ONCOS-102 in PD-1 refractory advanced melanoma
PD-1 CPI refractory advanced melanoma is a major unmet medical need affecting up to 25,000 patients per year globally in the major markets. The diagnosis has poor prognosis and there are currently no approved treatment options available.
In the recently published phase 1 trial, ONCOS-102 demonstrated a highly competitive response rate (ORR) of 35% in this patient population in combination with a PD-1 CPI. Importantly, the strong ORR outcome was corroborated by shrinkage of non-injected lesions and biomarker data showing significant increase in T-cell infiltration and broad and persistent activation of immune-related gene signatures in responding patients.
Preparing for a phase 2 multi-cohort trial
Based on these promising early clinical results, Targovax is planning to conduct a larger, phase 2 multi-cohort study to further explore and validate the benefit of ONCOS-102 in PD-1 CPI refractory melanoma. This phase 2 study will be run in collaboration with Targovax’s partner Agenus, who will provide their class-leading Fc-enhanced CTLA-4 (botensilimab) and PD-1 (balstilimab) CPIs for combination with ONCOS-102. In the first part of the study, two groups will evaluate the safety and efficacy of (1) a higher dose of ONCOS-102 to be tested as a monotherapy and (2) the low and new higher dose of ONCOS-102 in combination with the PD-1 CPI balstilimab.
Following confirmation of the safety of the Increased ONCOS-102 dose, the study will proceed into its second part adding two more groups. In group (3) ONCOS-102 will for the first time be combined with a CTLA-4 CPI (botensilimab) and, ultimately, in (4) the triple combination of ONCOS-102, balstilimab and botensilimab will be tested.
The US Food and Drug Administration (FDA) has accepted the protocol and given the formal goahead to proceed with the trial.
ONCOS-102 is still in development in melanoma. We are not supplying the product outside trials such as expanded or compassionate uses basis until further data have been generated.
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Phase 1 study results published in Clinical Cancer Research
The phase 1 melanoma data were published in the prestigious scientific journal Clinical Cancer Research in October 2022: