© 2025 MJH Life Sciences™ and CURE - Oncology & Cancer News for Patients & Caregivers. All rights reserved.
Spencer, Assistant Editor of CURE®, has been with MJH Life Sciences since 2024. A graduate of Rowan University with a bachelor's degree in health communication, Spencer enjoys spending time with family and friends, hiking, playing guitar and rock climbing.
The first patient has been dosed in the phase 3 TERZO trial of Copiktra for relapsed or refractory nodal T-follicular helper cell lymphoma.
The first patient has been dosed in the phase 3 TERZO study evaluating Copiktra (duvelisib) in patients with relapsed or refractory nodal T-follicular helper cell lymphoma, according to a news release from Secura Bio, Inc.
Of note, nodal T-follicular helper cell lymphoma currently does not have a well-established standard of care for patients with relapsed or refractory disease.
This study is recruiting participants at The Christie NHS Foundation Trust, located in Manchester, United Kingdom. For more information, contact Dr. Timothy Illidge at +44-161-446-3332 or by email at tim.illidge@manchester.ac.uk. Additionally, you can use the trial identifier NCT06522737 to read more on clinicaltrials.gov.
“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,” Dr. Graham Collins, UK Site Investigator for the TERZO study, said in the news release. “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.”
Progression-free survival: time patients live without cancer worsening during and after treatment.
Overall survival: time from treatment start until death from any cause.
Response rate: percentage of patients whose cancer shrinks or disappears after treatment.
Duration of response: length of time a treatment controls cancer after it initially responds.
Quality of life: patient’s overall well-being during and after treatment.
The phase 3 trial will compare Copiktra with investigator’s choice of Gemzar (gemcitabine) or Bendeka (bendamustine) in patients with relapsed or refractory non–transformed follicular lymphoma. This multicenter, open-label study is randomly enrolling patients across the European Union and United Kingdom. Treatment will continue until disease progression or unacceptable side effects. The main focus of the trial is to improve progression-free survival, while additional measures include overall survival, response rates, duration of response, side effects and quality of life. Interim results are expected in early 2027, with approximatley 124 patients planned for enrollment.
“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, a subtype of peripheral T-cell lymphoma that is strongly associated with the T follicular helper cell phenotype,” Chip Romp, president and CEO of Secura Bio, said in the news release. “We look forward to developing Copiktra beyond its initial indication in relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and continuing to build Secura Bio into a world-class biopharmaceutical company with a diverse portfolio of oncology assets.”
Patients with relapsed or refractory nodal T-follicular helper cell lymphoma need meaningful treatment options.
Serious infections occurred in 31% of patients receiving Copiktra, with 4% fatal. Treatment should be paused if infection is suspected. Serious or fatal diarrhea or colitis occurred in 18% of patients, serious or fatal skin reactions in 5%, and serious or fatal pneumonitis in 5%. Copiktra should be withheld if these side effects develop.
Nodal T-follicular helper cell lymphomas are a rare, aggressive form of non-Hodgkin lymphoma that begins in T-follicular helper cells, a specialized type of white blood cell. This disease usually develops in adults older than 60 and occurs more often in men. Patients commonly present with swollen, painless lymph nodes in areas like the neck, armpits or groin. For those whose disease returns or does not respond to treatment, no standard approach to care has been established.
Copiktra, an oral inhibitor of phosphoinositide 3-kinase (PI3K), targets both the PI3K-delta and PI3K-gamma pathways — key drivers of cancer cell growth and survival. The drug is approved in the United States for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have already received at least two treatments. Although not currently approved for T-cell lymphomas, Copiktra is being studied for peripheral T-cell lymphoma, including in trials sponsored by independent investigators.
For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.
Related Content:
