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FDA grants priority review to first-line Tecentriq-based regimen for small cell lung cancer
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The FDA granted priority review to atezolizumab in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer.
The action was based, in part, on data from the phase 3 IMpower133 study, which met its co-primary endpoints of OS and PFS in the initial treatment of 403 patients with extensive-stage small cell lung cancer.
Results showed the addition of atezolizumab (Tecentriq, Genentech/Roche) to carboplatin and etoposide extended OS (median, 12.3 months vs. 10.3 months; HR = 0.7; 95% CI, 0.54-0.91) in the intent-to-treat population. Further, 51.7% of patients assigned atezolizumab achieved 1-year OS compared with 38.2% of patients assigned chemotherapy alone.
Atezolizumab also prolonged median PFS (5.2 months vs. 4.3 months; HR = 0.77; 95% CI, 0.62-0.96) and was associated with a higher rate of 1-year PFS (12.6% vs. 5.4%).
Researchers observed no new safety signals with the combination. Grade 3 to grade 4 treatment-related adverse events occurred in 56.6% of patients assigned the atezolizumab combination and 56.1% of patients assigned chemotherapy alone.
“It’s been more than 20 years since there has been a new initial treatment option for extensive-stage small cell lung cancer that delivers a clinically meaningful survival benefit,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “We are working closely with the FDA to bring this Tecentriq-based regimen to people with this difficult-to-treat type of lung cancer as soon as possible.”
The FDA is expected to make a decision on this application by March 18, 2019.