NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for atezolizumab (Roche's Tecentriq) combined with chemotherapy as a first-line treatment of metastatic non-small cell lung cancer without EGFR mutations or ALK rearrangements.
CHMP based its decision on the results of the 700-patient Phase III Impower130 study, which showed patients receiving the atezolizumab combination regimen had significantly longer median overall survival than those just on chemotherapy, 18.6 months versus 13.9 months, respectively. Patients receiving the atezolizumab-containing regimen also experienced median progression-free survival of 7 months versus 5.5 months for those on chemotherapy alone.
Next, the European Commission will decide whether to approve atezolizumab in this indication based on CHMP's positive opinion.
In June, CHMP recommended the approval of atezolizumab plus chemotherapy for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer tumors with PD-L1 expression greater than one percent who have not previously received chemotherapy for metastatic disease.