Immunotherapy Plus Hypofractionated Radiotherapy Fails to Improve Survival for Treatment-Naive Melanoma
According to results from a phase 2 trial, immunotherapy plus hypofractionated radiotherapy did not improve survival among patients with treatment-naive metastatic melanoma.
“Radiotherapy is thought to enhance anti-tumor immunity, particularly when delivered in a hypofractionated and multisite manner,” stated Jerome Doyen, MD, PhD, University Hospital Center, Nice, France, and coauthors. “We investigated the effects of combining radiotherapy with nivolumab in patients with advanced melanoma.”
In this multicenter, non-randomized study, 64 patients with treatment-naive metastatic melanoma received 240 mg of nivolumab once every 2 weeks plus 6 Gy x 3 of radiotherapy on day 15. One (n = 37) or multiple (n = 27) targets from each organ was irradiated when necessary. The primary end point was overall survival (OS). Key secondary end points included progression-free survival (PFS) and safety.
At a median follow-up of 23.5 months, the 2-year OS rate was 65.2% (vs 58% in the CheckMate 066 trial; P = .22). The 1-year PFS rate was 56% (vs 43% in CheckMate 066; P = .03). Performance status was found to be an independent prognostic factor for OS (hazard ratio [HR], 3.5; P = .005) and irradiating more than 1 site and a smaller cumulative tumor volume were associated with better outcomes. Grade 3/4 treatment-related adverse events occurred in 21.9% of patients. No grade 5 events were reported.
“Combined immunotherapy and hypofractionated radiotherapy did not improve survival compared to historical cohorts,” concluded Dr Doyen et al. “The radiotherapy schedule needs to be optimized in order to improve these results.”
Source:
Doyen J, Dompmartin A, Cruzel C, et al. Nivolumab and hypofractionated radiotherapy in patients with advanced melanoma: A phase 2 trial. Eur J Cancer. Published online: January 22, 2025. doi: 10.1016/j.ejca.2025.115256
