FDA Approves Atezolizumab Again for mNSCLC

Nick Mulcahy

December 04, 2019

The US Food and Drug Administration (FDA) approved atezolizumab (Tecentriq, Genentech/Roche) in combination with chemotherapy nab-paclitaxel (Abraxane, Celgene) and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK mutations, according to a company news release.

Atezolizumab was previously approved as an initial treatment for this same patient population, but in combination with bevacizumab (Avastin, Genentech/Roche), paclitaxel, and carboplatin.

In March, atezolizumab made headlines as the first drug to be approved in 20 years for the initial treatment of extensive-stage small cell lung cancer, as reported by Medscape Medical News.

The latest approval is based on efficacy and safety data from the phase 3 IMpower130 study, which showed that atezolizumab plus chemotherapy yielded a statistically significant benefit in overall survival and progression-free survival (PFS) compared to chemotherapy alone.

Patients randomly assigned to the atezolizumab-plus-chemotherapy arm had longer overall survival compared to patients in the chemotherapy-alone arm (median overall survival, 18.6 vs 13.9 months; hazard ratio [HR] = 0.80; 95% confidence interval [CI], 0.64 – 0.99; P = .038) in the intention-to-treat wild-type (ITT-WT) population.

The atezolizumab-plus-chemotherapy combination also provided superior PFS compared with chemotherapy alone (median PFS, 7.2 vs 6.5 months; HR, 0.75; 95% CI: 0.63 – 0.91; P = .002) in the same ITT-WT population.

Grade 3–4 treatment-related adverse events were reported in 73.2% of patients who received atezolizumab plus chemotherapy, vs 60.3% of patients who received chemotherapy alone.

No new safety signals were identified with the combination, according to the company release.

Atezolizumab is also approved by the FDA to treat adults with metastatic NSCLC who experience disease progression during or following platinum-containing chemotherapy.

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