Roche's Tecentriq gains European approval for triple-negative breast cancer

Roche announced Thursday that the European Commission approved Tecentriq (atezolizumab) plus chemotherapy for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression and who have not received prior chemotherapy for metastatic disease. The company noted that the Tecentriq combination "marks the first cancer immunotherapy regimen" to be available in Europe for triple-negative breast cancer.

The approval is based on results from the Phase III IMpassion130 study, which showed that Tecentriq in combination with Celgene's Abraxane (nab-paclitaxel) reduced the risk of disease worsening or death by 38% compared to Abraxane alone. Median progression-free survival in people who tested positive for PD-L1 expression on tumour-infiltrating immune cells was 7.5 months and 5 months in the two groups, respectively. Meanwhile, Tecentriq and Abraxane also demonstrated a clinically meaningful overall survival improvement of seven months versus placebo and Abraxane.

Roche noted that PD-L1 expression status in the IMpassion130 study was assessed using the VENTANA PD-L1 (SP142) assay, which is now CE marked and commercially available in the EU.

Tecentriq, which inhibits PD-L1, is also approved in a number of countries, including the US and Europe, either alone or in combination with targeted therapies and chemotherapies in various forms of non-small-cell and small-cell lung cancer, as well as certain types of metastatic urothelial cancer. The product is on track to generate sales of more than $1.5 billion in 2019, having posted revenue of CHF 782 million ($796 million) in the first half of the year.

Earlier this month, Roche reported that the combination of Tecentriq and platinum-based chemotherapy showed a significant reduction in the risk of disease worsening or death in patients with previously untreated locally advanced or metastatic urothelial carcinoma compared with chemotherapy alone. For related analysis, see KOL Views Results: Roche's IMvigor130 win exciting, but doubts remain about if, how I/O fits in 1L bladder cancer, says leading urologist.

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