First-line atezolizumab plus nab-paclitaxel improved PFS compared with placebo among patients with metastatic or unresectable locally advanced triple-negative breast cancer, according to interim results from the IMpassion130 trial released by the manufacturer.
Researchers observed prolonged PFS in both the intention-to-treat population and the PD-L1-positive population.
Atezolizumab (Tecentriq, Roche) — a PD-L1 monoclonal antibody — is approved for the treatment of patients with previously treated metastatic non-small cell lung cancer and for certain types of untreated or previously treated metastatic urothelial carcinoma.
In the phase 3 double-blind, multicenter IMpassion130 study, researchers randomly assigned 902 patients with metastatic or unresectable locally advanced triple-negative breast cancer to atezolizumab plus nab-paclitaxel (Abraxane, Celgene) or placebo plus chemotherapy.
PFS and OS in both the intention-to-treat population and the PD-L1-positive population served as co-primary endpoints. Secondary endpoints included objective response rate, duration of response and time to deterioration.
Today, Roche announced investigators observed prolonged PFS in the intention-to-treat population and the PD-L1-positive population. The OS analysis is ongoing; however, researchers observed encouraging survival results among patients who are PD-L1 positive.
“IMpassion130 is the first positive phase 3 immunotherapy study in triple-negative breast cancer, an aggressive disease with limited treatment options,” Sandra Horning, MD, chief medical officer and head of global product development at Roche, said in a company-issued press release. “Highly encouraged by these results, we plan to submit to health authorities globally with the aim of bringing this combination to people with triple-negative breast cancer as soon as possible.”
Safety of the combination appeared consistent with the known profiles of the individual medicines. Researchers observed no new safety signals.
Results will be presented at an upcoming medical meeting