Merck & Co.’s marketed cancer therapy Keytruda® (pembrolizumab) will be studied with Affimed Therapeutics’ cancer immunotherapy candidate AFM13 in a Phase IB trial assessing the combination in patients with Hodgkin’s lymphoma. The value of the clinical research collaboration was not disclosed by Affimed, which announced the partnership today.
Affimed agreed to fund and conduct the Phase 1B trial, which is designed to establish a dosing regimen for the combination therapy as well as assess its safety and efficacy. Merck agreed to supply Affimed with Keytruda for the clinical trial, which the German biotech said was being planned to start in the first half of this year.
The combination therapy will be studied in patients with Hodgkin’s lymphoma whose disease has relapsed, or is refractory to chemotherapy—including treatment with the antibody-drug-conjugate AdcetrisTM (brentuximab vedotin), marketed by Seattle Genetics.
AFM13 is a bispecific antibody designed to treat CD30-positive malignancies that include Hodgkin’s lymphoma as well as T-cell lymphoma by targeting CD16A, an antigen expressed on natural killer (NK) cells. AFM13 is now in Phase II studies in Hodgkin’s lymphoma patients after showing an acceptable safety profile and preliminary antitumor activity in a Phase I study.
In patient-derived xenograft models, Affimed said, the combination of AFM13 and an anti-PD-1 antibody showed up to 90% of tumors eradicated. The preclinical studies, conducted at Stanford University, also showed that both NK and T cells infiltrated the tumors and that cytokine levels, including notably interferon-gamma, were elevated.
“Our development strategy is to combine our NK-cell engagers with other immunotherapies that could enhance their efficacy through the uptake of both NK cells and T cells, and the collaboration with Merck is an important step in executing this strategy,” Affimed CEO Adi Hoess, M.D., Ph.D., said in a statement.
Keytruda is a humanized monoclonal antibody that works by blocking interaction between the programmed death receptor-1 (PD-1) and its receptor ligands, PD-L1 and PD-L2, thus increasing the immune system’s ability to fight cancer in cells that produce the pigment responsible for color in the skin.
The FDA approved Keytruda in 2014 as the first PD-1 inhibitor indicated to treat unresectable or metastatic melanoma following treatment with ipilimumab. Keytruda is also indicated for patients who are BRAF V600 mutation positive, a BRAF inhibitor.