Roche’s Tecentriq scores CHMP recommendation in PD-L1+ metastatic triple-negative breast cancer
pharmafile | July 2, 2019 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Roche, breast cancer, pharma, tecentriq
Roche’s immunotherapy Tecentriq (atezolizumab) has been recommended by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in combination with Abraxane chemotherapy to be used in the initial treatment of PD-L1-positive, metastatic triple-negative breast cancer in adult patients who have not previously received chemotherapy, it has emerged.
While not binding, the positive ruling is expected to be a good predictor of a final regulatory decision for the therapy in Europe.
Phase 3 data submitted in support of the drug application indicated that the Tecentriq combo “significantly reduced the risk of disease worsening or death”, improving progression-free survival by 38% compared to chemotherapy alone in participants who tested positive for PD-L1 expression on tumour-infiltrating immune cells. The combo also improved overall survival compared to chemotherapy in the PD-L1+ population.
“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,” commented Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “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.”
Roche confirmed that the study will continue in order to gather more data; it is one of seven ongoing Phase 3 studies in which Tecentriq is being tested for triple-negative breast cancer.
Matt Fellows
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