Roche Announces First-Ever Five-Year Survival Data for Atezolizumab Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer

On September 10, Roche announced the results of the global Phase III clinical trial IMpower133 study and the IMbrella A extension study. In the IMbrella A extension study, 12% of patients had an OS exceeding 5 years after receiving atezolizumab combined with chemotherapy, marking a new milestone in this field.

The study results were presented at the 2023 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer (IASLC). This trial marks the first five-year patient survival report for first-line immunotherapy combined with chemotherapy in the field of extensive-stage small cell lung cancer.

The safety data of atezolizumab combined with chemotherapy in the IMpower133 trial was consistent with the known safety profile, with no new significant drug safety information identified.

Following the release of the primary results from the global Phase III clinical trial IMpower133 study in 2018, as of now [1], the combination of atezolizumab and chemotherapy has been approved in over 100 countries worldwide as an immunotherapy regimen for the first-line treatment of ES-SCLC.

Atezolizumab combination therapy has been recommended as a standard treatment in multiple global clinical practice guidelines, including the National Comprehensive Cancer Network (NCCN) guidelines, the European Society for Medical Oncology (ESMO) clinical practice guidelines, the Chinese Society of Clinical Oncology (CSCO) guidelines, the Chinese Guidelines for the Treatment of Stage Ⅳ Primary Lung Cancer, and the Chinese Medical Association's Guidelines for Clinical Diagnosis and Treatment of Lung Cancer.

In 2020, atezolizumab was approved in China for first-line treatment of extensive-stage small cell lung cancer. Since then, Roche has been actively collaborating with the government and all sectors of society through initiatives such as supporting city惠民insurance programs, striving to help more patients improve their access to innovative drugs, thereby addressing the unmet needs of Chinese lung cancer patients.

About the IMbrella A Study

IMbrellaA is an open-label, non-randomized, multicenter extension study designed to provide continued access to atezolizumab for patients who have completed Roche/Genentech-sponsored clinical trials based on atezolizumab, including participants from the IMpower133 study.

At the 2023 IASLC WCLC, treatment outcomes were reported for patients transitioning from the IMpower133 study to the IMbrella A study. At the conclusion of the IMpower133 study, patients in the IMpower133 experimental group had the option to transition to the IMbrella A study. A total of 18 patients moved from the IMpower133 study to the IMbrella A study; therefore, the small sample size should be considered when interpreting the data.

About the IMpower133 Study

IMpower133 is a Phase III, multicenter, double-blind, randomized placebo-controlled study evaluating the efficacy and safety of atezolizumab combined with chemotherapy (carboplatin and etoposide) versus chemotherapy alone (carboplatin and etoposide) in adult patients with ES-SCLC who have not received prior chemotherapy. The study randomly enrolled 403 patients in a 1:1 ratio, with one group receiving atezolizumab in combination with carboplatin and etoposide, and the other group receiving placebo in combination with carboplatin and etoposide. The co-primary endpoints are progression-free survival (PFS) based on RECIST v1.1 and overall survival (OS) in the intention-to-treat population.

With a median follow-up of 13.9 months, the survival time for ES-SCLC patients was prolonged in the atezolizumab plus chemotherapy group compared to the chemotherapy-alone group (OS=12.3 months vs. 10.3 months; HR=0.70, 95% CI: 0.54-0.91, p=0.0069). Compared with chemotherapy alone, the combination of atezolizumab also reduced the risk of disease progression or death (PFS=5.2 months vs. 4.3 months; HR=0.77; 95% CI: 0.62–0.96, p=0.017). The safety data for atezolizumab combined with chemotherapy were consistent with the known safety profile of atezolizumab.

Editor: Mu Mian

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