Array BioPharma and Merck agreed to carry out a clinical trial combining Array’s oral MEK inhibitor binimetinib with Merck’s anti-programmed cell death protein 1 (anti-PD-1) therapy Keytruda® (pembrolizumab) in patients with metastatic colorectal cancer (CRC) with microsatellite stable tumors (MSS CRC). The proposed Merck-sponsored trial, which is projected to start during the second half of 2017, will be designed to establish dosing for the combination therapy, as well as explore the potential antitumor activity of a number of treatment regimens. No financial details were disclosed.
“Array is excited to announce this partnership with Merck, an established leader in the field of immuno-oncology,” said Ron Squarer, CEO, Array BioPharma. “Given the synergistic activity we have seen with our MEK inhibitor when combined with anti-PD-1 therapy in preclinical models, and based on emerging clinical data, we are optimistic that this combination holds great potential for cancer patients.”
Array and Merck have announced the partnership a couple of days after the EC approved Keytruda for treating relapsed or refractory classical Hodgkin's lymphoma in patients who have failed autologous stem cell transplantation and brentuximab vedotin (BV) or who are not eligible for transplant and have failed BV therapy.
The EC’s approval of Keytruda for the Hodgkin's lymphoma indication, announced late Friday, was based on data from 241 patients in the KEYNOTE-087 and KEYNOTE-013 studies. Data from the studies showed that Keytruda therapy resulted in overall response rates of 69% and 58%, respectively, complete remission rates (CRR) of 22% and 19%, respectively, and partial remission rates of 47% and 39%, respectively. Commenting on the approval on Friday, Roger Dansey, M.D., svp and therapeutic area head, oncology late-stage development at Merck Research Laboratories, stated, “Today’s approval brings an important new treatment option to patients in Europe with classical Hodgkin's lymphoma who have not responded to existing therapies. This milestone underscores our commitment to evaluating Keytruda in diseases with unmet need facing the hematology community.”
In March, Array withdrew a previously filed NDA for binimetinib as monotherapy in the treatment of NRAS-mutant melanoma.The firm said feedback from FDA indicated that there wasn’t enough clinical data to demonstrate efficacy of binimetinib monotherapy, but that ongoing clinical trials would continue.
