SKYSCRAPER-1 Trial Does Not Meet End Point of PFS With Tiragolumab Plus Atezolizumab in NSCLC

The primary end point of progression-free survival was not met in the phase 3 SKYSCRAPER-1 trial assessing tiragolumab plus atezolizumab for patients with PD-L1–high locally advanced or metastatic non–small cell lung cancer.

Interim results from the phase 3 SKYSCRAPER-01 study (NCT04294810), assessing tiragolumab plus atezolizumab (Tecentriq) vs atezolizumab alone for patients with PD-L1–high locally advanced or metastatic non–small cell lung cancer, did not meet the co-primary end point of progression-free survival (PFS), according to a press release from Roche.

Additionally, investigators indicated that data for the co-primary end point of overall survival (OS) were immature; however, the study is planned to continue until the next planned analysis. Investigators noted that both end points had numerical improvement, and no new safety signals were observed with the addition of tiragolumab.

The trial enrolled 534 patients who were randomized 1:1 to receive either tiragolumab, an anti-T cell immunoreceptor with Ig and ITIM domain (TIGIT) immunotherapy agent, plus atezolizumab or placebo plus atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity.

“While these results are not what we hoped for in our first analysis, we look forward to seeing mature [OS] for this study to determine next steps,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Roche, said in the press release. “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.”

Patients in the experimental arm received 1200 mg of atezolizumab intravenously every 3 weeks on day 1 of each 21-day cycle, and 600 mg of tiragolumab intravenously every 3 weeks. The same atezolizumab backbone was given to the control group. Secondary end points from the study included investigator-assessed PFS in the secondary analysis, OS in the secondary analysis, investigator-assessed confirmed objective response rate, and investigator-assessed duration of response.

Inclusion criteria included having ECOG performance status of 0 or 1, and histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy. Additional inclusion criteria included having no prior systemic treatments, high tumor tissue PD-L1 expression, and adequate hematologic and end-organ function.

Those with a known mutation in the EGFR gene or an ALK fusion oncogene; symptomatic, untreated, or progressing central nervous system metastases; and active or a history of autoimmune disease or immune deficiency were excluded from the study.

The study will continue to the next planned analysis.

Reference

Roche reports interim results for the phase III SKYSCRAPER-01 study in PD-L1-high metastatic non–small cell lung cancer. News Release. May 11, 2022. Accessed May 11, 2022. https://bit.ly/39e8QY4