FDA grants breakthrough therapy designation to tiragolumab, Tecentriq for NSCLC subset

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The FDA granted breakthrough therapy designation to tiragolumab combined with atezolizumab for the first-line treatment of patients with metastatic non-small cell lung cancer.

This indication for tiragolumab (Roche) — an immunotherapy designed to bind to TIGIT, a protein receptor on immune cells — and atezolizumab (Tecentriq, Genentech/Roche), an anti-PD-L1 agent, applies to patients whose tumors have high PD-L1 expression and no EGFR or ALK mutations.

multicolored lungs on black background — *Source: Adobe Stock.*

The agency based this decision, in part, on data from the phase 2 CITYSCAPE trial, results of which were presented during the ASCO20 Virtual Scientific Program. The trial showed encouraging activity for targeting both PD-L1 and TIGIT, with a higher overall response rate (37% vs. 21%) and a 42% improvement in PFS with the combination compared with atezolizumab alone.

Results of an exploratory analysis of patients with high PD-L1 expression, defined as a tumor proportion score of 50% or higher, showed a clinically meaningful improvement in ORR (66% vs. 24%) and median PFS (not reached vs. 4.11 months; HR = 0.3; 95% CI, 0.15-0.61) with the combination.

The combination also appeared well-tolerated, with similar rates of grade 3 or worse adverse events in both groups (48% vs. 44%).

“We have been researching TIGIT as a novel cancer immunotherapy target for almost 10 years, and we are pleased that the FDA has acknowledged the potential of tiragolumab to substantially improve outcomes for people with certain types of lung cancer,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development, said in a press release. “We look forward to advancing our tiragolumab development program, which includes chemotherapy-free combinations and trials in early stages of disease across multiple cancer types with high unmet need.”

Trials are ongoing to assess tiragolumab in metastatic NSCLC and small cell lung cancer, stage III NSCLC, locally advanced and metastatic esophageal cancer, and cervical cancer.

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