Secura Bio Announces Poster Presentation Highlighting Extended Follow Up Analyses from Phase 2 PRIMO Trial at the 2025 American Society of Hematology Meeting
BERKELEY HEIGHTS, N. J., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today announced a poster presentation highlighting extended follow up analyses examining additional safety data and impact of prior lines of therapy from the Company’s Phase 2 PRIMO trial at the upcoming 2025 American Society of Hematology (ASH) Annual Meeting taking place on December 6-9, 2025 in Orlando, Florida. The PRIMO trial evaluated the investigational use of duvelisib as a single agent for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL).
The poster, entitled Duvelisib in patients with relapsed/refractory peripheral T-cell lymphoma: Final results from the phase 2 PRIMO trial - impact of prior therapy and expanded safety analysis, will be presented by Dr. Pier Luigi Zinzani, University of Bologna, on Sunday, December 7, 2025, from 6:00 PM to 8:00 PM (EST) in the Orange County Convention Center, West Halls B3-B4. The abstract is available here. Secura Bio, Inc. also presented results of the PRIMO trial at ASH in 2024.
The PRIMO clinical trial was a global, multicenter, open-label, single-arm trial sponsored by Secura Bio, Inc., that evaluated COPIKTRA for the treatment of adult patients with R/R PTCL. Based on the dose optimization phase results, an expansion group of 123 patients was added in which duvelisib was dosed at 75 mg twice daily for two cycles, followed by 25 mg twice daily.
Duvelisib will also be highlighted in other presentations, including:
- Dr. Hunter Cochran, Washington University School of Medicine, Washington University in St. Louis, will be presenting a poster entitled Favorable safety and efficacy in a phase II trial using duvelisib maintenance after autologous stem cell transplant in T-cell and B-cell non-Hodgkin lymphomas on Saturday, December 6, 2025, from 5:30 PM – 7:30 PM (EST) in the Orange County Convention Center, West Halls B3-B4
- Dr. Michael Slade, Washington University School of Medicine, Washington University in St. Louis, will be presenting an oral presentation entitled Primary analysis of Phase 1B trial of duvelisib for cytokine release syndrome prophylaxis in patients undergoing chimeric antigen receptor T-cell therapy for non-Hodgkin lymphoma on Monday, December 8, 2025, from 3:45 PM – 4:00 PM (EST) in the Orange County Convention Center, Sunburst Room (W340)
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 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 US 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.
IMPORTANT SAFETY INFORMATION ABOUT COPIKTRA
WARNING: FATAL AND SERIOUS TOXICITIES: INFECTIONS, DIARRHEA OR COLITIS, CUTANEOUS REACTIONS, and PNEUMONITIS
See full prescribing information for complete boxed warning
- Fatal and/or serious infections occurred in 31% (4% fatal) 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% (<1% fatal) of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.
- Fatal and/or serious cutaneous reactions occurred in 5% (<1% fatal) of COPIKTRA-treated patients. Withhold COPIKTRA.
- Fatal and/or serious pneumonitis occurred in 5% (<1% fatal) 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 patients 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
- CYP3A inducers: Avoid co-administration with strong or moderate CYP3A inducers.
- CYP3A inhibitors: Monitor for COPIKTRA toxicities when co-administered with strong or moderate CYP3A inhibitors. Reduce COPIKTRA dose to 15 mg twice daily when co-administered with strong CYP3A4 inhibitors.
- CYP3A substrates: Monitor for signs of toxicities when co-administering COPIKTRA with sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed.
About Secura Bio, Inc.
Secura Bio, Inc. is an integrated, commercial-stage pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies for physicians and their patients. For more information on Secura Bio, please visit https://www.securabio.com/.
Investor Contact
Will Brown
Chief Financial Officer
Phone: 619-986-1364
ir@securabio.com
Media Contact
Kit Rodophele
Ten Bridge Communications
Phone: 617-999-9620
krodophele@tenbridgecommunications.com
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