MOR202 is an experimental treatment that is being developed by MorphoSys to treat refractory multiple myeloma in combination with Revlimid (lenalidomide) and dexamethasone. In China, the treatment is being developed as TJ202 by I-Mab Biopharma, which holds exclusive rights for the treatment in the greater China region.

What is multiple myeloma?

Myeloma is a cancer that affects certain types of immune cells, causing them to grow uncontrollably. Cancer cells produce large quantities of abnormal proteins that poison tissues and interfere with normal body processes.

All immune cells are made in the bone marrow. Myeloma cells can appear in the marrow of different bones and spread from bone to bone, which is why the disease is also called multiple myeloma. Refractory myeloma refers to myeloma that has failed to respond to multiple medications.

How does MOR202 work?

MOR202 is an artificial antibody with two recognition sites — one site recognizes a protein (CD38) found on the surface of myeloma cells while the other binds to a type of immune cell called natural killer T-cells. These immune cells are responsible for killing infected or damaged cells. By bringing the T-cells close to myeloma cells (because the antibody is bound to both cells), the treatment increases the ability of T-cells to kill myeloma cells, thereby treating the cancer.

Because MOR202 is an antibody, it must be infused into the bloodstream. The treatment takes about 30 minutes.

MOR202 in clinical trials

A Phase 1/2a clinical trial (NCT01421186) is evaluating the safety and preliminary efficacy of ascending doses of MOR202 in refractory myeloma patients at several sites in Germany and Austria. Patients receive MOR202 either alone or in combination with Revlimid and Pomalyst (pomalidomide).

The primary objectives of the trial are to determine safety, tolerability, and the recommended dose of MOR202 alone and in combination with the other treatments. Secondary outcome measures are the pharmacokinetics (movement in the body) and preliminary efficacy of MOR202 based on response rate (the number of patients who respond to the treatment), the duration of response, time-to-progression (the time that passes before cancer returns), and progression-free survival (the number of patients who survive and do not progress following treatment).

Interim data from the first 56 patients showed that responses were the best in the 17 patients treated with a combination of MOR202, Revlimid, and dexamethasone. This group had a 65% overall response rate, which included 12% of patients showing complete responses and 18% showing very good partial responses compared with the other two groups.

The study found no unexpected safety concerns, with the most frequent serious adverse events being low levels of immune cells.

These preliminary findings led I-Mab to design two additional clinical trials: a Phase 2 trial (NCT03860038) to assess MOR202 plus dexamethasone, and a Phase 3 trial (NCT03952091) to evaluate the efficacy of MOR202 plus Revlimid and dexamethasone.

The Phase 2 trial is currently recruiting an estimated 82 myeloma patients in Taiwan. All patients must have failed to respond to at least two prior lines of treatment, including a proteasome inhibitor and an immunomodulator. The primary endpoint of the study is to determine the overall response rate to the treatment. Secondary measures include the number of patients who achieve at least stable disease, the duration of the response, the time to disease progression or death, and overall survival. The trial is expected to be completed at the end of December 2021.

The Phase 3 trial is also recruiting myeloma patients who have failed to respond to at least one prior treatment, in 38 locations across China and Taiwan. The trial is expected to include 291 patients who will be randomly assigned to continue standard treatment (Revlimid plus dexamethasone) with or without the addition of MOR202. The primary endpoint of the study is to evaluate progression-free survival in either treatment group. The study is expected to conclude in July 2022.


Last updated: Dec. 2, 2019


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