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Survival Win With Inavolisib-Based Triplet in PIK3CA-Mutated Breast Cancer

The phase 3 INAVO120 study showed that adding inavolisib to palbociclib and fulvestrant significantly improved overall survival in PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer patients.
This result expanded on previously observed improvements in progression-free survival and stems from a randomized trial that enrolled a total of 325 patients with endocrine-resistant disease over the period from early 2020 through late 2023.
The median overall survival reached 34 months with inavolisib versus 27 months in the placebo group, and chemotherapy initiation was delayed from 12.6 to 35.6 months with the triplet regimen.
Dr. Nicholas C. Turner highlighted that this study marks a breakthrough by demonstrating improved overall survival using a drug targeting the PI3K pathway, alongside nearly a two-year extension in delaying the initiation of chemotherapy, underscoring its clinical significance.
These results, presented ahead of the 2025 ASCO Annual Meeting, support genomic testing for PIK3CA mutations and suggest that inavolisib could change standard care for this breast cancer subset despite manageable side effects.

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Pharmaphorum

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ASCO 25: Roche places Itovebi marker in breast cancer

Roche's Itovebi has become the first PI3K inhibitor to extend survival in HR-positive, HER2-negative breast cancer with a PIK3CA mutation

1 day ago

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MedPage Today

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Survival Win With Inavolisib-Based Triplet in PIK3CA-Mutated Breast Cancer

(MedPage Today) -- CHICAGO -- Adding the PI3K-pathway inhibitor inavolisib (Itovebi) to palbociclib (Ibrance) and fulvestrant significantly improved survival in advanced breast cancer patients with PIK3CA-mutated, endocrine-resistant disease...

2 days ago·New York, United States

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pharmaceutical-technology.com

ASCO25: Roche’s Itovebi combo reduces risk of death in breast cancer by 33% - Pharmaceutical Technology

The new OS results came from the Phase III INAVO120 study evaluating an Itovebi triple combination therapy.

23 hours ago

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oncnursingnews.com

Addition of Inavolisib Improves OS in PIK3CA-Mutant, HR+/HER2– Breast Cancer

The phase 3 INAVO120 trial showed that overall survival significantly improved with the addition of inavolisib to palbociclib and fulvestrant in PIK3CA-mutant, hormone receptor–positive, HER2-negative, endocrine-resistant advanced breast cancer.

1 day ago

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stocktitan.net

Breakthrough: Roche's New Breast Cancer Drug Doubles Survival Time, EU Approval Expected

New breast cancer treatment shows 57% reduction in disease progression for PIK3CA-mutated cases. First-line therapy doubles survival time to 15 months. See full data.

1 day ago

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Medscape

Benefits Persist With Inavolisib in PIK3CA-Mutated Breast Cancer

Mature overall survival results of the INAVO120 trial were presented in a press conference for the American Society of Clinical Oncology 2025 annual meeting. Medscape Medical News

2 days ago·United States

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