Adaptimmune Therapeutics and Merck have agreed to begin a clinical trial next year assess the safety and efficacy of combining the anti-PD-1 inhibitor Keytruda (pembrolizumab) with Adaptimmune’s NY-ESO Spear T-cell therapy in multiple myeloma patients.
The agreement states that the trial will be sponsored by Adaptimmune, and includes a provision for a potential expansion to Phase 3 studies with multiple myeloma patients.
Although multiple myeloma (MM) has no cure, advances in therapy, such as autologous stem cell transplantation, radiation, and surgical care in certain cases, have helped to lessen the adverse effects of this disease and to manage associated complications. Patients are often treated with repeated rounds of combination therapy, with the time intervals to relapse becoming shorter with each successive round.
Adaptimmune’s Spear T-cell candidates have shown positive results in treating of multiple myeloma patients, and it may be a promising therapeutic approach when used in combination with other agents.
The Spear T-cell technology is designed to optimize T-cells’ ability to recognize specific cancer proteins, even if they are present in small amounts or located inside the cells. In an ongoing Phase 1/2a clinical trial (NCT01352286) evaluating the safety and efficacy of NY-ESO Spear T-cell therapy in multiple myeloma patients who underwent autologous stem cell transplant (ASCT), 91 percent of the patients (20 out of 22) showed response to treatment at 100 days after ASCT, according to a company press release.
Merck’s Keytruda, which is approved for melanoma and non-small cell lung cancer patients, is known to increase the immune system’s ability to recognize and fight tumor cells. Results from Phase 3 trials evaluating Keytruda in combination with standard therapy in myeloma patients have shown promising anti-tumor effects.
The researchers are assessing the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of combining Keytruda with NY-ESO Spear T-cell therapy in relapsed or refractory multiple myeloma patients. The study is planned to begin in the first half of 2017.
“In initial single-agent studies of our NY-ESO SPEAR T-cell therapy in patients with advanced myeloma in the context of stem cell transplantation, we have seen encouraging evidence of antitumor effect, safe administration and prolonged persistence of transduced cells,” said Rafael Amado, Adaptimmune’s chief medical officer. “Keytruda has shown preliminary evidence of activity in multiple myeloma, and there is preclinical evidence to support the view that the combination of NY-ESO SPEAR T-cell therapy and anti-PD1 therapy may lead to meaningful anti-tumor activity. We look forward to evaluating our therapy alone and in combination with Keytruda in a randomized trial of patients with multiple myeloma who are refractory or have relapsed with standard therapy.”
Multiple myeloma is the second most common hematological cancer, characterized by the abnormal expansion of plasma cells. According to estimates from the American Cancer Society, more than 30,000 people in the U.S. will be diagnosed with multiple myeloma diagnosis in 2016.