The Food and Drug Administration’s warning comes weeks after Genentech, the manufacturer of Tecentriq, issued a press release noting that the IMpassion131 trial failed to meet its primary endpoint of improving progression-free survival in patients with triple-negative breast cancer.
The Food and Drug Administration (FDA) on Tuesday issued a warning to patients, health care providers and trial investigators that the IMpassion131 trial — which evaluated the efficacy and safety of the immunotherapy Tecentriq (atezolizumab) in combination with the chemotherapy paclitaxel in patients with PD-L1-positive metastatic triple-negative breast cancer (mTNBC) — failed to effectively treat the disease.
The warning from the FDA comes weeks after Genentech, the manufacturer of Tecentriq, issued a press release noting that the trial failed to meet its primary endpoint of improving progression-free survival.
The FDA reiterated, in an agency-issued press release, that the combination of Tecentriq and paclitaxel is not approved for use in breast cancer. But, Tecentriq is approved in combination with Abraxane (paclitaxel protein-bound) to treat adults with PD-L1-positive mTNBC.
Although the data is not yet available to the public, the agency noted that the combination of Tecentriq and paclitaxel failed to reduce the risk of cancer progression and death compared with placebo and paclitaxel in PD-L1-positive patients. Interim overall survival data also favored the placebo and paclitaxel combination.
The agency notes that it will continue to review the trial’s findings and communicate any new information regarding the trials results to the public. The FDA is also assessing the use of the Tecentriq and paclitaxel combination in other existing breast cancer trials and will recommend additional changes if needed.
Patients, according to the agency, should continue receiving the Tecentriq and paclitaxel combination for other approved uses as long as it is advised by their health care provider.
The continued approval of Tecentriq in combination with Abraxane, according to the FDA, could be contingent of continued proven benefits in other trials.
If patients have any concerns, the FDA recommends they speak with their doctor. Additionally, any adverse events or side effects related to treatment should be reported to the agency.