SUMMERLIN, Nev., Nov. 06, 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 a poster presentation highlighting new data on the investigational use of COPIKTRA® (duvelisib) both as a single agent and in combination therapy for the treatment of Peripheral T-cell Lymphoma (PTCL) and advanced hematologic malignancies at the upcoming 2024 American Society of Hematology (ASH) Annual Meeting taking place on December 7-10, 2024 in San Diego, CA.
The poster, entitled: Duvelisib in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma: Final Results from the Phase 2 PRIMO Trial highlights the outcomes of 123 patients in the PRIMO dose expansion phase of the PRIMO clinical trial and will be presented by Dr. Neha Mehta-Shah, Washington University School of Medicine, on Sunday, December 8, 2024, from 6:00 PM to 8:00 PM (PST) in the San Diego Convention Center, Halls G-H. The abstract is now available here.
The PRIMO clinical trial was a global, multicenter, open-label, parallel cohort, Phase 2 study sponsored by Secura Bio, Inc., that evaluated COPIKTRA for the treatment of adult patients with relapsed or refractory (R/R) Peripheral T-cell Lymphoma (PTCL). Based on the dose optimization phase results, an expansion group of 123 patients was added in which COPIKTRA was dosed at 75 mg twice daily for two cycles, followed by 25 mg twice daily.
COPIKTRA will also be highlighted in a number of other poster presentations evaluating combination therapy, including:
- Dr Alison Moskowitz, Memorial Sloan Kettering Cancer Center, will be presenting an oral presentation entitled Dual-targeted therapy with ruxolitinib plus duvelisib for T-cell lymphoma. Dr Moskowitz will be presenting on Sunday, December 8, 2024, from 9:30 AM - 11:00 AM (PST) in the San Diego Convention Center, Ballroom 20CD
- Dr Jennifer Crombie, Dana-Farber Cancer Institute, will be presenting a poster entitled A Phase 2 Study of Duvelisib and Venetoclax in Patients with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) or Richter’s Syndrome (RS) on Monday, December 9, 2024, from 6:00 PM - 8:00 PM (PST) in the San Diego Convention Center, Halls G-H
- Dr Hayder Saeed, Moffitt Cancer Center, will be presenting a poster entitled A Phase I Study Of Duvelisib In Combination With Oral Azacitidine (BMS-986345) In Lymphoid Malignancy on Sunday, December 8, 2024, from 6:00 PM - 8:00 PM (PST) in the San Diego Convention Center, Halls G-H
- Dr Josie Ford, Massachusetts General Hospital, will be presenting a poster entitled Real-World Evidence for Duvelisib and Romidepsin Combination in Patients with Relapsed/Refractory Peripheral T-Cell Lymphomas on Monday, December 9, 2024, from 6:00 PM - 8:00 PM (PST) in the San Diego Convention Center, Halls G-H
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 10-15% of all non-Hodgkin lymphomas and generally affects people aged 60 years and older. Although there are many different subtypes of peripheral T-cell lymphoma, 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 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. 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 is also being investigated for the treatment of lymphomas, including peripheral T-cell lymphomas (PTCL). 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 for use in the treatment of T-cell lymphomas. Treatment of T-cell lymphomas 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. 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
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.
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 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 is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of significant oncology therapies for physicians and their patients. Its product, COPIKTRA, is currently approved for the treatment of multiple B-cell malignancies and is also being investigated for the treatment of PTCL, for which it has received Fast Track status in the United States and is being investigated in combination with other agents through investigator-sponsored studies. For more information on Secura Bio, please visit https://www.securabio.com/.
Investor & Media Contact
Will Brown
Chief Financial Officer
Phone: 334-313-2319
ir@securabio.com
