FDA approves Roche?s Tecentriq in combination with chemotherapy for the initial treatment of adults with extensive-stage small cell lung cancer
- Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
- First new initial treatment option approved by FDA for people with ES-SCLC in more than 20 years
About the IMpower133 study
IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) vs. chemotherapy (carboplatin and etoposide) alone in chemotherapy-na?ve adults with ES-SCLC. The study enrolled 403 people who were randomised 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)
- Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (OS=12.3 vs. 10.3 months; HR=0.70, 95% CI: 0.54-0.91; p=0.0069) in the ITT population.
- The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared to chemotherapy alone (PFS=5.2 vs. 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. Serious adverse reactions occurred in 37% of people receiving Tecentriq plus chemotherapy compared to 35% of people receiving chemotherapy alone. The most common adverse reactions (=20%) in people receiving Tecentriq plus chemotherapy were feeling tired or weak (fatigue/asthenia; 39%), nausea (38%), hair loss (alopecia; 37%), decreased appetite (27%) and constipation (26%) and vomiting (20%).