BioPharma

Roche’s Tecentriq approved as first immunotherapy drug for breast cancer

The drug received accelerated approval for combination with Celgene's Abraxane based on Phase III data. According to a study, PD-L1-positive patients account for 26 percent of TNBC patients overall.

By Alaric DeArment on March 11, 2019

Roche’s headquarters in Basel, Switzerland

The Food and Drug Administration has approved the first ever immunotherapy regimen for breast cancer.

Swiss drugmaker Roche said Monday that the FDA had granted accelerated approval to the PD-L1 checkpoint inhibitor Tecentriq (atezolizumab), combined with Celgene’s Abraxane (nab-paclitaxel), for triple-negative breast cancer that cannot be removed with surgery and is locally advanced or metastatic. The FDA also approved a companion diagnostic, Roche’s Ventana PD-L1 Assay, for detecting the immune checkpoint in TNBC patients.

TNBC – defined as breast cancer that does not express estrogen receptor, progesterone receptor or HER2 genes – is an aggressive form of the disease that is diagnosed in approximately 300,000 women globally, representing 15 percent of all breast cancer cases. The disease is typically treated with a combination of surgery, radiation and chemotherapy, but because it does not express HER2, drugs that target it do not work, and nor do hormone therapies.

According to a 2016 study of 197 TNBC patients conducted at the Harvard Medical School, 26 percent of cases were found to express PD-L1. Monday’s approval is only for TNBC patients whose cancers express PD-L1.

The accelerated approval is based on data from the 902-patient Phase III IMpassion130 study, which showed that the combination produced a median progression-free survival – meaning the length of time patients remain alive without their disease worsening – of 7.4 months, compared with 4.8 months for Abraxane alone. Data for overall survival, meaning the amount of time patients remain alive, remained immature. The company said further data will be shared with the FDA and presented at an unnamed upcoming medical meeting.

“The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic, triple-negative breast cancer, a disease with high unmet medical need,” Roche Chief Medical Officer Sandra Horning said in a statement. “This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease.”

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Merck & Co.’s PD-1 inhibitor Keytruda (pembrolizumab) is also in three ongoing company-sponsored Phase III studies in TNBC, while other checkpoint inhibitors are the subject of clinical research in the disease as well, including Bristol-Myers Squibb Opdivo (nivolumab), according to ClinicalTrials.gov.

Tecentriq was already approved for non-small cell lung cancer and urothelial carcinoma, with the latter indication also under accelerated approval.

Photo: Roche