Genentech announced positive results from the phase III IMpower133 study of Tecentriq (atezolizumab) plus carboplatin and etoposide for the initial treatment of people with previously-untreated extensive-stage small cell lung cancer.
Genentech is a member of the Roche Group.
The analysis showed that Tecentriq and chemotherapy helped people live significantly longer compared with chemotherapy alone (overall survival = 12.3 versus 10.3 months; hazard ratio = 0.70, 95 percent CI: 0.54-0.91; p=0.0069) in the intention-to-treat population.
The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival) compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77, 95 percent CI: 0.62-0.96; p=0.017). Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.
The data was presented at the International Association for the Study of Lung Cancer 2018 World Conference on Lung Cancer Presidential Symposium. The data will be simultaneously published in the New England Journal of Medicine.
IMpower133 is a phase III, multicenter, double-blinded, randomized placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve people with ES-SCLC.
The study enrolled 403 people who were randomized equally (1:1) to receive:
Tecentriq in combination with carboplatin and etoposide (Arm A), or
Placebo in combination with carboplatin and etoposide (Arm B, control arm)
During the treatment-induction phase, people received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed.
The co-primary endpoints were:
PFS as determined by the investigator using RECIST v1.1 in the ITT population
OS in the ITT population
Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. Grade III-IV treatment-related adverse events were reported in 56.6 percent of people receiving Tecentriq plus chemotherapy compared to 56.1 percent of people receiving chemotherapy alone.
