Study Demonstrates Drug Combination Is Well Tolerated, Safe and Effective for Patients with Aggressive Blood Cancer

Relapsed/refractory peripheral and cutaneous T-cell lymphomas (R/R PTCL and CTCL) are aggressive blood cancers that often resist standard therapy. Patients with these lymphomas may require stem cell transplants, but the disease needs to be brought under control before patients can undergo this treatment. A new study by investigators from PETAL Consortium at Mass General Brigham found the combination of duvelisib and romidepsin to be effective, tolerable and safe for patients with R/R PTCL and CTCL. Their findings suggest that this drug combination offers a novel strategy to help these patients control the disease in order to be eligible for stem cell transplants. The results are published in Blood Advances.

“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 (MGH), a founding member of the Mass General Brigham healthcare system. “Despite dose modifications and interruptions, high response rates were observed in patients.”

Clinicians administered the treatment to 38 patients, tracking treatment effectiveness, how long the patient lived and side effects. Study outcomes showed that the drug combination helped shrink or eliminate cancer in 61% of patients, with 47% having no detectable cancer. Eleven patients went on to receive stem cell transplants. Additionally, in patients with the nodal T-follicular helper cell subtype of lymphoma, 82% of patients responded well. The drug combination had manageable side effects, but one patient died from treatment-related complications.

“These findings support duvelisib and romidepsin’s efficacy, safety and tolerability, and we hope the study facilitates improved access to the treatment through insurance coverage and regulatory agency approvals,” said senior author Salvia Jain, MD, a founding member of the PETAL consortium and a hematologist and medical oncologist at MGH. “Future direction would lie in determining markers of response or resistance, ideally through non-invasive monitoring so the treatment can be personalized.”