Roche has shared a positive interim analysis following what the company says was an "inadvertent disclosure" of the data from a closely-watched phase 3 study of its investigational anti-TIGIT immunotherapy in non-small cell lung cancer (NSCLC).
The SKYSCRAPER-01 trial is a global randomized double-blinded study evaluating tiragolumab plus Tecentriq versus Tecentriq alone in 534 patients with first-line PD-L1-high locally advanced, unresectable or metastatic NSCLC.
Although Roche says the results were "not mature" at the time of the second interim analysis, data showed median overall survival estimates of 22.9 months in the tiragolumab plus Tecentriq arm and 16.7 months in the Tecentriq monotherapy arm, yielding an overall survival hazard ratio of 0.81. Essentially, patients on tiragolumab had a 19% lower mortality rate than those in the group without the drug.
This is better news than the phase 3 SKYSCRAPER-02 study yielded. That study — which tested tiragolumab plus Tecentriq and chemotherapy as a first-line treatment for people with extensive-stage small cell lung cancer — failed to meet the co-primary endpoints of progression-free survival or overall survival.
Tiragolumab is a novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint, which suppresses the immune response to cancer. Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq.
According to Roche, the SKYSCRAPER-01 trial is ongoing and the study remains blinded to patients and investigators.