Trial results for a combination of pembrolizumab (Keytruda) and autogene cevumeran (RO7198457) in participants with previously untreated advanced melanoma were posted on ClinicalTrials.gov on 2026-01-30. The Phase 2 study found no statistically significant improvement in progression-free survival for the combination arm, with a median PFS of 8.3 months compared to 7.9 months for pembrolizumab alone (Hazard Ratio: 0.79, p=0.3284).
Background
Pembrolizumab is an established immunotherapy used in the treatment of various cancers, including advanced melanoma. This study investigated whether combining autogene cevumeran (RO7198457) with pembrolizumab could offer additional efficacy for patients with previously untreated advanced melanoma.
Trial design
The completed Phase 2 study (NCT03815058) enrolled 131 participants with previously untreated advanced melanoma. The trial evaluated the efficacy and safety of two treatment arms:
- Arm A: Pembrolizumab alone
- Arm B: Pembrolizumab in combination with autogene cevumeran (RO7198457)
The study aimed to assess outcomes such as progression-free survival, objective response rate, and overall survival, among others.
Key results
Key efficacy and safety outcomes were measured:
- Progression-free Survival (PFS): The median PFS was 7.9 months for the pembrolizumab arm and 8.3 months for the pembrolizumab + autogene cevumeran arm. A Log Rank analysis yielded a Hazard Ratio of 0.79 (95.0% Confidence Interval: 0.49 to 1.27), with a p-value of 0.3284.
- Objective Response Rate (ORR): The ORR was 48.8 percentage of participants in the pembrolizumab arm, compared to 41.7 percentage of participants in the pembrolizumab + autogene cevumeran arm.
- Overall Survival (OS): Median OS was NA months for the pembrolizumab arm and 62.2 months for the pembrolizumab + autogene cevumeran arm.
- Global Health Status (GHS)/Health-related Quality of Life (HRQoL) Score: Mean scores for the pembrolizumab arm were 64.74 (Standard Deviation 24.67) and -1.85 (Standard Deviation 17.72). For the pembrolizumab + autogene cevumeran arm, mean scores were 73.39 (Standard Deviation 21.56) and 0.00 (Standard Deviation 0.00).
What this means
The results from this Phase 2 trial indicate that the addition of autogene cevumeran to pembrolizumab did not lead to a statistically significant improvement in progression-free survival for patients with previously untreated advanced melanoma, as evidenced by the p-value of 0.3284 for the Hazard Ratio. The objective response rate was also lower in the combination arm. While some quality of life scores showed higher mean values for the combination, the primary efficacy measures do not support an enhanced benefit from the combination therapy in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03815058, titled "A Study to Evaluate the Efficacy and Safety of Autogene Cevumeran (RO7198457) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Participants With Previously Untreated Advanced Melanoma," were posted on 2026-01-30 on clinicaltrials.gov.