The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of atezolizumab as a first-line treatment for adults with metastatic non-small cell lung cancer whose tumors have PD-L1 expression with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.
According to a release from the manufacturer, the recommendation is based on data from the phase 3 IMpower110 study, which evaluated the drug as a monotherapy. Results of the study showed the treatment improved overall survival by 7.1 months compared to chemotherapy (median OS = 20.2 months vs. 13.1 months; HR 0.59, 95% CI: 0.40-0.89; p=0.106) in people with high PD-L1 expression (TC3 or IC3-wild-type).
“Today’s CHMP recommendation is a significant step forward in bringing a new chemotherapy-free treatment with flexible treatment schedules to people in Europe with certain types of lung cancer,” Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche said in a press release.
The safety profile during the Impower110 study was similar to what was already known about the treatment, with no new safety signals identified. Grade 3-4 treatment-related adverse events were reported in 12.9% of patients in the atezolizumab arm compared to 44.1% in the chemotherapy arm.
If approved, atezolizumab would be the first and only single-agent cancer immunotherapy with three dosing options. The options allow for delivery of the treatment every two, three, or four weeks.
In the US, the FDA has approved atezolizumab either alone or in combination for several cancer types including NSCLC, SCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer, hepatocellular carcinoma, and certain types of advanced melanoma.