EU approves Tecentriq plus chemo approved for small cell lung cancer

The European Commission has approved and granted marketing authorisation for Tecentriq (atezolizumab), from Roche, 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 approval 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 versus 10.3 months; hazard ratio [HR]=0.70, 95% CI: 0.54–0.91; p=0.0069) in the intention-to-treat (ITT) population. 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=0.77; 95% CI, 0.62–0.96; p=0.017).

Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq. Grade 3–4 treatment-related adverse events occurred in 56.6% of people receiving Tecentriq plus chemotherapy, compared with 56.1% of people receiving chemotherapy alone. The most common adverse reactions (at least 20%) in people receiving Tecentriq plus chemotherapy were low white blood cell count (neutropenia; 23%), anaemia (14%), decreased neutrophil count (14%) and thrombocytopenia (10%).