Medivir AB has announces that the first patient has been enrolled in the company’s phase I/II study of birinapant in combination with the anti-PD-1 therapy Keytruda (pembrolizumab), which is marketed by MSD (known as Merck & Co., Inc, Kenilworth, NJ, USA in the US and Canada). The objectives of the study are to evaluate the safety, tolerability and preliminary efficacy of this combination in patients with treatment-resistant solid tumours.

The multicentre, single arm, open label study, which is primarily being run in the US, will be conducted in two parts. In the initial dose escalation (phase I) part of the study, the objective is to identify the recommended phase II dose of birinapant for use in combination with Keytruda. This is to be achieved by administering increasing doses of birinapant in combination with the approved dose of Keytruda to cohorts of up to 6 patients with refractory solid tumours.

Once the recommended phase II dose has been identified, the second part of the study will begin. The primary objective of the phase II part is to evaluate the safety and tolerability of birinapant in combination with Keytruda in several cohorts. Each cohort will be made up of patients with the same treatment refractory tumour type. An important secondary objective in the phase II part is the preliminary evaluation of the efficacy of the combination in each of the cohorts.

Under the terms of the agreement between Medivir and MSD (through a subsidiary), MSD will provide Keytruda for this study at no cost to Medivir. Medivir retains full rights to birinapant. Additional details were not disclosed.

“The approval of immune check-point inhibitors constituted a remarkable leap forward for many cancer patients, but there still remains a substantial opportunity to improve outcomes. Recent preclinical data have provided a strong scientific rationale for combining birinapant with immune checkpoint inhibitors such as Keytruda. We are therefore very pleased to enrol the first patient in this combination study, which will allow us to determine its safety and tolerability, as well as its potential efficacy, in patients with solid tumours who have no further treatment options,” said John Öhd, Chief Medical Officer at Medivir.