A real-world study by investigators from the PETAL Consortium at Mass General Brigham has demonstrated that the combination of duvelisib and romidepsin offers an effective treatment option for patients with relapsed/refractory peripheral and cutaneous T-cell lymphomas (R/R PTCL and CTCL). The research, published in Blood Advances, provides compelling evidence for this drug combination as a bridge to potentially curative stem cell transplantation.
Study Design and Patient Population
The study tracked 38 patients with R/R PTCL and CTCL who received the duvelisib-romidepsin combination therapy. Clinicians monitored treatment effectiveness, overall survival, and adverse events across diverse clinical settings. The research builds upon prior clinical trials by providing a comprehensive view of the drug combination's performance in real-world clinical practice.
"This real-world study builds upon prior clinical trials by providing a more comprehensive view of using the drug combination in clinical practice, including variations in clinical setting, prescribing patterns, and adverse event management within a diverse, higher-risk population," said first author Josie Ford, BS, a clinical research coordinator at Massachusetts General Hospital.
Clinical Outcomes and Response Rates
The study demonstrated significant clinical activity with the drug combination achieving a 61% overall response rate. Notably, 47% of patients achieved complete response with no detectable cancer remaining. The treatment's effectiveness was particularly pronounced in patients with the nodal T-follicular helper cell subtype of lymphoma, where 82% of patients responded well to the combination therapy.
Bridge to Transplantation
A critical finding of the study was that 11 patients successfully proceeded to receive stem cell transplants following treatment with the duvelisib-romidepsin combination. This outcome is particularly significant given that R/R PTCL and CTCL are aggressive blood cancers that often resist standard therapy, and patients typically require disease control before becoming eligible for potentially curative stem cell transplantation.
Safety Profile and Management
The drug combination demonstrated manageable side effects, though dose modifications and treatment interruptions were necessary in some patients. Despite these adjustments, high response rates were maintained throughout the study period. However, the research documented one treatment-related death, highlighting the importance of careful patient monitoring and adverse event management.
"Despite dose modifications and interruptions, high response rates were observed in patients," Ford noted, emphasizing the treatment's maintained efficacy even with necessary safety adjustments.
Clinical Implications
The findings suggest that the duvelisib-romidepsin combination offers a novel therapeutic strategy for patients with these challenging lymphomas. The ability to achieve disease control sufficient for stem cell transplant eligibility represents a significant advancement for patients with limited treatment options in the relapsed/refractory setting.
