Roche’s Small Cell Lung Cancer Antibody Fails in Phase 3 Trial
In the Phase 3 clinical trial, small cell lung cancer patients who received the antibody did not achieve overall survival and are unlikely to reach statistical significance at the final analysis.
Roche recently announced that its monoclonal IgG1 antibody, tiragolumab, plus Tecentriq and chemotherapy, did not meet its co-primary endpoints in a Phase 3 extensive-stage small cell lung cancer (ES-SCLC) clinical trial.
The global SKYSCRAPER-02 study evaluated tiragolumab plus Tecentriq and chemotherapy as a first-line treatment versus Tecentriq and chemotherapy alone in 490 people with ES-SCLC. The co-primary endpoints were overall survival (OS) and progression-free survival (PFS).
Patients did not achieve overall survival and are unlikely to reach statistical significance at the planned final analysis. Therefore, data suggest that tiragolumab plus Tecentriq and chemotherapy were well-tolerated, and researchers identified no new safety signals when adding tiragolumab.
“Today’s outcome is disappointing as we had hoped to continue building on the advances of Tecentriq in extensive-stage small-cell lung cancer, which remains difficult to treat. We are thankful to all the patients and healthcare professionals involved in the study,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in the announcement.
“We look forward to seeing additional data from the upcoming phase III trial in PD-L1-high non-small cell lung cancer based on the encouraging results from the CITYSCAPE study,” Garraway continued.
Roche’s tiragolumab program will continue to explore advances in multiple clinical trials to build on Tecentriq, expand into earlier stages of the disease, and provide new treatment options in advanced and difficult-to-treat cancers with high unmet medical needs.
In February 2021, FDA granted tiragolumab breakthrough designation to treat metastatic non-small cell lung cancer (NSCLC) patients whose tumors have high levels of programmed death ligand-1 (PD-L1).
In the Phase 2 CITYSCAPE study, tiragolumab-treated patients saw a 37.3% ORR and 5.6-month median PFS versus 20.6% and 3.9 months in patients on the atezolizumab and placebo regimen.
SCLC is the most aggressive form of lung cancer, and Tecentriq was the first cancer immunotherapy to show a survival benefit in ES-SCLC. The drug was the first approved treatment option in 20 years.
