When given alongside chemotherapy, Tecentriq (atezolizumab) increases the percentage of people with early triple-negative breast cancer (TNBC) who show no signs of cancer during tumor removal surgery, a Phase 3 trial shows.
These results were found regardless of the patient’s PD-L1 status, or the amount of the PD-L1 protein on the individual’s cancer cells.
The study, called IMpassion031 (NCT03197935), is the second Phase 3 trial carried out by Genentech showing the benefits of Tecentriq for people with TNBC. It is the first to demonstrate that these benefits also can be attained in patients at the early stages of the disease.
“Triple-negative breast cancer remains an aggressive disease with high rates of recurrence,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a press release.
“Our goal in treating TNBC at its earliest stages is to provide people with the best chance for a future cure,” Garraway saidd. “Adding Tecentriq to chemotherapy now has the potential to help women with TNBC at multiple different stages of the disease.”
Tecentriq, developed by Genentech, a Roche subsidiary, is an immune checkpoint inhibitor that has been approved to treat different types of cancer, including bladder and non-small cell lung cancer.
The medication works by binding PD-L1, a substance produced by cancer cells, and preventing it from interacting with its receptor, called PD-1, which can be found on the surface of immune cells. Through this mechanism, Tecentriq blocks the signaling cascade that allows cancer cells to evade being targeted and killed by immune cells.
Tecentriq has been approved in the U.S. and the E.U. as part of a combo treatment for people with advanced PD-L1-positive TNBC. It is given in combination with the chemotherapy agent Abraxane (nab-paclitaxel).
Both approvals were based on data from the IMpassion130 trial (NCT02425891), Genetech’s first Phase 3 trial for Tecentriq. That study showed that Tecentriq, in combination with Abraxane, reduced the risk of death or disease progression by 40% compared with Abraxane alone.
Now, Genentech announced new data from its second Phase 3 trial, which is assessing the safety and efficacy of Tecentriq in combination with chemotherapy — Abraxane, followed by doxorubicin and cyclophosphamide — as a neoadjuvant treatment for people with early TNBC who never received any form of therapy. Neoadjuvant treatment is usually a “first step” therapy, given patients to shrink a tumor before they receive their main treatment, which is usually surgery.
The trial also included a treatment control group, in which patients received a placebo in combination with chemotherapy, before undergoing tumor removal surgery.
The study’s main goal was to assess the percentage of patients attaining a pathological complete response, meaning those showing no signs of cancer by the time they underwent tumor removal surgery. This endpoint was assessed in the overall population of patients participating in the trial, as well as in those whose tumors expressed PD-L1.
New data now being announced by the company shows that IMpassion031 met its primary goal. Tecentriq in combination with chemotherapy was found to be superior to chemotherapy alone at increasing the percentage of patients who showed no evidence of remnant cancer tissue during surgery. This was true in all patients, including those whose tumors contained PD-L1.
The combination therapy had a safety profile that was consistent with the known safety profile of each medication when given separately. No new safety concerns were identified during the study.
Genentech is planning to present the full data from IMpassion031 at an upcoming medical meeting. It also will share the findings with worldwide regulatory health authorities, including the U.S. Food and Drug Administration and the European Medicines Agency.
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