ESMO Immuno-Oncology 2025 | SKYSCRAPER-09: atezolizumab and tiragolumab in head and neck cancer
Amanda Psyrri, MD, PhD, FACP, National Kapodistrian University of Athens, Athens, Greece, comments the results of the Phase II SKYSCRAPER-09 study (NCT04665843) of atezolizumab and tiragolumab in patients with PD-L1 positive head and neck cancer. The statistical threshold for improvement in objective response rate was not met, but patients with high PD-L1 expression who received the combination therapy had numerically prolonged overall survival. Additional trials that did not meet its endpoint include the ASPEN-04 (NCT04675333), ASPEN-03 (NCT04675294) trials. This interview took place at 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress in London, UK.
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Transcript
At ESMO, this year, I presented the results of Skyscraper09. Skyscraper09 was a randomized phase 2 study. It was a randomized non-comparative study. Patients with PD-L1 positive, regarding the study, had an extremal cell carcinoma, were randomized two to one between atezolizumab and tiragolumab. Tiragolumab is an anti-TIGIT inhibitor and atezolizumab plus placebo. The study was not powered for an efficient comparison between the two arms...
At ESMO, this year, I presented the results of Skyscraper09. Skyscraper09 was a randomized phase 2 study. It was a randomized non-comparative study. Patients with PD-L1 positive, regarding the study, had an extremal cell carcinoma, were randomized two to one between atezolizumab and tiragolumab. Tiragolumab is an anti-TIGIT inhibitor and atezolizumab plus placebo. The study was not powered for an efficient comparison between the two arms. The primary endpoint was overall response rate per investigator review. Patients had to have treatment-naive metastatic disease. Secondary endpoints included duration of response, PFS, and overall survival. So the combination of anti-TD-1 with anti-TIGIT failed to meet the statistical threshold for improvement in objective response rate. Patients with PD-L1 expression 20 or higher had a numerically prolonged overall survival, whereas this effect was not observed in the atezolizumab alone arm. So patients who received atezolizumab in the atezolizumab and tiragolumab arm and had PD-L1 higher had numerically prolonged overall survival. This effect was not observed in atezo with high PD-L1 expression. Other combinations that were presented at ESMO, they were two phase two studies with CD47 blockade. The first study, ASPEN-03, was evorpacept with a CD47 inhibitor versus pembrolizumab alone in PD-L1 positive recurrent metastatic in first-line settings. The primary endpoint was overall response rate. A positive signal was not detected there. And also ASPEN-04 studied CD47 blockade with pembrolizumab plus 5FU compared to pembrolizumab plus platinum 5FU. And again, the overall response rate was the primary endpoint, which did not meet the statistical threshold for improvement. So several phase two combination studies have been reported at ASCO and ESMO. The CD30 targeting antibody combined with pembrolizumab in PD-L1-positive disease demonstrated an overall response rate of 34%, warranting further investigation.
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