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Roche Immunotherapy Combo Misses Progression-Free Survival Endpoint in First-Line NSCLC Trial

NEW YORK – Roche subsidiary Genentech on Wednesday said that PD-L1-high advanced non-small cell lung cancer patients who received first-line treatment with tiragolumab plus Tecentriq (atezolizumab) in a Phase III trial did not experience a statistically significant improvement in progression-free survival compared to those on single-agent Tecentriq.

Within the SKYSCRAPER-01 trial, Genentech is comparing its investigational anti-TIGIT immunotherapy tiragolumab and its PD-L1 inhibitor Tecentriq against just Tecentriq as a first-line option in 534 patients with PD-L1-high locally advanced or metastatic NSCLC. The trial has two co-primary endpoints: progression-free and overall survival. While the trial has failed to meet the former at this first analysis time point, overall survival data are still immature.

There was a numerical improvement in progression-free and overall survival with the tiragolumab-Tecentriq combination compared to Tecentriq alone. "The study will continue until the next planned analysis," Genentech said in a statement.

Roche had been anticipating this SKYSCRAPER-01 data readout, as executives were hoping it would confirm the benefit of the tiragolumab-Tecentriq combo in first-line PD-L1-positive advanced NSCLC — a profitable and competitive market. Bristol Myers Squibb’s dual immunotherapy combination, Opdivo (nivolumab) and Yervoy (ipilimumab), is a first-line option for metastatic NSCLC patients with PD-L1 expression in at least 1 percent of tumor cells.

Tiragolumab is designed to block TIGIT receptors on immune cells from linking with PVR on tumor cells, which is a mechanism that cancer cells use to hide from an immune system attack. Roche expects tiragolumab to work synergistically with Tecentriq and particularly benefit those with high-PD-L1 expression. The SKYSCRAPER-01 trial was started after researchers saw that NSCLC patients in the CITYSCAPE study with PD-L1 expression in at least 50 percent of tumor cells derived the most benefit from tiragolumab-Tecentriq.

"We continue to believe that TIGIT may have a role in cancer treatment, and we will share additional results from our tiragolumab program as they emerge," Levi Garraway, Genentech's chief medical officer and head of global product development, said in a statement.