Posted: Thursday, December 15, 2022
During the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 565), Dan T. Vogl, MD, of Abramson Cancer Center, University of Pennsylvania, Perelman School of Medicine, Philadelphia, and colleagues presented their final efficacy and safety results with the immunocytokine modakafusp alfa in the treatment of patients with relapsed or refractory multiple myeloma. According to the investigators, this agent has a manageable safety profile and a novel mechanism of action.
A total of 100 patients with multiple myeloma who had received at least three prior lines of therapy and were refractory to immunomodulatory drugs and proteasome inhibitors were enrolled; 56 and 44 were assigned to dose-escalation and dose-expansion cohorts, respectively. Dose escalation (n = 56) was executed by administering modakafusp alfa at 10 dose levels between 0.001 and 6 mg/kg every week, 2, 3, or 4 weeks. The dose-expansion cohort (n = 44) received 0.4 mg/kg every 3 weeks or 1.5 mg/kg every 4 weeks with or without dexamethasone.
The maximum tolerated dose was determined as 3 mg/kg every 4 weeks. Of those receiving a dose of 0.4 mg/kg every 3 weeks, five had stable disease, and three experienced progressive disease; two patients given 0.4 mg/kg every 3 weeks plus dexamethasone had stable disease, and one patient had progressive disease. The objective response rate among patients given 1.5 mg/kg was 43%, with a median progression-free survival of 5.7 months. Of those treated with additional dexamethasone, one patient achieved a very good partial response, and one had stable disease.
Treatment-emergent adverse events of grade 3 or higher were observed in 88% and 87% of those treated with and without dexamethasone, respectively. Measurable residual disease (MRD) samples were collected from four individuals treated with 1.5 mg/kg of modakafusp alfa at screening and who had a suspected complete response; one patient achieved MRD negativity.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.