SKYSCRAPER-06 Study of Tiragolumab Plus Atezolizumab in Nonsquamous NSCLC Intended to Halt

By Cecilia Brown - Last Updated: July 12, 2024

The phase 2/3 SKYSCRAPER-06 study did not meet its primary end points of progression-free survival (PFS) and overall survival (OS), according to an announcement from Genentech, a member of the Roche Group. Company officials said they “intend to halt the study” based on these results and will unblind patients and investigators.

Advertisement

“A communication will be sent to the investigators, and results will be shared with health authorities and subsequently presented at an upcoming medical meeting,” officials said in the announcement.

The study has been comparing first-line tiragolumab plus atezolizumab (Tecentriq) and chemotherapy with pembrolizumab and chemotherapy in previously untreated, locally advanced unresectable or metastatic nonsquamous non-small cell lung cancer (NSCLC). The global study was a randomized, placebo-controlled, and double-blinded trial that included 542 patients with nonsquamous NSCLC.

“The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy in both PFS and OS compared [with] the comparator arm in the intent-to-treat population, which includes phase 2 and phase 3 cohorts,” according to the announcement. “The overall safety profile remains consistent with the safety profile previously observed for the combination of tiragolumab plus Tecentriq and chemotherapy, and no new or unexpected findings were identified.”

The primary analysis of PFS in the study showed a hazard ratio (HR) of 1.27 (95% CI, 1.02-1.57). The first interim analysis of OS was immature but showed an HR of 1.33 (95% CI, 1.02-1.73).

“These results are disappointing, as it was our hope that this combination might yield improved outcomes for people living with metastatic nonsquamous lung cancer,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, said in a statement. “We are thankful to all of the patients and health care professionals involved in the study, and we will leverage the learnings to inform our scientific understanding of the anti-TIGIT pathway and new avenues in cancer research.”

Source: Genentech

Advertisement