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ESMO 2025 | ADRISK: pembrolizumab plus adjuvant chemoradiation in HNSCC

Andreas Dietz, MD, PhD, University Hospital of Leipzig, Leipzig, Germany, discusses the Phase IIb ADRISK trial (NCT03480672), which evaluated pembrolizumab added to standard adjuvant cisplatin-based radiochemotherapy in patients with resected locally advanced head and neck squamous cell carcinoma (HNSCC). Although event-free and overall survival were not significantly improved, trends favored the pembrolizumab arm. Safety remained consistent with known profiles, supporting further evaluation of immunotherapy in the adjuvant HNSCC setting. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.

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Transcript

We had the opportunity to present the at-risk data of our study group, which is a big group with 16 centers in Germany and at-risk is a trial which investigates additional pembrolizumab as adjuvant treatment after a resectable locally advanced Renal cell carcinoma with intermediate and high risk. So it’s added to the standard of care chemoradiation and we would like to see whether this makes an impact or not...

We had the opportunity to present the at-risk data of our study group, which is a big group with 16 centers in Germany and at-risk is a trial which investigates additional pembrolizumab as adjuvant treatment after a resectable locally advanced Renal cell carcinoma with intermediate and high risk. So it’s added to the standard of care chemoradiation and we would like to see whether this makes an impact or not. And it was quite interesting to learn that we are gaining HPV positive patients in Germany as well. So when we started to conduct the trial, we had about 35% P16 positive advanced oral pharynx carcinomas. But currently in the trial, we saw 70% of them and half of the patients definitely were p16 positives and the outcome after three years was nearly 90 so it was unbelievably good after resection and adjuvant chemoradiation an outcome was fine and functional outcome was fine as well so it’s it’s a it’s a very good therapy we have there is no need for further escalation it’s more need for de-escalation to keep that high level but we saw in the group of non p16 positives which is oral pharynx non p16 positive oral cavity hypopharynx and larynx we saw a very mixed outcome and we saw a trend towards benefit of pembrolizumab , but it was not significant regarding primary endpoint event-free survival. Overall survival is too early, it didn’t translate in any significance, but we have to wait for the longer run outcome. One of the conclusions was that we didn’t harm patients with pembrolizumab , so toxicity was fine, no grade 5 toxicity. Toxicity wasn’t severely increased due to additional pembrolizumab , so it was feasible. And we have to start selecting patients. That was one of the outcomes of the discussion and the discussion we had in the panel, that we really have to learn that the P16 positive oropharyngeal carcinoma is a group which runs fantastically. So we have to look for the others and there is probably a space of improvement.

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