A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
Timeline
- Start
- 2020-01-29
- Primary completion
- 2023-09-29
- Completion
- 2027-11-15
Outcome
Met primary endpoint
registry analysis (superiority test); Inavo+Palbo+Fulv vs Pbo+Palbo+Fulv; p <0.0001; Hazard Ratio (HR) 0.43 (95% CI 0.32 to 0.59); Log Rank NCT04191499 ↗
release “Phase III (INAVO120) results show that inavolisib in combination with palbociclib and fulvestrant significantly improved progression-free survival in the first-line setting” roche.com ↗
release “The study met its primary endpoint of progression-free survival (PFS)” gene.com ↗
release “Approval is based on Phase III INAVO120 results, showing the ItovebiTM (inavolisib)-based regimen more than doubled progression-free survival” gene.com ↗
Publications
- Jhaveri KL, Im SA, Saura C, Loibl S, Kalinsky K, Schmid P, Loi S, Thanopoulou E, Shankar N, Jin Y, Stout TJ, Clark TD, Song C, Juric D, Turner NC. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Jul 10;393(2):151-161. doi: 10.1056/NEJMoa2501796. Epub 2025 May 31.
- Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inavolisib | Small molecule | 9 mg | Oral |
| Background | Fulvestrant | Small molecule | — | Intramuscular |
| Background | Palbociclib | Small molecule | — | Oral |