Roche Phase III study of tiragolumab in ES-SCLC misses

The Phase III SKYSCRAPER-02 study, evaluating the investigational anti-TIGIT immunotherapy tiragoluma  plus Tecentriq (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial (first-line) treatment for people with extensive-stage small cell lung cancer (ES-SCLC), did not meet its co-primary endpoint of progression-free survival, Swiss pharma giant Roche (ROG: SIX) announced today.

The co-primary endpoint of overall survival was not met at its interim analysis and is unlikely to reach statistical significance at the planned final analysis. Data suggest tiragolumab plus Tecentriq and chemotherapy was well-tolerated and no new safety signals were identified when adding tiragolumab. Data will be presented at an upcoming medical meeting.

“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,” said Dr Levi Garraway, chief medical officer and head of global product development, adding: “We look forward to seeing additional data from the upcoming phase III trial in PD-L1-high on-small cell lung cancer based on the encouraging results from the CITYSCAPE study.”

Tiragolumab in combination with Tecentriq has so far shown encouraging efficacy and safety in PD-L1-positive metastatic NSCLC based on data from the Phase II CITYSCAPE trial, the first randomized study in the anti-TIGIT field.