Roche’s tiragolumab, when combined with its PD-L1 blocker Tecentriq, did not significantly improve progression-free and overall survival versus Keytruda and chemotherapy in patients with non-small cell lung cancer.
Roche on Thursday announced that it will stop the Phase II/III SKYSCRAPER-06 study following disappointing data from its investigational anti-TIGIT antibody tiragolumab, which was unable to significantly improve survival in patients with non-small cell lung cancer.
The pivotal study, which enrolled 524 patients with non-squamous non-small cell lung cancer (NSCLC), tested an investigational regimen combining tiragolumab with Roche’s PD-L1 blocker Tecentriq (atezolizumab) in the first-line setting. For the control, the pharma used a combination of Merck’s Keytruda (pembrolizumab) and chemotherapy.
At the time of the primary analysis, the tiragolumab regimen showed “reduced efficacy” in progression-free survival (PFS) with a hazard ratio of 1.27 in favor of the Keytruda arm. Overall survival (OS) data, which were not mature at the time of the analysis, also leaned in favor of Merck’s blockbuster with a hazard ratio of 1.33.
In terms of safety, SKYSCRAPER-06 found no new signals of concern with adverse events consistent with what had previously been established for tiragolumab and Tecentriq.
Roche CMO Levi Garraway in a statement said that the company found the results “disappointing,” adding that “it was our hope that this combination might yield improved outcomes” in metastatic non-squamous NSCLC. The pharma will coordinate the study’s termination with its investigators and will present full findings and analyses from the study at an upcoming medical congress.
Tiragolumab is an investigational antibody that works by targeting TIGIT, an immune receptor found on certain immune cells, which cancer cells can exploit to weaken the body’s anti-cancer activity. Tiragolumab’s mechanism of action allows it to instead amplify the immune response and acts in a complementary manner to the popular PD-L1 blockers.
Roche is also studying tiragolumab in small cell lung cancer, cervical cancer, esophageal cancer, head and neck cancer and other heme and solid tumors. In January 2024, the pharma reported that tiragolumab plus Tecentriq and chemotherapy led to a significant improvement in PFS in patients with esophageal squamous cell carcinoma, compared with chemo alone.
The combination treatment also improved OS, Roche said at the time.
Based on the readout from SKYSCRAPER-06, Roche will assess if it needs to make any changes to its other clinical development programs.
In April 2024, Roche won the FDA’s approval to use Alecensa (alectinib) for the adjuvant treatment of early-stage NSCLC positive for ALK mutations. The drug is the first-ever ALK inhibitor to be approved for this indication.
