Roche anti-TIGIT drug fails late-stage study

March 30, 2022

Roche’s Genentech had disappointing news to share this week regarding its lung cancer hopeful.

The phase 3 study, SKYSCRAPER-02, which evaluated Genentech's investigational anti-TIGIT immunotherapy as first-line treatment for patients with stage small-cell lung cancer (SCLC), failed to meet the co-primary endpoint of progression-free survival. SKYSCRAPER-02 was a global placebo-controlled and double-blinded study that included 490 people with SCLC.

“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 Levi Garraway, chief medical officer and head of Global Product Development for Roche. “We look forward to seeing additional data from the upcoming phase 3 trial in PD-L1-high non-small cell lung cancer based on the encouraging results from the CITYSCAPE study."

The other co-primary endpoint of overall survival wasn’t met either, and the data suggests that results probably won’t have statistical significance.  The study found that tiragolumab plus Tecentriq and chemotherapy were well-tolerated and no new safety signals were identified when adding tiragolumab.

SCLC is characterized by rapid progression and poor survival. Tecentriq was the first cancer immunotherapy to show a survival benefit and was the first approved treatment option in 20 years. Despite their recent setbacks, Genentech says they remain committed to exploring innovative medicines to improve outcomes for people with lung cancer.