ASCO 2026 | Phase II study of ipatasertib plus pembrolizumab for first-line treatment of R/M HNSCC
Jacob Thomas, MD, University of Southern California, Los Angeles, CA, discusses the results of a randomized Phase II study (NCT05172258) comparing single-agent pembrolizumab to pembrolizumab with ipatasertib, an oral AKT inhibitor, in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), highlighting that the response rate improved to 41% with the combination compared to 17% with single-agent pembrolizumab. This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
So single-agent pembrolizumab is the standard of care for a recurrent metastatic head and neck squamous cell carcinoma. Historically, response rates are very modest, 19%. And so there’s been efforts to improve upon that over the past several years. So our study is one of those efforts. It was a randomized phase two study with a comparator arm of single-agent pembrolizumab comparing to a combination arm of pembrolizumab plus ipatasertib...
So single-agent pembrolizumab is the standard of care for a recurrent metastatic head and neck squamous cell carcinoma. Historically, response rates are very modest, 19%. And so there’s been efforts to improve upon that over the past several years. So our study is one of those efforts. It was a randomized phase two study with a comparator arm of single-agent pembrolizumab comparing to a combination arm of pembrolizumab plus ipatasertib. Ipatasertib is an oral AKT inhibitor. It was dosed on days 1 to 14 of a 21-day cycle. What we saw is that the response rate improved to 41% with the combination compared to 17% in the single agent arm, which tracks with historical data. So this is exciting. It’s a small study, only 52 patients. So further study needs to be done to identify whether there’s a subset that would benefit from this. but we’re very excited for these results.
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