Adding Tecentriq (atezolizumab) to the chemotherapy Abraxane (nab-paclitaxel) significantly delays the time to worsening disease or death in patients with metastatic triple negative breast cancer (TNBC), a Phase 3 trial shows.
The therapy combination delayed disease progression in both the overall population and in patients with PD-L1 positive tumors, a biomarker that predicts response to Tecentriq. The combo met two of the trial’s primary goals.
The efficacy, safety, and pharmacokinetics of Tecentriq and Abraxane were compared to that of a placebo and Abraxane. Pharmacokinetics is the study of a therapy’s absorption, distribution, metabolism, and excretion.
A total of 902 patients were enrolled in the trial. Participants were randomly assigned Tecentriq or a placebo — given every two weeks — along with weekly chemotherapy at a schedule of three weeks on, one week off. Treatment was administered until patients experienced signs of disease progression or toxicity.
In addition to extending the time a patient lived without signs of disease progression, Roche notes that patients whose cancer expressed the PD-L1 protein also showed encouraging survival results.
Safety results in patients who received Tecentriq plus Abraxane appeared to match the known safety profiles of the individual therapies. No new safety concerns were identified.
Other planned analyses include objective response rate — the proportion of patients with a predefined reduction in tumor size over a minimum period of time — and duration of response.
Roche plans to present the results of the IMpassion130 trial at an upcoming medical meeting. The study is expected to be completed by April 2020.
“IMpassion130 is the first positive Phase 3 immunotherapy study in triple-negative breast cancer, an aggressive disease with limited treatment options,” Sandra Horning, chief medical officer and head of global product development at Roche, said in a press release.
The results will now be submitted to the U.S. Food and Drug Administration, the European Medicines Agency (EMA), and other health authorities “with the aim of bringing this combination to people with triple-negative breast cancer as soon as possible,” Horning said.
TNBC represents about 15 percent of all breast cancer cases and refers to the lack of production of human epidermal growth factor receptor 2, estrogen receptors, and progesterone receptors.
Tecentriq is approved in the U.S., E.U., and over 70 countries for patients with previously treated metastatic non-small cell lung cancer, and for certain types of untreated or previously treated metastatic urothelial carcinoma.
In addition to IMpassion130, Roche has six more ongoing Phase 3 trials investigating Tecentriq in TNBC. A Phase 1 (NCT01375842) trial showed that women with metastatic TNBC who respond to Tecentriq live longer than those who do not.
The company is also testing the medication in Phase 3 studies across colorectal, lung, kidney, skin, ovarian, bladder, prostate, blood, liver, and head and neck cancers. These studies assess Tecentriq both alone and in combination with other medications, including Abraxane.