The Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab; Genentech) in combination with chemotherapy (Abraxane [paclitaxel protein-bound, nab-paclitaxel; Celgene] and carboplatin) for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
The approval was based on data from the phase 3, multicenter, open-label IMpower130 study that evaluated the safety and efficacy of atezolizumab in combination with chemotherapy (nab-paclitaxel + carboplatin) vs chemotherapy alone for up to approximately 35 months. Patients (N=724) with metastatic non-squamous NSCLC who had not received prior chemotherapy were randomized 2:1 to receive either atezolizumab in combination with chemotherapy vs chemotherapy alone. The co-primary end points were overall survival (OS) and progression-free survival (PFS).
Results demonstrated that patients treated with atezolizumab in combination with chemotherapy had a greater overall survival compared with chemotherapy alone (median OS: 18.6 months vs 13.9 months; hazard ratio [HR] 0.80, 95% CI: 0.64-0.99; P =.0384) in the intention-to-treat wild-type (ITT-WT) population. Additionally, atezolizumab-based combination reduced the risk of disease worsening or death vs chemotherapy alone (median PFS: 7.2 months vs 6.5 months; HR 0.75, 95% CI: 0.63–0.91; P =.0024) in the ITT-WT population.
With regard to safety, no new safety signals were noted in the trial and safety profiles were similar to those seen with the individual drugs. Atezolizumab-based combination chemotherapy reported a greater incidence of Grade 3-4 treatment-related adverse events vs chemotherapy alone (73.2% vs 60.3%, respectively).
“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,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “Today’s approval offers another opportunity to help prolong the lives of people with this type of the disease.”
Tecentriq, a PD-L1 blocking antibody, is already approved for the treatment of locally advanced or metastatic urothelial carcinoma, unresectable locally advanced or metastatic triple-negative breast cancer, metastatic non-squamous non-small cell lung cancer, and extensive-stage small cell lung cancer.
The Company is currently evaluating Tecentriq in 9 ongoing phase 3 studies for different types of lung cancer as well as additional phase 3 studies for genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.
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