Roche’s inavolisib hits main goal of breast cancer study

05 Dec 2023
firstwordpharma.com
Clinical ResultPhase 3
Roche announced Tuesday that its experimental drug inavolisib met the primary endpoint of a Phase III study in patients with advanced hormone receptor (HR)-positive, HER2-negative breast cancer with a PIK3CA mutation. The company noted that it will submit findings from the INAVO120 trial to regulators.
"These pivotal study results…could represent a transformative medical advance for people with PIK3CA-mutated HR-positive breast cancer," suggested Levi Garraway, Roche’s chief medical officer.
The trial enrolled 325 patients with PIK3CA-mutated, 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. Subjects were randomised to receive inavolisib or placebo, both in combination with Pfizer’s Ibrance (Palbociclib) and fulvestrant.
"Clear positive" survival trend
Roche noted that for the primary endpoint, inavolisib demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus placebo. The company indicated that data for the secondary goal of overall survival are still immature, although “a clear positive trend has been observed.” Other secondary endpoints include objective response rate and clinical benefit rate.
According to Roche, the inavolisib regimen was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments. Further results will be presented at an upcoming medical meeting.
Inavolisib, an oral therapy that inhibits PI3Kα, is also being investigated in the late-stage INAVO121 and INAVO122 studies, involving various combinations with Phesgo (pertuzumab/trastuzumab) and Novartis’ Piqray (alpelisib).
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