FDA Approves Roche's Tecentriq in Combination with Chemotherapy as First-Line Treatment for Metastatic Non-Squamous NSCLC

Genentech, a member of the Roche Group, announced today that the U.S. FDA has approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel] and carboplatin) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) who do not have EGFR or ALK mutations.

This approval is based on the results of the Phase 3 clinical study IMpower130, which demonstrated that Tecentriq in combination with chemotherapy significantly prolonged patient survival compared with chemotherapy alone (median overall survival: 18.6 months vs. 13.9 months in the control group; hazard ratio [HR]=0.80; 95% confidence interval [CI]: 0.64–0.99; p=0.0384 in the wild-type population under intention-to-treat analysis). The Tecentriq-based combination therapy also significantly reduced the risk of disease progression or death (median progression-free survival [PFS]: 7.2 vs. 6.5 months; HR=0.75; 95% CI: 0.63–0.91; p=0.0024).

The safety profile of Tecentriq in combination with chemotherapy appears consistent with the known safety profiles of the individual agents, and no new safety signals have been identified.

“We are pleased to offer this Tecentriq-based combination therapy as a new treatment option that provides clinically meaningful survival benefits for patients with non-squamous non-small cell lung cancer,” said Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech. “Today’s approval provides another opportunity to extend the lives of patients with this disease.”

In lung cancer, Tecentriq has been approved in combination with Avastin (bevacizumab), paclitaxel, and carboplatin as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations. Additionally, Tecentriq is FDA-approved for the treatment of adult patients with metastatic NSCLC who have experienced disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should receive FDA-approved therapy prior to receiving Tecentriq. Tecentriq in combination with carboplatin and etoposide is also approved for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).

Genentech has undertaken an extensive development program for Tecentriq, including nine ongoing Phase 3 clinical trials in various types of lung cancer, as well as multiple ongoing and planned Phase 3 clinical trials in urogenital, skin, breast, gastrointestinal, gynecologic, and head and neck cancers. These studies evaluate the efficacy of Tecentriq as a monotherapy or in combination with other agents.

References:

[1] FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for the Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer. Retrieved 2019-12-04, from https://www.businesswire.com/news/home/20191203006105/en

Headline: Flash | FDA Approves Roche’s Tecentriq in Combination with Chemotherapy as First-Line Treatment for Metastatic Non-Squamous NSCLC

▽Follow [WuXi AppTecDe】WeChat Official Account