Secura Bio Presents Extended Follow Up Analyses from Phase 2 PRIMO Trial in Patients with Relapsed/Refractory peripheral T-cell lymphoma at the 2025 American Society of Hematology Meeting
Longer-term analyses reinforce duvelisib’s activity across treatment-experienced PTCL populations, including patients with ≥3 prior lines of therapy, with no new safety signals emerging over time.
Findings further strengthen rationale for ongoing global Phase 3 TERZO study in nodal TFH lymphoma.
BERKELY HEIGHTS, N. J., Dec. 07, 2025 (GLOBE NEWSWIRE) — Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today presented extended follow up analyses examining additional safety data and impact of prior lines of therapy from the Company’s Phase 2 PRIMO trial (NCT03372057) at the 2025 American Society of Hematology (ASH) Annual Meeting. The results continue to show that duvelisib delivers meaningful clinical activity with a manageable safety profile, even in heavily pretreated patients, underscoring its potential role across a broad PTCL population.
The poster, titled “Duvelisib in patients with relapsed/refractory peripheral T-cell lymphoma: from the Phase 2 PRIMO trial – impact of prior therapy and expanded safety analysis”, was presented by Professor Pier Luigi Zinzani, Head of Hematology at the University of Bologna/Italy, and highlighted new analyses of the dose expansion phase of the PRIMO trial, which included a group of 123 patients who had received at least 2 cycles of one standard regimen. The PRIMO clinical trial was a global, multicenter, open-label, single-arm trial that evaluated the investigational use of duvelisib for the treatment of adult patients with R/R PTCL.
“PTCL patients often cycle through multiple treatments with little improvement in outcomes,” said Prof. Zinzani. “Seeing consistent efficacy even in those with ≥3 prior lines, and without emergent safety concerns at the recommended 75 mg lead-in dose, is highly encouraging. These results reinforce duvelisib’s therapeutic potential across this difficult-to-treat population.”
In the PRIMO expansion phase duvelisib was dosed at 75 mg twice daily for two cycles and followed by 25 mg twice daily, and the primary endpoint was Overall Response Rate (ORR).
New extended analyses demonstrated there was no consistent impact on efficacy outcomes for patients related to number of prior lines of treatment. In patients with 1, 2, and ≥3 prior lines of therapy, outcomes were as follows, respectively: ORR was 29%, 66%, 49%; complete response (CR) was 18%, 52%, 32%; median duration of response (DOR) was 6.5, 11.7, 7.9 months; median progression-free survival (mPFS) was 1.9, 9.0, 3.0 months, and median overall survival (OS) was 30.2, 22.7, 7.3 months. Interestingly, patients with more heavily pretreated disease demonstrated numerically favorable outcomes.
In the analyses, 68% percent of patients received prior CHOP-based therapy, 35% had salvage chemotherapy, 20% had autologous stem cell transplant, 17% had an HDAC inhibitor, and 38% had prior exposure to brentuximab vedotin.
Additionally, expanded safety analyses based on the number of dose cycles, where 123 patients received ≤2 cycles, 63 patients received >2 to 6 cycles, and 25 patients continued on to receive >6 cycles, revealed there was no consistent pattern of higher rates of persisting or emerging AEs with longer treatment duration. Rates of diarrhea showed a modest trend of increase, but there was no increase in rates of colitis.
Adverse events (AEs) in ≥20% of patients by treatment duration included: neutropenia, aminotransferase increase, diarrhea, thrombocytopenia, leukopenia, and fatigue. Grade ≥3 adverse events in ≥5% of patients included: neutropenia, aminotransferase increase, maculopapular rash, thrombocytopenia, lymphopenia, diarrhea, hypokalemia and hypoxia.
“These new analyses capture important insights on the many different profiles and treatment experiences of PTCL patients in our trial and demonstrate the efficacy and safety of duvelisib, regardless of baseline treatment characteristics and prior lines of treatment across the patient population,” said Dr. Christiane Langer, SVP, Head of Clinical and Medical Affairs at Secura Bio. “Secura Bio is committed to expanding the potential of this therapy and other existing oncology medicines to new cancer indications so that more patients have an opportunity to explore a medicine that may truly benefit them and extend their life.”
Previously, final data presented last year at ASH show outcomes including an ORR of 48% (59/123), with a CR rate of 33.3% (41/123). The mDOR was 7.9 months, the mPFS was 3.4 months with a mPFS by baseline histology of 8.3 months (AITL), 3.4 months (PTCL-NOS), and 1.6 months (ALCL), and the mOS was 12.4 months. The most common baseline histologies were PTCL-NOS, AITL, and ALCL. ORRs by baseline histology were 62.2% (AITL), 49.1% (PTCL-NOS), and 15.0% (ALCL). Efficacy in the AITL group was notably favorable, with AITL subgroup outcomes as follows: ORR (62%), CRR (51%), mDOR 11.7 months, mPFS 8.3 months, and mOS 18.1 months. The strength of these findings directly informed the ongoing Phase 3 TERZO trial (NCT06522737) in relapsed/refractory nodal T-follicular helper cell lymphoma (nTFHL), now actively enrolling at over 40 centers in Europe.
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 nodal T-Follicular Helper Cell Lymphoma
Nodal T-follicular helper cell lymphomas (nTFHL) comprise a group of aggressive non-Hodgkin lymphomas that share common genetic, clinical, and cell of origin features. This group of lymphomas originates from a type of white blood cell called a T-follicular helper cell. nTFHLs generally occur in people aged 60 and older and are slightly more common in males. nTFHLs most commonly present with widespread, enlarged, typically painless lymph nodes in the neck, armpit, and/or groin, in addition to rashes, B-symptoms, and immune dysregulation. 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/.
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