Adjuvant Pembrolizumab Plus Cisplatin-Based Chemoradiation in Locally Advanced HNSCC: First Results From the Randomized Phase 2b ADRISK Trial

Announcer:
Welcome to DataPulse from ESMO 2025 on ReachMD. This activity, titled “Adjuvant Pembrolizumab Plus Cisplatin-Based Chemoradiation in Locally Advanced head and neck squamous cell carcinoma: First Results From the Randomized Phase 2b ADRISK Trial” is provided by Prova Education.

Dr. Tao:
Good morning. I'm Dr. Yungan Tao, radiation oncologist from Paris, France. I'm here in ESMO 2025 Berlin, Germany, and I'm pleased to present the result of the ADRISK study yesterday presented by Dr. Dietz.

And ADRISK study is a phase 2b randomized trial evaluating the addition of pembrolizumab to postoperative chemoradiotherapy for high-risk and intermediate-risk patients. And high risk is patients with positive margin and also extranodal extension. And the intermediate risk for this study is closed margin less than 5 mm.

And this phase 2 study with a primary endpoint evidence-free survival, and over 200 patients included in this phase 2 study, and median follow-up 30 months. And the main finding is EFS improved numerically but no significance, with hazard ratio 0.81, and OS also not significant with hazard ratio 0.83.

In fact, the study was a little underpowered because they included only 200 patients, and also the events—initial events was 100 events. Now, in fact, they analyzed at 62 events. And also this phase 2 trial included much more patients with HPV positive, about half the patients were HPV positive. And in this population, quite a few events. And in this study, the patient with HPV negative, especially CPS more than or equal to 10, probably more beneficial with hazard ratio 0.8, nearing significance.

In fact, even this study is negative, but it's aligned with the recent study, our GORTEC NIVOPOSTOP study, which included 680 patients with high-risk head and neck cancer, and only 5% with HPV positive. This study showed a significant improvement of DFS with hazard ratio 0.76.

And also this is comparable to another phase 3 study, KEYNOTE-689, which included more than 700 patients with also high-risk and interim-risk patients. And this study is also positive, with a significant improvement of EFS with hazard ratio for all patients, 0.73.

And despite the negative result of the ADRISK study, and I think the role of pembrolizumab anti–PD-1 is still maintained, supported by this study, and will be the standard care for the future.

Here in ESMO 2025, I'm Yungan Tao. Thank you for listening.

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Thank you for listening to this DataPulse from ESMO 2025 on ReachMD. This activity is provided by Prova Education. Thank you for listening.