Roche Holding AG Tecentriq failed in a late-stage clinical trial to extend the lives of patients with an aggressive type of breast cancer without their disease worsening.
The Swiss drugmaker was studying Tecentriq, or atezolizumab, in combination with chemotherpy paclitaxel against placebo and paclitaxel as an initial treatment for patients with triple-negative breast cancer who are PD-L1 positive. Patients in the trial also had disease that had spread to other parts of the body.
Triple-negative breast cancer can be more difficult to treat as the disease is not sensitive to hormone therapy or medicines that target the HER2 gene mutation. PD-L1 is a protein found on cancer cells, and patients with high levels respond well to certain treatments.
Results from the phase 3 trial, dubbed IMpassion131, showed the Tecentriq combination failed to meet the primary objective of the study, according to Roche's Aug. 6 news release.
The drug combination showed a negative trend in extending the duration patients lived with the disease — a metric known as overall survival — but data was not yet ready for analysis, Roche said. Overall survival data will be reviewed through the final analysis of the trial.
In an earlier study, IMpassion130, a combination of Tecentriq and the brand name paclitaxel product Abraxane significantly extended the lives of patients while keeping the disease from worsening, which is known as progression-free survival. Bristol-Myers Squibb Co. chemotherapy drug Abraxane was acquired through the recent acquisition of Celgene Corp. and is an injectable form of the chemotherapy paclitaxel.
"Today's results underscore the need to better understand the cancer and immune system interactions, including the chemotherapy backbone and associated regimens," said Levi Garraway, Roche's chief medical officer and head of global product development. "We remain committed to finding optimal treatments for all people living with this aggressive disease."
Full results will be issued at an upcoming medical meeting and will be used to inform future studies of Tecentriq and the chemotherapy paclitaxel in triple-negative breast cancer.
Roche is evaluating the drug, already approved in several countries to treat different types of cancer, in clinical trials covering patients with skin, breast, gynecological, and head and neck cancers.
The U.S. Food and Drug Administration recently approved Tecentriq in combination with Cotellic and Zelboraf for treating BRAF V600 mutation-positive advanced melanoma, a type of advanced skin cancer.
