FDA Approves Genentech’s Tecentriq Combination Therapy for First-Line Treatment of BRAF V600 Mutation-Positive Advanced Melanoma

Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved its blockbuster PD-L1 inhibitor Tecentriq (atezolizumab), in combination with the MEK inhibitor Cotellic (cobimetinib) and the BRAF inhibitor Zelboraf (vemurafenib), for the first-line treatment of patients with advanced melanoma harboring BRAF V600 mutations.

Melanoma is more aggressive and lethal than other types of skin cancer. When diagnosed early, melanoma is generally a curable disease; however, the prognosis for most patients with advanced-stage melanoma is poor. Approximately half of patients with advanced melanoma harbor the BRAF V600 mutation.

Tecentriq is a monoclonal antibody designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, thereby blocking its interaction with the PD-1 and B7.1 receptors. By inhibiting PD-L1-mediated signaling pathways, Tecentriq enhances T cell-mediated anti-tumor immune responses.

This approval is based on the results of the Phase 3 clinical trial IMspire150, in which Tecentriq plus Cotellic and Zelboraf prolonged progression-free survival (PFS) compared with placebo plus Cotellic and Zelboraf. The PFS was 15.1 months for the Tecentriq combination versus 10.6 months for the control group (HR=0.78, p=0.025).

“Patients with advanced melanoma harboring BRAF V600 mutations who receive combination therapy with cancer immunotherapy and targeted therapy can survive for more than 15 months without disease progression,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “Today’s FDA approval of the Tecentriq combination represents an important advance for many patients with advanced melanoma.”

References:

[1] FDA Approves Genentech’s Tecentriq plus Cotellic and Zelboraf for People With Advanced Melanoma. Retrieved July 30, 2020, from https://www.businesswire.com/news/home/20200730006043/en/FDA-Approves-Genentech%E2%80%99s-Tecentriq-Cotellic-Zelboraf-People

Original Title: Flash | Genentech’s Tecentriq Combination Therapy Approved for Expanded Indication in First-Line Treatment of Melanoma Patients

▽Follow [WuXi AppTecDe】WeChat Official Account