BERKELEY HEIGHTS, N.J. — Secura Bio, Inc., an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today announced the publication in the Journal of Clinical Oncology of the Phase 2 PRIMO data indicating that duvelisib, an oral dual inhibitor of PI3K-delta and PI3K-gamma, demonstrated significant clinical activity and tolerability in patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).
The PRIMO Phase 2 study was a global open-label, multi-center, single-arm trial investigating the safety and efficacy of duvelisib monotherapy in 123 adult R/R PTCL patients from the US, EU, UK, and Japan. The trial was conducted in two phases (dose optimization phase and dose expansion phase [PRIMO-EP]). The Journal of Clinical Oncology paper presents outcomes for 123 patients in the PRIMO-EP population. The trial demonstrated an overall response rate (ORR) of 48.0%, a complete response rate (CRR) of 33.3%, median progression-free survival (mPFS) of 3.4 months, and median overall survival (mOS) of 12.4 months. Currently available single agents have been observed to provide ORRs of less than 30% and CRRs below 15%.1-3
“PTCL is a rare, aggressive type of non-Hodgkin lymphoma, and relapsed and refractory PTCL is an area of tremendous unmet need. Currently, there are only limited treatments, and the treatments we have are effective for just a minority of patients and lack durability,” said one of the lead authors Neha Mehta-Shah, MD, MSCI, Associate Professor of Medicine at Washington University in St. Louis. “Duvelisib has demonstrated potential for this difficult-to-treat population, with rapid and clinically meaningful responses overall, including a substantial proportion of patients achieving complete remission and durable responses among patients with the angioimmunoblastic T-cell lymphoma form of the disease. At the same time, in this population, duvelisib’s safety profile was manageable with appropriate prophylaxis and monitoring.”
Duvelisib was dosed at 75 mg twice daily for two 28-day cycles, followed by 25 mg twice daily until progressive disease or unacceptable toxicity. Patients in the trial were heavily pretreated with a median (range) of two (1-9) prior anticancer therapies.
The safety profile observed in PRIMO was consistent with that seen in the previous duvelisib interim analyses of PRIMO, and adverse events were generally manageable with per-protocol dose modifications. The most frequently occurring treatment-emergent adverse events (TEAEs) occurring in ≥15% of patients were alanine aminotransferase increased (37.4%), aspartate aminotransferase increased (35.8%), neutrophil count decreased (33.3%), diarrhea (33.3%), platelet count decreased (26.0%), and fatigue (26.0%).
Deeper and more durable response in AITL subgroup
As reported in the Journal of Clinical Oncology, ORRs by baseline histology were highest in the AITL subgroup (62.2%), followed by the PTCL-NOS (49.1%) and ALCL (15.0%) subgroups. While not powered for subgroup comparisons, the AITL subgroup also differed meaningfully from the overall population as measured by CRR (51.4% vs. 33.3%), mPFS (8.3 vs. 3.4 months) and OS (18.1 vs. 12.4 months).
Based on these results, Secura Bio is conducting TERZO, a Phase 3 multicenter, open-label, randomized controlled clinical trial to evaluate duvelisib in R/R nodal T-follicular helper (TFH) cell lymphoma, in the European Union and the United Kingdom. The activity of duvelisib was particularly encouraging in the AITL subgroup of PRIMO (now classified as a subgroup of nodal TFH lymphoma). Click here for more information about the TERZO trial.
“The PRIMO data in AITL are especially promising because they provide a compelling biological rationale for duvelisib in TFH-derived lymphomas,” said Christiane Langer, MD, Senior Vice President, Head of Clinical and Medical Affairs at Secura Bio. “The TERZO trial is designed to confirm that rationale, and we are excited to have already surpassed the 50% enrollment mark. We are looking forward to its completion next year.”
Transplant subgroup outcomes
The Journal of Clinical Oncology paper also provides outcomes data on 19 patients who went on to receive stem cell transplant (SCT) at the time of treatment discontinuation (11 had a planned SCT, and 8 additional patients received unplanned SCT). Notably, the estimated 4-year overall survival in this cohort was 75%, supporting the potential role of duvelisib as an effective bridge to transplant in some patients with PTCL.
“We are encouraged by the fact that a significant number of patients went on to receive a transplant”, said Dr. Langer. “For some patients, duvelisib may allow reconsideration of stem cell transplant by achieving disease control quickly enough to make this a realistic next step in their treatment journey.”
Earlier PRIMO trial outcome data have supported duvelisib’s listing as a preferred treatment option for R/R PTCL within the National Comprehensive Cancer Network guidelines.4 In addition to Secura Bio’s Phase 3 TERZO trial, duvelisib is being studied in combination with CHOP as part of an intensive approach for patients with untreated PTCL in an ongoing US intergroup trial (A051902, NCT04803201).
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.5,6
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.7 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. 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
- O’Connor OA, Pro B, Pinter-Brown L, et al. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011;29(9):1182-1189.
- O’Connor OA, Horwitz S, Masszi T, et al. Belinostat in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study. J Clin Oncol. 2015;33(23):2492-2499.
- Coiffier B, Pro B, Prince HM, et al. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014; 7:11.
- National Comprehensive Cancer Network. T-cell Lymphomas (2.2026). Available at: https://www.nccn.org/professionals/physician_gls/pdf/t-cell.pdf. Accessed April 17, 2026.
- 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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