Roche shares positive late-stage results for inavolisib combination in advanced breast cancer

07 Dec 2023
www.pmlive.com
Phase 3Clinical ResultDrug Approval
Roche has shared positive results from a late-stage study of its investigational therapy, inavolisib, as part of a combination treatment for advanced breast cancer.
Rochehase 3 INAVO120 trial has been evaluating the targeted drug alongside Pfizer’s CDK4/6inavolisib Ibrance (palbociclib) and fulvestrant asadvanced breast cancere treatment option for patients with PIK3CA-mutated, hormone receptor (HR)-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer.
The study met its primary endpoint, demonstrating a statistically significaPfizer clCDK4/6 inhibitor Ibranceovpalbociclibogressfulvestrantrvival compared to palbociclib and fulvestrant alone.PIK3CAHER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer
A "clear positive trend” towards improved survival was also observed for the inavolisib combination, Roche said, although overall survival data was immature palbociclib of tfulvestrant and will continue to be analysed.
Breast cancer is the most common cancer worldwide, with more than 290,000 peoinavolisib US expected tRochediagnosed with the disease in 2023.
Breast cancerreast cancer is the cancerommon subtype and PIK3CA mutations, which have been linked to tumour growth, disease progression and treatment resistance, are found in approximately 40% of HR-positive breast cancers.
HRcording to Roche, inavolisib could “provide well-toleraPIK3CAurable disease control and potentiallytumourved outcomes” for this subset of patients.HRpositive breast cancers
Levi GarrawayRocheheinavolisibedical officer and head of global product development, said the results from INAVO120 “could represent a transformative medical advance for people with PIK3CA-mutated HR-positive breast cancer”.
"We look forwarRocheexpanding our portfolio of breast cancer medicines into the HR-positive space and bringing this potentially best-in-class new treatment option to patients as quicPIK3CA mutated HR-positive breast cancer
The readout comes less than a month after an inbreast cancer of Roche's PD-L1 inHRbitor Tecentriq (atezolizumab) was recommended by the European Medicines Agency’s human medicines committee for multiple cancer types, including certain types of breast, lung, liver and bladder cancer.
The subcutaneous formulation of Tecentriq, which can cut treatmeRocheme PD-L1proximatelyTecentriq aatezolizumabapproved by the MedicinesEuropean Medicines AgencyRegulatory Agency.cancer
The company’s Genentech unit andTecentriqt Medicines also received full approval from the US Food and Drug Administration earliMedicines and Healthcare products Regulatory Agencyapy Gavreto (pralsetinib) in a subset of non-small cell lung cancer patients.
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