Roche’s Tiragolumab Faces Setback in Lung Cancer Trial

Roche’s tiragolumab continues to struggle in the cancer treatment space. The latest failure occurred in the Phase III SKYSCRAPER-01 trial. This trial tested tiragolumab with Tecentriq in patients with PD-L1-high, advanced non-small cell lung cancer (NSCLC). Unfortunately, the study failed to show a survival benefit, falling short of its primary endpoint.

The trial enrolled 534 patients in a randomised, double-blind design. Roche compared the combination of tiragolumab and Tecentriq to a placebo with Tecentriq. Despite initial hope, tiragolumab did not improve overall survival (OS) in this patient group. This marks another disappointment for Roche, following a series of similar results in previous trials.

Previously, tiragolumab showed limited benefits in the SKYSCRAPER-01 trial. It did not demonstrate a significant progression-free survival (PFS) advantage compared to Tecentriq alone. Patients receiving the combination had a median PFS of 5.4 months, versus 4.8 months for those receiving only Tecentriq. This was far below expectations for the anti-TIGIT therapy.

The immune checkpoint inhibitor tiragolumab targets the TIGIT receptor, which typically suppresses the immune response to cancer. It is designed to enhance the immune system’s ability to fight tumors. However, these recent setbacks raise questions about the therapy’s role in lung cancer treatment.

Roche’s challenges with tiragolumab are compounded by other recent trial failures. In 2022, the drug did not meet PFS or OS endpoints in the SKYSCRAPER-02 trial involving small-cell lung cancer patients. Moreover, the SKYSCRAPER-06 trial also missed its primary endpoints when compared to Keytruda. These failures have prompted Roche to reevaluate its study programs and consider adjustments.

In contrast, GSK and iTeos have seen success in this field. Their collaboration, combining Jemperli and belrestotug, recently delivered positive Phase II data in NSCLC. This success has spurred them to advance their research with a Phase III trial. Roche will need to address its shortcomings as it continues to refine tiragolumab’s potential for cancer patients.

Roche remains committed to refining its approach. It will analyze additional data from ongoing studies and other tumor types in the coming year.