Pfizer (NYSE:PFE) on Tuesday announced that a Phase 3 trial designed to test its FDA-approved antitumor agent Tukysa as a first-line maintenance therapy in breast cancer reached its main goal with a favorable safety profile.
Citing topline data from its Phase 3 HER2CLIMB-05 trial, the New York-based pharma giant said that the tyrosine kinase inhibitor as a combination therapy met the study’s primary endpoint, leading to a statistically significant and clinically meaningful progression-free survival.
Currently, Tukysa is indicated in the U.S. as a late-line combination therapy for adults with HER2-positive advanced unresectable or metastatic breast cancer.
HER2CLIMB-05 was a placebo-controlled trial designed to test Tukysa with first-line standard-of-care maintenance therapy, trastuzumab and pertuzumab, in those with HER2+ metastatic breast cancer.
Based on tolerability data, the company noted that Tukysa with trastuzumab and pertuzumab was tolerable and demonstrated a safety profile consistent with the established safety profiles of each drug. Pfizer (NYSE:PFE) expects to share full results from the trial at a future medical event and with regulatory officials.