Phase 2 PRIMO sub-analysis highlights outcomes with duvelisib in patients with peripheral T-cell lymphoma who proceeded to stem cell transplant
Novel topical formulation of duvelisib in cutaneous T-cell lymphoma featured in Phase 1 Trials in Progress poster
BERKELEY HEIGHTS, N.J., Nov. 04, 2026 (GLOBE NEWSWIRE) — Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today announced two posters on duvelisib, the Company’s oral dual inhibitor of PI3K-δ and PI3K-γ, have been accepted for presentation at the upcoming 2026 American Society of Hematology (ASH) Annual Meeting taking place December 12-15, 2026, in New Orleans, Louisiana.
A poster characterizing outcomes for peripheral T-cell lymphoma (PTCL) patients from the completed Phase 2 PRIMO study who achieved sufficient disease control with duvelisib to subsequently undergo stem cell transplant will be presented. Final results from the PRIMO study were published earlier this year in the Journal of Clinical Oncology.
A “Trials in Progress” poster detailing a new Phase 1 study for a novel topical formulation of duvelisib also will be presented. This is the first-ever clinical study evaluating a topical PI3K-δ/γ inhibitor in patients with early-stage Mycosis fungoides (MF), the most common subtype of cutaneous T-cell lymphoma (CTCL).
Presentation Details
Poster Number: 1834
Title: Duvelisib in Patients with Relapsed/Refractory Peripheral T-cell Lymphoma: Final Results from the Phase 2 PRIMO Trial: Outcomes in Patients who Proceeded to Stem Cell Transplant
Session Date: Saturday, December 12, 2026
Time: 5:30 pm – 6:30 pm EST
Location: MCCNO – Hall F
Presenter: Neha Mehta-Shah, M.D., Washington University School of Medicine, St. Louis, MO
Poster Number: 3619
Title: A Phase 1 dose-escalation study of topical duvelisib in patients with early-stage mycosis fungoides (MF)
Session Date: Sunday, December 13, 2026
Time: 6:00 pm – 8:00 pm EST
Location: MCCNO – Hall F
Presenter: Sima Rozati, M.D., Ph.D., Johns Hopkins University School of Medicine, Baltimore, MD
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. ¹,²
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin lymphoma that develops when white blood cells become abnormal and accumulate on the skin, presenting as painful, scaly patches, plaques or tumors that can spread across the body. Mycosis fungoides (MF) is the most common form of CTCL, affecting approximately 50%-60% of CTCL patients. Current treatment is generally broad-acting and not aimed at underlying biological causes of the disease.
About COPIKTRA® (duvelisib)
COPIKTRA® is an oral inhibitor of phosphoinositide 3-kinase (PI3K) and the first US approved dual inhibitor of PI3K-delta and PI3K-gamma pathways, 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 indicated in the United States for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior lines of systemic therapy.³ COPIKTRA is also being developed for the treatment of peripheral T-cell lymphoma (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. It is also being developed for the treatment of cutaneous t-cell lymphoma (CTCL). Treatment of T-cell lymphomas is a disease category for which COPIKTRA is not currently indicated. For more information on COPIKTRA, please visit www.COPIKTRA.com.
INDICATIONS AND USAGE
COPIKTRA® (duvelisib) 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 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
- Treatment-related mortality occurred in 15% of COPIKTRA treated patients.
- 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
Treatment-related Mortality: In a randomized controlled trial in patients with relapsed or refractory CLL or SLL, treatment with COPIKTRA caused increased treatment-related mortality. With extended follow-up with a median of 63 months, treatment-related deaths occurred in 15% (23/158) of those patients in the overall population. In the indicated patient population, patients with relapsed or refractory CLL or SLL after at least two prior lines of systemic therapy. Treatment related deaths following treatment with COPIKTRA occurred in 14% (13/93) of patients. The most common cause of the treatment-related deaths were infections, which occurred in 9% and 11% of patients with relapsed or refractory CLL following at least one or two prior systemic therapies, respectively. COPIKTRA is not indicated and is not recommended for any patients in the initial or second-line treatment setting.
Infections: Serious, including fatal (18/442, 4%), infections occurred in 31% of patients receiving COPIKTRA. The most common serious infections were pneumonia, sepsis, and lower respiratory infections. Median time to onset of any grade infection was 3 months, with 75% of cases occurring within 6 months. Treat infections prior to initiation of COPIKTRA. Advise patients to report new or worsening signs and symptoms of infection. Cases of Pneumocystis jirovecii pneumonia (PJP) (1%) and cytomegalovirus (CMV) reactivation/infection (1%) occurred in patients taking COPIKTRA. Provide prophylaxis for PJP during treatment and following completion of treatment until the absolute CD4+ T cell count is greater than 200 cells/μL. Consider prophylactic antivirals during COPIKTRA treatment to prevent CMV infection, including CMV reactivation.
Diarrhea or Colitis: Serious, including fatal (1/442; 0.2%); diarrhea or colitis occurred in 18% of patients receiving COPIKTRA. Median time to onset of any grade diarrhea or colitis was 4 months, with 75% of cases occurring by 8 months. The median event duration was 0.5 months. Advise patients to report any new or worsening diarrhea.
Cutaneous Reactions: Serious, including fatal (2/442; 0.5%); cutaneous reactions occurred in 5% of patients receiving COPIKTRA. Fatal cases included drug reactions with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN). Median time to onset of any grade cutaneous reaction was 3 months with a median event duration of 1 month. Presenting features for serious events were primarily described as pruritic, erythematous, or maculo-papular. Less common presenting features include exanthem, desquamation, erythroderma, skin exfoliation, keratinocyte necrosis, and papular rash. Advise patients to report new or worsening cutaneous reactions.
Pneumonitis: Serious, including fatal (1/442; 0.2%), pneumonitis without an apparent infectious cause occurred in 5% of patients receiving COPIKTRA. Median time to onset of any grade pneumonitis was 4 months with 75% of cases occurring within 9 months. The median event duration was 1 month with 75% of cases resolving by 2 months.
Hepatotoxicity: Grade 3 and 4 ALT and/or AST elevation developed in 8% and 2%, respectively, of patients receiving COPIKTRA (N=442). Two percent of patients had both an ALT or AST > 3 X ULN and total bilirubin > 2 X ULN. Median time to onset of any grade transaminase elevation was 2 months with a median event duration of 1 month. Monitor hepatic function during treatment with COPIKTRA.
Neutropenia: Grade 3 or 4 neutropenia occurred in 42% of patients receiving COPIKTRA (N=442), with Grade 4 neutropenia occurring in 24% of all patients. Median time to onset of grade ≥3 neutropenia was 2 months. Monitor neutrophil counts at least every 2 weeks for the first 2 months of COPIKTRA therapy, and at least weekly in patients with neutrophil counts < 1.0 Gi/L (Grade 3-4).
Embryo-Fetal Toxicity: COPIKTRA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus and conduct pregnancy testing before initiating COPIKTRA treatment. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for 1 month after the last dose.
ADVERSE REACTIONS
B-cell Malignancies Summary
Fatal adverse reactions within 30 days of the last dose occurred in 8% (36/442) of patients treated with COPIKTRA 25 mg BID. Serious adverse reactions were reported in 289 patients (65%). The most frequent serious adverse reactions that occurred were infection (31%), diarrhea or colitis (18%), pneumonia (17%), rash (5%), and pneumonitis (5%). The most common adverse reactions (reported in ≥20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.
CLL/SLL
Fatal adverse reactions within 30 days of the last dose occurred in 12% (19/158) of patients treated with COPIKTRA and in 4% (7/155) of patients treated with ofatumumab. Serious adverse reactions were reported in 73% (115/158) of patients treated with COPIKTRA and most often involved infection (38%; 60/158) and diarrhea or colitis (23%; 36/158). The most common adverse reactions with COPIKTRA (reported in ≥20% of patients) were diarrhea or colitis, neutropenia, pyrexia, upper respiratory tract infection, pneumonia, rash, fatigue, nausea, anemia, and cough.
For specific information on the management of the adverse reactions above, please review Dose Modifications for Adverse Reactions within the full Prescribing Information.
DRUG INTERACTIONS
CYP3A4 Inducers: Coadministration with a strong or moderate CYP3A4 inducer may reduce COPIKTRA efficacy. Avoid coadministration with strong or moderate CYP3A4 inducers.
CYP3A4 Inhibitors: Coadministration with a strong CYP3A4 inhibitor may increase the risk of COPIKTRA toxicities. Reduce COPIKTRA dose when co-administered with a strong CYP3A4 inhibitor.
CYP3A4 Substrates: Coadministration of COPIKTRA with sensitive CYP3A4 substrates may increase the risk of toxicities of these drugs. Consider reducing the dose of the sensitive CYP3A4 substrate and monitoring signs of toxicities of the co-administered sensitive CYP3A4 substrate.
Please see the Prescribing Information, including Boxed Warning.
To report Adverse Reactions during use of COPIKTRA, contact Secura Bio, call 1-844-9Secura or 1-844-973-2872 and/or to FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
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/.
References
- Lymphoma Research Foundation. Understanding T-Cell Lymphomas: A Guide for Patients and Caregivers. Updated 2024. Available at: https://lymphoma.org/publication/tcell-lymphoma-guide/. Accessed April 17, 2026.
- Rangoonwala HI, Cascella M. Peripheral T-Cell Lymphoma. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. Available at: https://www.ncbi.nlm.nih.gov/books/NBK562301/. Accessed April 17, 2026.
- COPIKTRA [Package Insert]. Secura Bio, Inc. Berkeley Heights, NJ. 2021. Available at: COPIKTRA-PI-USCPR250042-1.pdf. Accessed April 17, 2026.
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