Results from a Phase 2 trial investigating coformulated pembrolizumab/quavonlimab (MK-1308A) in combination with lenvatinib (E7080/MK-7902) for advanced hepatocellular carcinoma were posted on 2026-06-23. The study reported a median overall survival of 21.0 months and an objective response rate of 38.3%. Notably, zero dose-limiting toxicities were observed in the safety lead-in phase.
Background
The study investigated the combination therapy for advanced hepatocellular carcinoma, a condition for which new treatment options are continually being explored.
Trial design
This was a Phase 2 trial (NCT04740307) that enrolled 116 participants. The study focused on evaluating the safety and efficacy of the coformulated pembrolizumab/quavonlimab plus lenvatinib in a first-line setting for advanced hepatocellular carcinoma. The trial's design did not involve hypothesis testing.
Key results
The trial reported several key measurements for the pembrolizumab/quavonlimab + lenvatinib arm:
- Number of participants with a dose-limiting toxicity (DLT) in the safety lead-in phase: 0 participants.
- Number of participants with at least one adverse event (AE): 114 participants.
- Number of participants with at least one serious adverse event (SAE): 52 participants.
- Number of participants with at least one immune-related AE (irAE): 55 participants.
- Number of participants with at least one hepatic AE: 17 participants.
- Number of participants discontinuing study treatment due to an AE: 31 participants.
- Objective Response Rate (ORR) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR): 38.3%.
- Duration of Response (DOR) per RECIST 1.1 as assessed by BICR: Median of 12.4 months.
- Disease Control Rate (DCR) per RECIST 1.1 as assessed by BICR: 79.1%.
- Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR: Median of 8.2 months.
- Time-To-Progression (TTP) per RECIST 1.1 as assessed by BICR: Median of 8.5 months.
- Overall Survival (OS): Median of 21.0 months.
What this means
The results from this Phase 2 study suggest that the combination of coformulated pembrolizumab/quavonlimab and lenvatinib demonstrates promising efficacy and a manageable safety profile in patients with advanced hepatocellular carcinoma. The observed median overall survival of 21.0 months, objective response rate of 38.3%, and a disease control rate of 79.1% indicate potential clinical benefit. The absence of dose-limiting toxicities in the safety lead-in phase is a positive safety signal, despite the occurrence of adverse events and serious adverse events consistent with advanced cancer populations receiving combination therapies.
Source
The trial results were posted on 2026-06-23 on ClinicalTrials.gov, an official database of clinical studies. The full details are available on clinicaltrials.gov under the identifier NCT04740307.