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FDA approves frontline Tecentriq plus chemotherapy for extensive-stage small cell lung cancer
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The FDA today approved atezolizumab plus carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer.
Atezolizumab (Tecentriq, Genentech/Roche) — a monoclonal antibody that binds with PD-L1 to block its interactions with PD-1 and B7.1 receptors — plus chemotherapy is the first new frontline treatment option approved for these patients in more than 20 years.
“Tecentriq is the first cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer, which is especially difficult to treat,” Sandra Horning, MD, chief medical officer and head of global product development at Roche, said in a press release. “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.”
The approval was based, in part, on data from the multicenter, double-blind phase 3 IMpower133 study, researchers of which randomly assigned 403 treatment-naive patients with extensive-stage small cell lung cancer 1:1 to 1,200 mg atezolizumab or placebo on day 1 with carboplatin (area under the curve 5 mg/mL/min on day 1) and etoposide (100 mg/m2 IV on days 1, 2 and 3 of each 21-day cycle for four cycles). Following the first four cycles, patients received 1,200 mg atezolizumab or placebo once every 3 weeks until progression or unacceptable toxicity.
As HemOnc Today previously reported, data from the trial showed the combination of atezolizumab and chemotherapy significantly extended median OS in the intention-to-treat population compared with chemotherapy alone (12.3 months vs. 10.3 months; HR = 0.7; 95% CI, 0.54-0.91).
The combination also conferred longer median PFS (5.2 months vs. 4.3 months; HR = 0.77; 95% CI, 0.62-0.96).
Serious adverse events occurred in 37% of patients receiving atezolizumab plus chemotherapy and 35% of patients receiving chemotherapy alone. The most common adverse events that occurred in at least 20% of patients who received atezolizumab included fatigue/asthenia (39%), nausea (38%), alopecia (37%), constipation (26%), decreased appetite (27%) and vomiting (20%).
This application previously received FDA priority review designation.