The Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab; Genentech), in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

The approval was based on data from the phase 3 IMpower133 study which evaluated the safety and efficacy of Tecentriq + chemotherapy vs chemotherapy alone in chemotherapy-naïve patients with ES-SLC (N=403). The co-primary efficacy outcomes of the study were overall survival (OS) and progression-free survival (PFS).

Results showed that patients treated with Tecentriq plus chemotherapy had significantly longer OS compared with those who received chemotherapy alone (12.3 vs 10.3 months; hazard ratio [HR] 0.70, 95% CI, 0.54–0.91; P=.0069). In addition, the combination therapy significantly reduced the risk of disease worsening or death (PFS 5.2 vs 4.3 months for chemotherapy alone; HR 0.77; 95% CI, 0.62–0.96; P=.017).

With regard to safety, the most common adverse reactions reported in ES-SCLC patients receiving Tecentriq plus chemotherapy were fatigue/asthenia, nausea, alopecia, decreased appetite, constipation, and vomiting. Serious adverse reactions occurred in 37% and 35% of patients treated with the combination therapy and monotherapy, respectively.

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“Tecentriq is the first cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer, which is especially difficult to treat,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “Until now, there have been limited treatment advances for this disease, and we are excited to bring a potential new standard of care to patients that has been shown to improve survival compared to chemotherapy.”

Tecentriq, a PD-L1 blocking antibody, is already indicated for the treatment of locally advanced or metastatic urothelial carcinoma, metastatic non-small cell lung cancer, and triple-negative breast cancer.

For more information visit Gene.com.