A phase I/IIa study of the human CD38 antibody MOR202 (MOR03087) in relapsed or refractory multiple myeloma

e80 reactions (IRRs), thrombocytopenia, anemia, neutropenia, lymphopenia, and infections. Results: Most analyzed efficacy endpoints (ie, ORR, TTP, TTR, OS, PFS, and MRP) were significantly correlated with daratumumab exposures. There was a maximum effect (Emax) relationship between daratumumab exposure and ORR. The drug concentration associated with maximal drug effect on ORR was identified. There was no apparent relationship between daratumumab exposure and IRR, thrombocytopenia, anemia, neutropenia, or lymphopenia. Although the overall event rate of infection appeared to increase numerically with drug exposure, this trend was not observed for grade 3 or higher infections. In general, a slightly lower incidence of grade 3 or higher AEs was observed in subjects with higher exposure than in subjects with lower exposure. Conclusion: Daratumumab exposure was strongly correlated with efficacy but not with the safety endpoints analyzed. This is consistent with the clinical data in which no dose-related safety signal was observed. The current daratumumab dose regimen (16mg/kg; weekly for 8 weeks, every 2 weeks for 16 weeks, and then every 4 weeks thereafter) provides a maximal effect on efficacy while remaining within an exposure range with no apparent relationship with AEs. Editorial support was provided by Janssen Global Services, LLC