New Combination Data of Secura Bio’s COPIKTRA® (duvelisib) Presented at the 2024 American Society of Hematology Meeting

Dr. Alison Moskowitz presented results of a Phase 1 study of combination duvelisib plus ruxolitinib in relapsed/refractory (R/R) peripheral T-cell lymphoma or cutaneous T-cell lymphoma

Results demonstrated an overall response rate (ORR) of 45%, complete response rate (CR) of 22%, and partial response (PR) rate of 22%

/EIN News/ -- SUMMERLIN, Nev., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, today announced Dr. Alison Moskowitz, Associate Attending at Memorial Sloan Kettering Cancer Center and lead investigator of the phase 1 study, presented new investigational combination data in an oral presentation at the 2024 American Society of Hematology (ASH) Meeting in San Diego, CA.

Data from the investigator-sponsored study were reported in an oral presentation entitled Dual-Targeted Therapy with Ruxolitinib Plus Duvelisib for T-cell Lymphoma. The study is a multi-center phase I trial of combination duvelisib plus ruxolitinib in patients with R/R peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL) or untreated T-prolymphocytic leukemia (T-PLL). The 2-part study was designed to 1) identify the maximum tolerated dose (MTD) and 2) to assess efficacy of the combination of duvelisib and ruxolitinib in two expansion cohorts in patients with lymphoma characterized by the presence (Cohort A) or absence (Cohort B) of genetic or immunohistochemical JAK/STAT pathway activation.

Dr Alison Moskowitz MD, said, “It was exciting to see compelling results in this late-stage patient population, particularly in the T-follicular helper (TFH) lymphoma population. Patients with relapsed/refractory PTCL or CTCL have few treatment options, and the results suggest further investigation in this population may be warranted.”  

The study enrolled a total of 49 patients (Part 1: n=8; Part II: n=41). The MTD was determined to be duvelisib 25 mg BID plus 20 mg ruxolitinib BID. Baseline histologies included 14 (29%) TFH lymphomas, 13 (27%) PTCL-not otherwise specified, 7 (14%) mycosis fungoides (MF), 5 (10%) T-PLL, 3 (6%) ALK-negative anaplastic large cell lymphoma (ALCL), 3 (6%) T-cell large granular lymphocytic leukemia (T-LGL), and 1 pt each with ALK-positive ALCL, adult T-cell lymphoma/leukemia, and monomorphic epitheliotropic intestinal T-cell lymphoma.

Results demonstrated an overall response rate (ORR) of 45%, a complete response (CR) rate of 22%, and a partial response (PR) rate of 22%. ORR and CR rates were 55% and 26% (Cohort A; n=31) compared with 21% and 14% (Cohort B; n=14). The highest activity observed was in TFH lymphomas (ORR 79%, CR 64%) and T-PLL (ORR 60%, CR 0%). The combination of duvelisib plus ruxolitinib was also shown to be particularly active in cases with evidence of JAK/STAT activation. Treatment-related grade (G) ≥3 adverse events included: neutropenia (24% G3, 14% G4), anemia (16% G3), thrombocytopenia (6% G3, 6% G4), lung infection (4% G3), hypertension (4% G3), hypertriglyceridemia (4% G3), transaminitis (4% G3), sepsis (2% G3, 2% G5), urinary tract infection (2% G3), diarrhea (2% G3), weight gain (2% G3), leukopenia (2% G3), and mucositis (2% G3). Further expansion for TFH lymphomas and T-PLL is planned.

Dr. David Sidransky, Clinical/Medical Advisor to the CEO at Secura Bio, Inc. added, “The data from this study are encouraging and show duvelisib to be a PI3K inhibitor with high clinical activity. We look forward to further development of duvelisib in these indications.”

About Peripheral T-cell Lymphoma
Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma that develops in mature white blood cells that circulate through the bloodstream and lymphatic system. PTCL accounts for between 10 and 15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. Although there are many different subtypes of PTCL, they often present in a similar way, with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin. There are currently no well-established standards of care for patients with relapsed or refractory disease.

About COPIKTRA (duvelisib)
COPIKTRA (duvelisib) is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first United States FDA approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant cells. PI3K signaling may lead to the proliferation of malignant cells and is thought to play a role in the formation and maintenance of a supportive tumor microenvironment.

INDICATIONS AND USAGE
COPIKTRA is a kinase inhibitor 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 lines of systemic therapy.

Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality.

COPIKTRA has been given Fast Track status in the United States for the treatment of adult patients with PTCL who have received at least one prior therapy. Additionally, COPIKTRA has received an Orphan Drug Designation in both the EU and the US for use in the treatment of T-cell lymphomas. Treatment of T-cell lymphoma is a disease category for which COPIKTRA is not currently indicated.

COPIKTRA is being investigated in combination with other agents across several types of solid and hematologic malignancies, through investigator-sponsored studies. Support for this study in the form of funding and duvelisib drug supply was provided by Secura Bio, Inc.

For more information on COPIKTRA, please visit https://copiktra.com/. Information about duvelisib clinical trials can be found on https://www.clinicaltrials.gov/.

IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA

WARNING: TREATMENT-RELATED MORTALITY AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See full prescribing information for complete boxed warning

• Treatment-related mortality occurred in 15% of COPIKTRA-treated patients
• Fatal and/or serious infections occurred in 31% of COPIKTRA-treated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected
• Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA
• Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA
• Fatal and/or serious pneumonitis occurred in 5% of COPIKTRA-treated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA
  

WARNINGS AND PRECAUTIONS

• Hepatotoxicity: Monitor hepatic function
• Neutropenia: Monitor blood counts
• Embryo-Fetal toxicity: COPIKTRA can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception
  

ADVERSE REACTIONS

• The most common adverse reactions (>20%) are diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia
  

DRUG INTERACTIONS

• CYP3A4 inhibitors: Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors
• Strong CYP3A4 inducers: Avoid coadministration
• Moderate CYP3A4 inducers: Avoid coadministration. If coadministration cannot be avoided, increase the dose of COPIKTRA
• CYP3A4 substrates: Monitor for signs of toxicities when coadministering COPIKTRA with sensitive CYP3A substrates

USE IN SPECIFIC POPULATIONS

• Lactation: Advise women not to breastfeed.
  

Please click here to see COPIKTRA Risk Evaluation and Mitigation Strategy (REMS)
Please click here to see full U.S. Prescribing Information, including Boxed WARNING, for COPIKTRA (duvelisib).
To report Adverse Reactions, contact FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch and Secura Bio at 1-800-9SECURA (1-844-973-2872).

About Secura Bio, Inc.
Secura Bio, Inc. is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of significant oncology therapies for physicians and their patients. For more information on Secura Bio, Inc., please visit https://www.securabio.com/.

Investor & Media Contact:

Will Brown
Chief Financial Officer
Phone: 619-986-1364
ir@securabio.com