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ACPE Required Forms: PACULit Literature Updates September 2025: Oncology3 Topics
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Lesson 8,
Topic 1
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Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer
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Daily Literature Update
Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer
Arabshomali Arman, Goswami Swarnali, Masurkar Prajakta P, et al. Inavolisib for HR-Positive, HER2-Negative Advanced Breast Cancer: Clinical Trials and Patient Access Implication. Am J Clin Oncol. 2025 Jul 11. DOI: 10.1097/COC.0000000000001209.
Introduction
Breast cancer, particularly HR+/HER2- subtypes with PIK3CA mutations, poses a treatment challenge due to endocrine therapy resistance.
Study Type: Phase 3 randomized controlled trial
Population: PIK3CA-mutated HR+/HER2- advanced breast cancer patients
Intervention: Inavolisib plus palbociclib and fulvestrant
Primary Outcome: Overall survival
Key Findings
- Significant overall survival benefit adding inavolisib to standard therapy
- Safety profile consistent with PI3Kα inhibitor class effects, including hyperglycemia
- Comparable treatment discontinuation rates to prior PI3Kα inhibitor trials
Context & Related Research
- Jhaveri KL et al., 2025: INAVO120 phase 3 trial showing OS benefit with inavolisib (PMID:40454641), confirming PI3Kα inhibition efficacy.
- André F et al., 2019: SOLAR-1 trial demonstrated significant PFS improvement with alpelisib (PMID:31091374), leading to FDA approval.
- Narayan P et al., 2021: FDA approval summary emphasizing regulatory impact of alpelisib data (PMID:33168657).
- Ziegengeist JL et al., 2024: Pharmacovigilance study describing risks of hyperglycemia and ketoacidosis (PMID:38245400).
- Bello Roufai D et al., 2023: Real-world evidence noted efficacy and adverse event-driven discontinuation with alpelisib (PMID:36611120).
- The Oncologist, 2021: Conference abstract indicating potential long-term control in subgroups (PMID:34173298).
Clinical Implications
- Inavolisib offers an overall survival advantage for PIK3CA-mutated advanced breast cancer patients.
- PIK3CA mutation testing is essential to guide targeted therapy selection.
- Careful monitoring for hyperglycemia and other toxicities is critical for safe use.
Strengths & Limitations
| Strengths | Limitations |
|---|---|
| Large, phase 3 randomized controlled trial | No direct head-to-head comparison to alpelisib |
| Molecularly defined patient population | Long-term OS and QoL data still pending |
| Robust safety monitoring for class-specific toxicities | Potential underreporting of rare AEs in trial setting |
Future Directions
Direct comparative studies of inavolisib vs alpelisib, optimal sequencing strategies, and standardized management protocols for hyperglycemia are needed to further advance care.
Conclusion
Inavolisib combined with palbociclib and fulvestrant provides a meaningful overall survival benefit in PIK3CA-mutated advanced breast cancer with manageable class-specific toxicities.
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