Trial results comparing nivolumab to lomvastomig and tobemstomig in advanced or metastatic esophageal squamous cell carcinoma were posted on ClinicalTrials.gov on 2026-03-27. The study found that nivolumab demonstrated a median overall survival of 8.08 months, compared to 4.76 months for lomvastomig and 6.67 months for tobemstomig.
Background
The study investigated treatments for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC), a challenging cancer for which effective therapies are crucial.
Trial design
This Phase II, randomized, blinded, active-controlled, global, multicenter study (NCT04785820) was designed to evaluate the safety and efficacy of lomvastomig and tobemstomig compared with nivolumab. The trial enrolled 190 participants with Advanced or Metastatic Esophageal Squamous Cell Carcinoma who were refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimens. Recruitment into the lomvastomig arm was stopped based on strategic considerations, not safety or efficacy.
Key results
The trial evaluated several key outcomes:
- Overall Survival (OS):
- Nivolumab arm: Median OS was 8.08 months.
- Lomvastomig arm: Median OS was 4.76 months.
- Tobemstomig arm: Median OS was 6.67 months.
- Objective Response Rate (ORR):
- Nivolumab arm: 8.6 percentage of participants.
- Lomvastomig arm: 3.7 percentage of participants.
- Tobemstomig arm: 9.8 percentage of participants.
- Disease Control Rate (DCR):
- Nivolumab arm: 43.2 percentage of participants.
- Lomvastomig arm: 29.6 percentage of participants.
- Tobemstomig arm: 41.5 percentage of participants.
- Adverse Events (AEs):
- Nivolumab arm: 69 Participants experienced AEs.
- Lomvastomig arm: 25 Participants experienced AEs.
- Tobemstomig arm: 76 Participants experienced AEs.
Key analyses included:
- A Log Rank analysis comparing overall survival yielded a Hazard Ratio of 1.05 (80% CI: 0.84-1.33) with a p-value of 0.7689.
- Another Log Rank analysis yielded a Hazard Ratio of 0.89 (80% CI: 0.71-1.11) with a p-value of 0.4942.
- A Cochran-Mantel-Haenszel analysis for Objective Response Rate yielded an Odds Ratio of 1.12 (80% CI: 0.55-2.27) with a p-value of 0.8367.
- The Difference in Overall Response Rates was 1.11 (80% CI: -4.69-6.91) with a p-value of 0.8367.
What this means
The results indicate that nivolumab demonstrated numerically higher median overall survival compared to both lomvastomig and tobemstomig in this population of participants with advanced or metastatic esophageal squamous cell carcinoma. While tobemstomig showed a numerically higher objective response rate than nivolumab, the statistical analyses for both overall survival and objective response rate did not show statistically significant differences between the treatment arms. The decision to stop recruitment for the lomvastomig arm was based on strategic considerations rather than safety or efficacy, as noted in the trial summary.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04785820, titled "A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus," were posted on 2026-03-27 on clinicaltrials.gov.