Trial results for pembrolizumab (Keytruda) in the Phase 3 KEYNOTE-937 study (NCT03867084) were posted on ClinicalTrials.gov on 2026-04-24. The study, investigating adjuvant therapy for hepatocellular carcinoma (HCC), reported a higher number of participants experiencing adverse events and discontinuing treatment in the pembrolizumab arm compared to placebo, with no statistically significant improvement in quality of life scores.
Background
The KEYNOTE-937 study (MK-3475-937) evaluated pembrolizumab as an adjuvant therapy in participants with hepatocellular carcinoma (HCC) who had achieved complete radiological response following surgical resection or local ablation. The study aimed to assess if adjuvant pembrolizumab was superior to placebo in terms of recurrence-free survival (RFS) and overall survival (OS), though these specific outcomes are not detailed in the currently posted results.
Trial design
The KEYNOTE-937 study (NCT03867084) was a Phase 3, randomized, placebo-controlled trial that enrolled 959 participants. The study investigated pembrolizumab versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) who had achieved complete radiological response after surgical resection or local ablation. The primary hypotheses of the study were to evaluate recurrence-free survival (RFS) and overall survival (OS).
Key results
The trial results posted focused on safety and patient-reported quality of life outcomes. For adverse events (AEs):
- A total of 430 participants in the pembrolizumab group experienced an AE, compared to 397 participants in the placebo group.
- Discontinuation of study treatment due to an AE occurred in 58 participants receiving pembrolizumab, versus 17 participants in the placebo group.
Regarding patient-reported quality of life scores, assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) and the Hepatocellular Carcinoma Module (QLQ-HCC18), analyses showed no statistically significant differences between the groups:
- For the EORTC QLQ-C30 Combined Global Health Status (GHS) / Quality of Life (QoL) Scale Score, the mean difference between groups was -1.36 (95% Confidence Interval: -3.7 to 0.99), with a p-value of 0.2563.
- For the EORTC QLQ-C30 Physical Functioning Scale Score, the mean difference was -0.24 (95% Confidence Interval: -2.28 to 1.8), with a p-value of 0.8165.
- For the EORTC QLQ-C30 Role Functioning Scale Score, the mean difference was -0.22 (95% Confidence Interval: -2.89 to 2.45), with a p-value of 0.8714.
- For the EORTC QLQ-HCC18 Abdominal Swelling Scale Score, the mean difference was 1.34 (95% Confidence Interval: -1.24 to 3.92), with a p-value of 0.3091.
All reported p-values for these quality of life outcomes were greater than 0.05, indicating no statistically significant differences between the pembrolizumab and placebo groups.
What this means
The posted results from the KEYNOTE-937 trial indicate that pembrolizumab as adjuvant therapy for HCC was associated with a higher incidence of adverse events and treatment discontinuations compared to placebo. Furthermore, the analysis of several patient-reported quality of life measures did not show a statistically significant benefit for pembrolizumab over placebo. These findings, particularly regarding the safety profile and lack of QoL improvement, are important considerations for clinicians, although the primary efficacy endpoints of recurrence-free survival and overall survival were not included in this data release.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03867084, titled "Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma (HCC) and Complete Radiological Response After Surgical Resection or Local Ablation (MK-3475-937 / KEYNOTE-937)," were posted on 2026-04-24 on clinicaltrials.gov.