Incyte has reported additional positive data from a Phase I/II clinical trial (ECHO-202) of its product candidate epacadostat in combination with Merck’s anti-PD-1 drug Keytruda (pembrolizumab) to treat advanced melanoma.
Epacadostat is a potent and selective oral inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1) enzyme’s activity on the tumour microenvironment.
In all efficacy-evaluable patients, the median progression-free survival (PFS) was found to be 12.4 months, with rates of 70% at six months, 54% at 12 months and 50% at 18 months.
While median PFS has not been achieved in treatment-naïve subjects, the PFS rates were observed to be 68%, 52% and 52% at six, 12 and 18 months, respectively.
Incyte chief medical officer Steven Stein said: “We are encouraged by the additional data from our ECHO-202 trial, which demonstrate robust and durable responses in patients with advanced melanoma treated with the combination of epacadostat and Keytruda.”
The two-part Phase I/II trial is designed to assess the safety and efficacy of the combination regimen.
In the dose escalation part, which has concluded patient enrolment, 25mg, 50mg and 100mg of epacadostat, will be administered in combination with 2mg/kg of IV Keytruda, while the second dose expansion part includes 50mg, 100mg and 300mg of epacadostat.
The trial is part of the ECHO clinical trial programme developed to investigate the efficacy and safety of epacadostat as a combination regimen for oncology.
ECHO includes ongoing Phase I and Phase II trials featuring a combination with PD-1 and PD-L1 inhibitors for various solid tumours and haematological malignancies, as well as a Phase III trial with a combination of Keytruda for unresectable or metastatic melanoma.