CHMP recommends EU approval of Roche’s Tecentriq in combination with chemotherapy
Decision based on results from first Phase III study to show a cancer immunotherapy-based combination significantly improved overall survival (OS) and progression-free survival (PFS) in over 20 years Roche today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). This decision is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival [OS]=12.3 vs. 10.3 months; hazard ratio [HR]=0. CI: 0.54-0.91; p=0.0069) in the intention-to-treat (ITT) population.1 The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0. CI: 0.62-0.96; p=0. This is the first Phase III study to show that a cancer immunotherapy-based combination significantly improved OS and PFS in the first-line treatment of ES-SCLC. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.
