Regulatory Decision Summary for Tecentriq

The marketing authorization for Tecentriq for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) was based on results of a multicentre, randomized, double-blind, placebo controlled Phase I/III trial. Patients with chemotherapy-naïve ES-SCLC received a standard 4-cycle carboplatin and etoposide (CE) chemotherapy regimen in combination with either Tecentriq (n = 201) or placebo (n = 202), followed by Tecentriq or placebo monotherapy maintenance treatment. The study met its co-primary efficacy endpoints and demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) in patients treated with Tecentriq and CE compared with CE only. The OS improvement corresponds to a 30% lower risk of death and is considered clinically meaningful.

The addition of Tecentriq to the CE regimen was associated with increases in Grade 3 to 4 adverse events (AEs) (67.2% versus 63.8%), serious AEs (37.4% versus 34.7%) and AEs leading to treatment discontinuation (10.6% vs. 2.6%). In the Tecentriq arm, adverse reactions reported in the Tecentriq arm were generally consistent with the known safety profiles of Tecentriq, carboplatin and etoposide. Immune-mediated adverse reactions in the Tecentriq arm were mostly manageable using dose interruption and/or corticosteroids. These safety findings were adequately described in the revised Tecentriq product monograph (PM). An updated Risk Management Plan (RMP) was assessed and considered acceptable by Health Canada, which provides additional measures for risk monitoring and mitigation in the post-market setting.

Overall, the benefit and risk profile of Tecentriq in combination with carboplatin and etoposide is considered positive for the first-line treatment of adult patients with ES-SCLC.

The recommended dose of Tecentriq is 1200 mg with carboplatin and etoposide every 3 weeks for 4 cycles, followed by Tecentriq 1200 mg monotherapy maintenance every 3 weeks until loss of clinical benefit or unacceptable toxicity. Refer to the Tecentriq PM for details.

Health Canada had granted this submission priority review under the Priority Review of Drug Submissions policy.