The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency , has recommended the approval of Tecentriq (atezolizumab) in combination with the chemotherapy Abraxane (nab-paclitaxel) as a first-line treatment for some advanced triple-negative breast cancers (TNBC).
Specifically, the recommendation is for adult patients with locally advanced or metastatic cancer that cannot be removed by surgery, who have not received prior chemotherapy for their metastatic disease, and whose tumors test positive for the PD-L1 factor.
It is based on findings from the IMpassion130 Phase 3 trial (NCT02425891), where the combination reduced the risk of disease progression or death by 38% and extended survival by seven months in the PD-L1-positive population, compared with Abraxane only.
“This CHMP recommendation marks a breakthrough in the treatment of triple-negative breast cancer, an aggressive type of breast cancer with high unmet medical need,” Sandra Horning, Roche’s chief medical officer and head of global product development, said in a press release.
“With today’s announcement, we hope that people living with PD-L1-positive metastatic triple-negative breast cancer in Europe will soon have a new treatment option with the Tecentriq combination,” Horning added.
Tecentriq is an immune checkpoint inhibitor (developed by Genentech, a Roche subsidiary) that prevents cancer cells from evading immune surveillance. It specifically interacts with the PD-L1 protein on cancer cells, preventing it from binding to the PD-1 receptor on immune cells.
IMpassion130, a multi-center, randomized, double-blind trial, included 902 TNBC patients who had not received prior treatment for their locally advanced or metastatic breast cancer.
The trial was designed to examine if adding Tecentriq to Abraxane could improved the survival outcomes — overall survival and survival without disease worsening — in the total population and in a subset of patients with PD-L1-positive tumors. Secondary measures included objective response rates and duration of responses.
In the overall population, the combination reduced the risk of disease worsening or death by 20%, leading to a median progression-free survival of 7.2 months, compared with 5.5 months for chemotherapy alone. It also extended the median overall survival from 18.7 months to 21 months, but without reaching statistical significance.
In the PD-L1-positive population, on the other hand, both survival outcomes were significantly improved when Tecentriq was added to Abraxane. These patients lived without disease worsening for 7.5 months, compared with five months for chemotherapy, meaning that the risk of disease progression or death had been cut by 38%.
Survival was also extended from 18 months to 25 months, but because statistical significance was not reached in the overall population, these results were not formally tested.
The combo regimen’s safety profile appears to be consistent with previous data for the individual therapies. No new safety concerns have been reported.
Serious side effects were seen in 23% of participants given the combination, compared with 18% of patients receiving Abraxane alone. Severe or life-threatening side effects were seen in 49% of the combo therapy group and in 42% of the patients taking Abraxane.