FDA Approves Frontline Tecentriq/Chemotherapy for Metastatic Non-Squamous NSCLC
The Food and Drug Administration approved Tecentriq in combination with chemotherapy for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer without EGFR or ALK mutations.
BY Kristie L. Kahl
PUBLISHED December 04, 2019
The Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations, according to Genentech, the agent’s manufacturer.
“We are pleased to offer this Tecentriq-based combination as a new treatment option that can provide a clinically meaningful survival benefit for people with non-squamous non-small cell lung cancer,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genetech, said in a press release. “(This) approval offers another opportunity to help prolong the lives of people with this type of the disease.”
The agency’s approval was based on results from the multicenter, open-label, randomized phase 3 IMpower130 study, designed to evaluate the efficacy and safety of Tecentriq in combination with Abraxane (nab-paclitaxel) and carboplatin compared with chemotherapy alone for chemotherapy-naïve patients with stage 4 non-squamous NSCLC.
Median overall survival was 18.6 months in the Tecentriq arm, compared with 13.9 months in the chemotherapy arm, while progression-free survival (the time from treatment to disease progression or worsening) was 7.2 months versus 6.5 months, respectively.
The safety profile of the Tecentriq arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Grade 3/4 side effects occurred in 73.2% of patients in the Tecentriq arm, compared with 60.3% of those receiving chemotherapy alone.
Check back later to learn more about how this approval will affect patients with metastatic NSCLC.