Immutep Limited’s combination of eftilagimod alpha with pembrolizumab (KEYTRUDA) is safe and well tolerated at doses up to 30 mg per subcutaneous injection, Immutep on Friday reported Database Safety Monitoring Board’s (DSMB) confirmation.
In this first-in-man TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial in Australia, efti is combined with pembrolizumab in unresectable or metastatic melanoma patients. The data to date shows no safety concerns from the combination with doses of efti at 1 mg, 6 mg, and 30 mg. No drug related serious adverse events have been reported and the DSMB concluded repeated injections of efti are safe and well tolerated.
Dr. Frédéric Triebel, Immutep’s Chief Scientific and Medical Officer, said: “There is limited clinical experience with combining an APC activator such as efti with an immune checkpoint inhibitor such as pembrolizumab, analogous to pushing the accelerator and also releasing the brakes on cancer-fighting T cells. Therefore, the TACTI-mel trial design included certain key safety measures such as starting with a low dose and at cycle five, which excludes patients with early severe adverse events to pembrolizumab, and limiting treatment to six months. The positive results now provide the basis to safely extend the clinical trial to start at cycle one with the recommended Phase II dose and for a 12-month duration, meaning patients could benefit earlier and for longer from the combination.”