IO Biotech's experimental cancer vaccine Cylembio (imsapepimut/etimupepimut) fell just short of hitting its primary goal in a Phase III trial, despite extending progression-free survival (PFS) by more than eight months when combined with Merck & Co.'s Keytruda (pembrolizumab).
Cylembio is an off-the-shelf therapeutic cancer vaccine is designed to stimulate T cells against tumour cells and immune-suppressive cells expressing IDO1 and PD-L1.
The study, which enrolled 407 patients with unresectable or metastatic melanoma, found that the combination achieved a median PFS of 19.4 months compared to 11 months for Keytruda alone.
"The early and sustained separation of PFS curves demonstrated an improvement with a hazard ratio (HR) of 0.77," the company said in a release Monday, but the outcome "narrowly missed the study's statistical significance threshold of p≤0.045," coming in at p=0.056.
IO Biotech noted that PFS improvements were seen across most subgroups, including those having poor prognostic factors, with a "profound effect" in the cohort of 67 PD-L1-negative patients, who had a median PFS of 16.6 months versus 3 months for Keytruda monotherapy. A post-hoc analysis of the 371 patients without prior anti-PD-1 therapy also showed a benefit, with median PFS reaching 24.8 months and a HR of 0.74.
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