What question did this study set out to answer?

This study aims to evaluate the safety and efficacy of dostarlimab monotherapy in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) expressing PD-L1.

May 29, 2026

Safety and efficacy of dostarlimab monotherapy as first-line treatment in programmed cell death-ligand 1–positive recurrent/metastatic head and neck squamous cell carcinoma: Results from a phase 2 trial.

Key Points

This study aims to evaluate the safety and efficacy of dostarlimab monotherapy in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) expressing PD-L1.
Multicenter, open-label, randomized, Phase 2 trial
Patients received dostarlimab 500 mg every 3 weeks until disease progression or unacceptable toxicity
Primary endpoint was investigator-confirmed objective response rate per RECIST v1.1.
Objective response rate was 27.3% overall and 42.4% for CPS ≥20
Median progression-free survival was 4.2 months overall and 7.8 months for CPS ≥20
Treatment-emergent adverse events occurred in 91% of patients, with 32% reporting grade ≥3 events.

Abstract

6037 Background: The use of immune checkpoint inhibitors (ICIs) in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) has improved patient outcomes and showed benefit in the perioperative setting. The GALAXIES H none were treatment related. Conclusions: Dostarlimab monotherapy showed encouraging antitumor activity, particularly in patients with a CPS ≥20, and a consistent safety profile in 1L R/M HNSCC that is comparable to other ICIs in HNSCC. Clinical trial information: NCT06062420 . Efficacy outcomes. Confirmed ORR per RECIST v1.1, n (%) 95% CI n=66 CPS ≥20 (n=33) 14 (42.4) 25.5, 60.8 CPS 1–19 (n=33) 4 (12.1) 3.4, 28.2 Overall 18 (27.3) 17.0, 39.6 Best response, n (%) n=66 Complete response 1 (1.5) Partial response 17 (25.8) Stable disease 23 (34.8) Progressive disease 17 (25.8) Not evaluable 8 (12.1) CI, confidence interval; CPS, combined positive score; ORR, objective response rate; RECIST, Response Evaluation Criteria in Solid Tumors.

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