Published in the Journal of Clinical Oncology, results from the Phase II trial, MM-013 show that pomalidomide (Imnovid®) in combination with low-dose dexamethasone is effective in relapsed and refractory patients with renal impairment.
There were 3 cohorts in this trial; patients with moderate renal impairment (A), severe renal impairment (B) and severe impairment requiring haemodialysis (C). The results show that treatment with pomalidomide and dexamethasone led to an overall response rate of 39.4%, 32.4% and 14.3%, and disease control was achieved in 100%, 79.4% and 78.6%, for cohorts A, B and C respectively.
Furthermore, patients in cohort A achieved complete renal response (18.2%), and patients in cohort B achieved partial and minimal renal responses (5.9% and 29.4% respectively), however no patients in cohort C became haemodialysis independent. Finally, the safety profile of this treatment combination was determined to be acceptable in these patient cohorts.