Head-to-head evidence

Alpelisib (BYL719) vs Inavolisib

Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.

HR+/HER2- Metastatic Breast Cancer

Shared mechanism: PI3K-alpha · full HR+/HER2- Metastatic Breast Cancer pipeline

Alpelisib (BYL719)

Marketed by Novartis

Approved in HR+/HER2- Metastatic Breast Cancersmall molecule (PI3K-alpha inhibitor)
Reliable signal

NCT02437318 · Phase 3 · completed

This was a randomized, triple-blind, placebo-controlled trial with 572 participants. The primary clinical endpoint, investigator-assessed progression-free survival in the PIK3CA-mutant cohort, was met: median progression-free survival was 11.0 versus 5.7 months, with a hazard ratio of 0.65 and one-sided p=0.00065.

Next expected readout: December 2026 · NCT05563220 (registry estimate)

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Inavolisib

Marketed by Roche

Approved in HR+/HER2- Metastatic Breast Cancersmall molecule
not yet graded

No graded featured trial for this indication yet; the grade above reflects that absence, not a judgment.

Next expected readout: November 2026 · NCT05646862 (registry estimate)

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The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: Alpelisib (BYL719)'s landscape · Inavolisib's landscape