Roche today announced that the US Food and Drug Administration (FDA) approved Tecentriq^® (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), 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 3 IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared to chemotherapy alone (median overall survival [OS] 12.3 vs 10.3 months; hazard ratio [HR]=0.70, 95% confidence interval [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 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.

“Tecentriq is the first cancer immunotherapy approved for the initial treatment of extensive-stage small cell lung cancer, which is especially difficult to treat,” said Sandra Horning, MD, Roche’s chief medical officer and head of global product development. “Until now, there have been limited treatment advances for this disease, and we are excited to bring a potential new standard of care to patients that has been shown to improve survival compared to chemotherapy."

Results from the phase 3 IMpower133 study were simultaneously presented at the 2018 World Conference on Lung Cancer (WCLC) and published in The New England Journal of Medicine.

In the United States, Tecentriq is approved in combination with Avastin^® (bevacizumab), paclitaxel, and carboplatin (chemotherapy), for the initial (first-line) treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. In Europe, the Tecentriq and Avastin combination is approved for the initial treatment of people with metastatic non-squamous NSCLC, including people with EGFR mutant or ALK genomic tumor aberrations after failure of appropriate targeted therapies. Tecentriq is also approved by the FDA to treat adults with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq.

About the IMpower133 study

IMpower133 is a phase 3, multicenter, double-blinded, randomized, 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-naïve 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)

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 (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumours 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 and OS in the ITT population. A summary of the ITT data from the IMpower133 study that support this approval is included below.

• 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%)