ClinicalTrials.gov posted results on 1 September 2026 for a completed Phase 2 study of pembrolizumab, also known as Keytruda, in relapsed or refractory classical Hodgkin lymphoma. The trial enrolled 203 participants and compared coformulated favezelimab/pembrolizumab with physician’s choice of bendamustine or gemcitabine. Median progression-free survival was 6.4 months with the coformulation versus 5.7 months with chemotherapy, while objective response was lower with the coformulation.
Background
The study evaluated coformulated favezelimab/pembrolizumab, also called MK-4280A, for classical Hodgkin lymphoma that had returned after treatment or had stopped responding to current treatment. Researchers sought to determine whether the coformulation could help participants live longer without the cancer worsening compared with chemotherapy. The listed interventions were favezelimab/pembrolizumab, bendamustine, and gemcitabine.
Trial design
This was a completed Phase 2 study identified as NCT05508867. It enrolled 203 participants with Hodgkin lymphoma. The comparator was physician’s choice of chemotherapy, specifically bendamustine or gemcitabine.
The registry reported progression-free survival assessed by investigators using Lugano response criteria, overall survival, objective response rate, duration of response, and adverse-event measures. No primary outcome entries were supplied in the data block.
Key results
For investigator-assessed progression-free survival, the median was 6.4 months with favezelimab/pembrolizumab and 5.7 months with physician’s choice chemotherapy. The supplied analysis reported a log-rank p-value of 0.0462 and a hazard ratio of 0.76, with a 95% confidence interval of 0.55 to 1.05.
Objective response rates favored chemotherapy: 44.2% of participants responded with favezelimab/pembrolizumab compared with 67.7% with physician’s choice chemotherapy. Among participants who responded, median duration of response was 11.0 months with the coformulation versus 5.4 months with chemotherapy.
Median overall survival was reported as NA in both groups. The registry counted at least one adverse event in 101 participants receiving favezelimab/pembrolizumab and 94 participants receiving chemotherapy. Treatment discontinuation because of an adverse event occurred in 15 participants in the coformulation group and 4 participants in the chemotherapy group.
What this means
The posted results showed a small numerical difference in median progression-free survival and a statistically reported log-rank analysis with a hazard ratio below 1, although the confidence interval extended from below to above 1. Chemotherapy produced the higher objective response rate, while responses lasted longer in the favezelimab/pembrolizumab group.
The safety counts show more participants discontinued treatment because of an adverse event with favezelimab/pembrolizumab than with physician’s choice chemotherapy. The supplied record did not include adverse-event types, severity, overall survival estimates, or confidence-interval values for the individual outcome measurements.
Source
Source: ClinicalTrials.gov, registry results for “A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma,” NCT05508867, posted 1 September 2026. The record is available at clinicaltrials.gov/study/NCT05508867.