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Overall survival (os) results from SOLAR-1, a phase III study of alpelisib (ALP) + fulvestrant (FUL) for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC)
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ESMO: SOLAR1 Results
Abstract No : Abstract: #LBA18
Indication : Breast cancer
Intervention : Alpelisib
Company : Novartis
Technology : PI3K Inhibitor
Results:
With mOS follow-up of 30.8 mo, mOS was 39.3 mo (95% CI 34.1-44.9) with ALP + FUL and 31.4 mo (95% CI 26.8-41.3) with PBO + FUL (HR 0.86; 95% CI 0.64-1.15; P=0.15); OS did not cross the prespecified boundary. Median time to chemotherapy (TTC) was 23.3 mo (95% CI 15.2-28.4) with ALP + FUL and 14.8 mo (95% CI 10.5-22.6) with PBO + FUL (HR 0.72; 95% CI 0.54-0.95). In pts with lung and/or liver metastases, mOS was 37.2 mo (95% CI 28.7-43.6) with ALP + FUL and 22.8 mo (95% 19.0-26.8) with PBO + FUL (HR 0.68; 95% CI 0.46-1.00). No new safety signals were observed with longer follow-up.
Conclusion:
Though not statistically significant, OS was prolonged by a clinically relevant ≈8 mo with ALP when added to FUL in HR+, HER2−, PIK3CA-mut ABC. mTTC was also prolonged with ALP + FUL vs PBO + FUL. Coupled with the statistically and clinically significant PFS, these data further support ALP + FUL in this poorer prognostic population of pts with PIK3CA-mut ABC
Executive Summary
Novartis presented the Overall survival (OS) results from SOLAR-1, a phase III study which evaluated alpelisib (ALP) + fulvestrant (FUL) for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC). . In the phase III SOLAR-1 trial patients with PIK3CA-mutant (mut) cohort, 86% had resistance to ET and half of patients received treatment as 2nd line therapy. The study showed that, in the patients with PIK3CA-mutant (mut) cohort, mOS was 39.3 months in the alpelisib Arm vs 31.4 n the placebo arm. This means that the mOS was significantly prolonged by 7.9 months for the patients in Alpelisib arm. Median time to chemotherapy (TTC) was also prolonged with ALP + FUL vs PBO + FUL. Coupled with the statistically and clinically significant PFS, these data further support ALP + FUL in this poorer prognostic population of pts with PIK3CA-mut ABC.