The Absolute Effect / Evidence index

Advanced / Metastatic · Phase III double-blind randomized; N=325; PIK3CA-mutated HR+/HER2− advanced breast cancer relapsing during/within 12 months of adjuvant endocrine therapy. Inavolisib+palbociclib+fulvestrant vs placebo+palbociclib+fulvestrant. Final OS analysis. · Median OS 34.0 vs 27.0 months

INAVO120

Clinical question: Does adding inavolisib to palbociclib and fulvestrant improve OS in PIK3CA-mutated HR-positive/HER2-negative advanced breast cancer with early relapse after adjuvant endocrine therapy?

Median OS 34.0 vs 27.0 months; HR 0.67 (95% CI 0.48–0.94; P=0.02). ORR 62.7% vs 28.0%; ORR-based NNT 3. · Registry:

Design, population and treatment

Phase III double-blind randomized; N=325; PIK3CA-mutated HR+/HER2− advanced breast cancer relapsing during/within 12 months of adjuvant endocrine therapy. Inavolisib+palbociclib+fulvestrant vs placebo+palbociclib+fulvestrant. Final OS analysis.

Key efficacy outcome

62.7 · intervention
28
62.7 · comparator
NNT 3 for one additional objective response (ORR difference 34.7 points); not an OS NNT.

AEs led to inavolisib discontinuation 6.8% vs placebo discontinuation 0.6%; hyperglycaemia, stomatitis, GI and ocular toxicities more frequent.

Safety and absolute effect

Objective response rate (%)

https://www.nejm.org/doi/full/10.1056/NEJMoa2501796

Interpretation and limitations

Current-practice context · 14 November 2026: Primary publication/abstract and trial identifier checked. Guideline-level current-practice mapping was not established in this publication-led batch; no NCCN citation provenance is claimed. Where detailed QoL, follow-up or toxicity data were not present in the retrieved abstract, they are not inferred.

Primary source

Primary publication · DOI: 10.1056/NEJMoa2501796