Micrograph showing MM
MorphoSys AG has decided to stop developing MOR202 as a treatment for multiple myeloma (MM).
However, MorphoSys said it will complete the ongoing phase 1/2a trial of MOR202, and I-Mab Biopharma will continue developing MOR202 as an MM therapy for the Greater China region.
MOR202 is a human monoclonal HuCAL antibody directed against CD38, a validated target in MM.
MorphoSys is testing MOR202 in combination with other drugs in a phase 1/2a trial of patients with relapsed/refractory MM (NCT01421186).
The patients were assigned to receive MOR202 plus dexamethasone (Dex), MOR202 plus lenalidomide (Len) and Dex, or MOR202 plus pomalidomide (Pom) and Dex.
Results from this study were presented at the 2016 Annual Meeting of the German, Austrian and Swiss Societies for Hematology and Medical Oncology.
Data were reported for 38 patients—18 who had received MOR202 plus Dex, 7 who had received MOR202 plus Pom and Dex, and 13 who had received MOR202 plus Len and Dex.
The researchers said the maximum-tolerated dose of MOR202, alone or in combination, had not yet been reached. However, the data suggested MOR202 can be safely administered as a 2-hour intravenous infusion at doses up to 16 mg/kg.
The most frequent grade 3 or higher adverse events observed were hematologic in nature (leukopenia, lymphopenia, neutropenia, thrombocytopenia, and anemia).
One patient discontinued treatment due to an adverse event (decrease in platelet count) that may have been caused by MOR202 or Dex. One patient developed a transient anti-MOR202 antibody response.
There were no treatment-related deaths.
Efficacy data were available for 31 of the 38 patients. Fifteen patients responded (2 with complete responses). There were 7 responses in the Len/Dex arm, 5 in the Dex arm, and 3 in the Pom/Dex arm. Twelve responses were ongoing for up to 56 weeks.
MorphoSys said it expects to present final results from this study at an upcoming medical conference.
MorphoSys also said it will continue to support I-Mab Biopharma’s development of MOR202 in Greater China (China, Taiwan, Hong Kong, and Macao).
In November 2017, MorphoSys and I-Mab entered into an exclusive regional licensing agreement to develop and commercialize MOR202 in Greater China. I-Mab assumed exclusive responsibility for all subsequent development and commercialization of MOR202 in the agreed territory.