Interim data from the first phase 3 study of a PI3K inhibitor to treat relapsed or refractory nodal T-follicular helper cell lymphoma (nTFHL) anticipated in early-2027
SUMMERLIN, Nev., June 09, 2025 (GLOBE NEWSWIRE) — Secura Bio, Inc. (www.securabio.com), an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today announced that the first patient has been dosed in its Phase 3 TERZO study of COPIKTRA (duvelisib) in adults with relapsed or refractory (R/R) nodal T-follicular helper cell lymphoma (nTFHL), a disease where there are currently no well-established standards of care for patients with relapsed or refractory disease.
“Patients with relapsed or refractory nodal T-follicular helper cell lymphoma need meaningful treatment options, with the potential to extend and improve the quality of their lives,” said Dr. Graham Collins, UK Site Investigator for the Terzo Study. “I am grateful to Secura Bio for continuing to evaluate COPIKTRA for diseases where the standard treatment protocol has been challenged by recurring relapses and mutations.”
The Phase 3 TERZO study is a multicenter, open-label, randomized controlled study of duvelisib versus investigator’s choice of gemcitabine or bendamustine in patients with R/R nTFHL. Patients in the European Union (CT: 2024-516605-23-00) and the United Kingdom (NCT06522737) will be randomized on a 1:1 basis and receive treatment until progressive disease (PD) or unacceptable toxicity. The primary endpoint of the study is progression-free survival. Secondary endpoints include overall survival, objective response rate, complete response rate, duration of response, number of participants with adverse events, and quality of life. The company expects to enroll approximately 124 patients with interim data from the study anticipated in early-2027.
“We are very pleased to have dosed our first patient in this Phase 3 study of COPIKTRA based on the results from our Phase 2 study in T-cell lymphomas – in particular the results from angioimmunoblastic T-cell lymphoma (AITL), a subtype of peripheral T-cell lymphoma (PTCL) that is strongly associated with the T follicular helper (TFH) cell phenotype,” said Chip Romp, President and CEO of Secura Bio. “We look forward to developing COPIKTRA beyond its initial indication in R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and continuing to build Secura Bio into a world-class biopharmaceutical company with a diverse portfolio of oncology assets.”
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. 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 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 therapies. 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. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.
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.
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 therapies.
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 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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Phone: 619-986-1364
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