Posted: Monday, June 19, 2023
Maintenance therapy with the proteasome inhibitor carfilzomib and the immunomodulatory agent pomalidomide in combination with dexamethasone (KPd) appeared to deepen responses in patients with high-risk myeloma, according to Ajay K. Nooka, MD, MPH, of Emory University, Atlanta, and colleagues. Despite the “encouraging” results of this phase II trial and safety run-in cohort analysis, which were presented during the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract 8001) and simultaneously published in the Journal of Clinical Oncology, further development of remission-sustaining strategies may be necessary.
Newly diagnosed patients who achieved a partial response or better after undergoing autologous stem cell transplantation were administered KPd in 28-day cycles. After a safety run-in analysis of the first 3 patients, an additional 26 were enrolled.
Complete and very good partial responses or better deepened from an initial 24.1% and 68.9%, respectively, to 79.3% and 100%. The median duration of the time to best response was 2.1 months. Of the 15 patients evaluable for measurable residual disease (MRD), 80.0% and 53.3% achieved MRD negativity at a threshold of 10-5 and 10-6 cells, respectively. After a median follow-up of 25.8 months, the 36-month progression-free survival rate was 63.2%, and the 36-month overall survival rate was 72.4%. Although progression-free survival outcomes did not appear to differ across racial groups, the 36-month overall survival rate was found to be significantly lower in Black versus White patients (61.1% vs. 85.7%).
At data cutoff, 37.9% of patients remained on treatment; permanent treatment discontinuation was most frequently attributed to progressive disease (27.6%). Among the six patients who died, the most common cause was progressive disease (83.3%). Fever (37.9%), fatigue (34.5%), diarrhea (27.6%), nausea (24.1%), cough (20.7%), muscle cramps (20.1%), and acneiform rash (20.1%) were the most frequently reported treatment-emergent adverse events. Treatment-emergent adverse events of interest included cardiac events (10.3%), cataracts (17.2%), neutropenia (6.9%), and anemia (10.3%).
Disclosure: For full disclosures of the study authors, visit coi.asco.org.