Roche announced that its Phase III IMpassion130 clinical trial met its co-primary endpoint of progression-free survival (PFS) in triple-negative breast cancer (TNBC).
Roche announced that its Phase III IMpassion130 clinical trial met its co-primary endpoint of progression-free survival (PFS) in triple-negative breast cancer (TNBC).
Triple-negative breast cancer represents about 15 percent of all breast cancers and is more common in women under the age of 50 compared to other types of breast cancer. The triple-negative refers to lack of expression and/or amplification of the targetable receptors for estrogen, progesterone and HER2 amplification.
Triple-negative breast cancer patients typically have rapid progression and shorter overall survival compared to other breast cancer subtypes. Patients with this type of breast cancer don’t respond well to hormone therapies or drugs like Roche’s Herceptin.
Tecentriq (atezolizumab) and chemotherapy (Celgene’s Abraxane) as a first-line treatment in the trial showed a significant reduction in the risk of the disease getting worse or death (PFS) in the intention-to-treat and PD-L1 positive population with metastatic or unresectable locally advanced triple-negative breast cancer. Overall survival (OS) was encouraging in the PD-L1 positive population in interim analysis. The company plans to continue until its next planned analysis.
The drug’s safety in the nab-paclitaxel arm was consistent with the known safety profiles of both drugs alone and no new ones were observed.
“IMpassion130 is the first positive Phase III immunotherapy study in triple negative breast cancer, an aggressive disease with limited treatment options,” said Sandra Horning, Roche’s chief medical officer and Head of Global Product Development, in a statement. “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.”
The IMpassion130 trial evaluated Tecentriq and nab-paclitaxel compared to placebo in combination with nab-paclitaxel in patients with locally advanced or metastatic TNBC who had not received previous systemic therapy for metastatic breast cancer (mBC). It looked at 902 patients, randomized in a one-to-one ratio. The co-primary endpoints were progression-free survival per investigator assessment and overall survival. PFS and OS were also evaluated in all randomized participants and in patients who expressed the PD-L1 protein. Secondary endpoints included objective response rate, duration of response and time of deterioration in Global Health Status/Health-Related Quality of Life.
Tecentriq is a monoclonal antibody that binds with the PD-L1 protein. By inhibiting PD-L1, the drug enables T cells to activate, allowing the immune system freer rein to attack the cancer.
The drug has been approved in Europe, the U.S. and more than 70 other countries for individuals with previously treated metastatic non-small cell lung cancer (NSCLC) and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).
Because this patient population with TNBC has an aggressive disease, and the current treatment options are surgery and chemotherapy, the possibility of Tecentriq being approved for this indication is a positive one for patients and the company.
Roche hasn’t released detailed data, which it will present at an upcoming medical conference. But the company is likely preparing applications for this indication to the U.S. Food and Drug Administration (FDA)and the European Medicines Agency (EMA).
Roche’s Tecentriq is generally viewed as the third most popular PD-L1 inhibitor, behind Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda. If the data for Tecentriq in TNBC is good enough, it should be able to keep that position as AstraZeneca’s Imfinzi battles it for non-small cell lung cancer.
