ASCO: BYLieve study results

Abstract No : 1006

Abstract Type : Oral Abstract Session

Indication : Her2-Negative Breast Cancer

Intervention : Alpelisib (ALP) + fulvestrant (FUL)

Company : Novartis Pharmaceuticals

Technology : Small Molecule


127 pts whose immediate prior tx was CDKi + AI were enrolled, of whom 121 had centrally confirmed PIK3CA mut; median follow-up was 11.7 mo. Primary endpoint was met: proportion of pts without disease progression at 6 mo was 50.4% (95% CI, 41.2-59.6). Most frequent all-grade AEs were diarrhea (60%), hyperglycemia (58%), nausea (46%), fatigue (29%), decreased appetite (28%), and rash (28%). Most frequent grade ≥3 AEs included hyperglycemia (28%), rash (9%), and rash maculopapular (9%). Incidence of AEs leading to discontinuation was low; most frequent AEs leading to discontinuation were rash (5 pts, 3.9%), colitis, hyperglycemia, urticaria, and vomiting (2 pts, 1.6% each).


With follow-up still ongoing, BYLieve shows in a large number of pts that ALP + FUL demonstrates clinically meaningful efficacy and manageable toxicity post CDKi tx. Building on findings from SOLAR-1, BYLieve further supports use of ALP + FUL for HR+, HER2–PIK3CA-mut ABC.


BYLieve demonstarted clinically meaningful efficacy of Alpelisib (ALP) + fulvestrant (FUL) in PIK3CA-mutated HR+ HER2-VE ABC post progression on CDKi + AI with manageable side effects. According to Delveinsight's analysis it will be a potential option for treatment refractory patients.

Refer to Her2-Negative Breast Cancer Market report for detailed Insights.