 7-10.

"The data from all three cohorts of the BYLieve study have value for the medical community and for the patients we care for with mBC, because these cohorts show a benefit from alpelisib in the post-CDK4/6i setting for patients with HR+/HER2- PIK3CA-mutated cancer," said Dr. Hope S. Rugo, Director, Breast Oncology and Clinical Trials Education, University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. "Beyond illustrating the efficacy and safety of alpelisib, regardless of the duration of prior CDK4/6i treatment, the data provide meaningful insights into how alpelisib may benefit different subgroups of patients."

Highlights from the BYLieve data presented at SABCS

* BYLieve Cohort A (P1-18-03): Updated safety and efficacy data after 18 months of follow-up showed median overall survival improvement of 26.4 months (95% CI: 21.0-30.5) for patients treated with Piqray plus fulvestrant immediately following CDK4/6i plus an AI1. The most common all-grade adverse events (AEs) (n=127) were diarrhea (63.8%), hyperglycemia (59.8%), nausea (46.5%) and rash (31.5%)1.

* BYLieve Cohort C (PD13-05): The third and final BYLieve cohort included patients who received chemotherapy or endocrine therapy as immediate prior treatment, who could have received prior CDK4/6i as well2. The primary endpoint was met with 48.7% (95% CI: 39.3%-58.2%) of patients alive and without disease progression at six months2. Data confirm clinically relevant activity of Piqray as a targeted therapy for PIK3CA as a driver oncogene2. No new safety signals were observed, with the most common all-grade AEs (n=126) being hyperglycemia (65.1%), diarrhea (52.4%), nausea (40.5%) and rash (38.9%)2.

* BYLieve Cohorts A & B (P1-18-08; P5-13-03; PD15-01): Exploratory biomarker and post-hoc analyses demonstrated efficacy with Piqray plus fulvestrant/letrozole in CDK4/6i-resistant mBC, as seen in patients with early discontinuation of the prior CDK4/6i (Cohort A: ?6 months median PFS of 12.0 months and >6 months median PFS of 6.2 months; HR=0.51; 95% CI: 0.29-0.89; Cohort B: ?6 months median PFS of 5.9 months and >6 months median PFS of 5.6 months; HR=0.72; 95% CI: 0.45-1.18), supporting the use of Piqray plus endocrine therapy as an immediate next-line option in these patients3. Grade ?3 AEs were experienced by 84.6% (n=22) and 66.0% (n=66) of patients in the ?6 months and >6 months subgroups, respectively, in Cohort A and by 62.5% (n=20) and 72.5% (n=66) of patients in the ?6 months and >6 months subgroups, respectively, in Cohort B3.

Additionally, the exploratory ctDNA analysis from Cohorts A and B (median PFS of 7.3 months and 5.7 months in Cohorts A and Cohort B, respectively) found that Piqray was effective in the post-CDK4/6i setting regardless of endocrine therapy partner and tumor genomic profile and other mutations associated with CDK4/6i resistance4. Across the three cohorts no new safety signals were observed, even with longer exposure, as seen in Cohort A, confirming no cumulative toxicities with Piqray1-3.

An estimated 361,826 people are diagnosed with mBC worldwide each year, and approximately 40% of those with HR+/HER2- subtype have a PIK3CA mutation, which is associated with a poor prognosis8-9.

Visit https://www.hcp.novartis.com/virtual-congress/sabcs-2021/ for the latest information from Novartis, including our commitment to the Oncology community, and access to our SABCS Virtual Scientific Program data presentations (for registered participants).

About Piqray(r) (alpelisib)

Piqray is a kinase inhibitor developed for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after endocrine-based regimen7. Piqray is approved in 64 countries, including the US and European member states12.

Novartis is continuing to reimagine cancer with additional trials of Piqray. EPIK-B5 will be a large Phase III clinical trial of Piqray in combination with fulvestrant to complement the SOLAR-1 study13. Novartis is also studying the potential of Piqray in triple negative breast cancer (TNBC) in the EPIK-B3 Phase III clinical trial, in advanced HER2+ breast cancer in the EPIK-B2 Phase III clinical trial and in ovarian cancer in the EPIK-O Phase III clinical trial14-16.