New Data on Secura Bio's COPIKTRA® (duvelisib) at 2024 Hematology Meeting

Dr. Alison Moskowitz recently shared findings from a Phase 1 study evaluating the combination of duvelisib and ruxolitinib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL). This study, which took place at the 2024 American Society of Hematology (ASH) Meeting in San Diego, CA, presented promising results. Dr. Moskowitz, the lead investigator and an Associate Attending at Memorial Sloan Kettering Cancer Center, detailed the study outcomes in an oral presentation titled "Dual-Targeted Therapy with Ruxolitinib Plus Duvelisib for T-cell Lymphoma."

The study enrolled 49 patients and consisted of two parts: identifying the maximum tolerated dose (MTD) and assessing the efficacy of the duvelisib and ruxolitinib combination. The MTD was found to be duvelisib 25 mg taken twice daily along with 20 mg of ruxolitinib also taken twice daily. The trial was designed to evaluate the therapy in two expansion cohorts based on the presence (Cohort A) or absence (Cohort B) of genetic or immunohistochemical JAK/STAT pathway activation.

The results indicated an overall response rate (ORR) of 45%, with 22% of patients achieving complete responses (CR) and another 22% showing partial responses (PR). Patients in Cohort A, characterized by JAK/STAT pathway activation, had higher response rates with an ORR of 55% and a CR rate of 26%, compared to Cohort B which had an ORR of 21% and a CR rate of 14%. Notably, the highest activity was seen in T-follicular helper (TFH) lymphomas, with an ORR of 79% and a CR rate of 64%, and in T-prolymphocytic leukemia (T-PLL), with an ORR of 60%.

Dr. Moskowitz emphasized the significance of these findings, particularly for patients with limited treatment options. She noted the compelling results in the TFH lymphoma population and suggested that further investigation is warranted.

The study also reported treatment-related adverse events, including neutropenia (24% Grade 3, 14% Grade 4), anemia (16% Grade 3), and thrombocytopenia (6% Grade 3, 6% Grade 4). Other side effects included lung infections, hypertension, hypertriglyceridemia, transaminitis, sepsis, urinary tract infections, diarrhea, weight gain, leukopenia, and mucositis.

Dr. David Sidransky, Clinical/Medical Advisor to Secura Bio, Inc., praised the study's findings and highlighted the high clinical activity of duvelisib, a PI3K inhibitor. He expressed optimism for further development of duvelisib in treating these conditions.

Peripheral T-cell lymphoma (PTCL) is a rare and aggressive form of non-Hodgkin lymphoma affecting mature white blood cells. It accounts for 10-15% of all non-Hodgkin lymphomas, commonly impacting individuals aged 60 and older. PTCL typically presents with enlarged, painless lymph nodes in the neck, armpit, and groin. Currently, no well-established standards of care exist for patients with relapsed or refractory PTCL.

Duvelisib, marketed as COPIKTRA, is an oral inhibitor of phosphoinositide 3-kinase (PI3K) and is the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma. It is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies. Although not indicated for initial or second-line treatment of CLL or SLL, COPIKTRA has received Fast Track status for treating relapsed PTCL and Orphan Drug Designation in both the US and EU for T-cell lymphomas.

COPIKTRA is being explored in combination with other agents for various hematologic and solid malignancies in multiple investigator-sponsored studies. This study was supported by Secura Bio, Inc., which provided funding and duvelisib drug supply.