Secura Bio has randomized 35 of 124 planned patients and activated 43 of 45 sites across ten European countries in its Phase 3 TERZO trial of duvelisib in relapsed or refractory nodal T-follicular helper cell lymphoma, keeping the study on pace for an interim readout in early 2027. Separately, the company reported more than 30% year-over-year U.S. net sales growth for COPIKTRA through November and noted duvelisib’s addition to the NCCN Clinical Practice Guidelines in Cutaneous Lymphoma for mycosis fungoides/Sézary syndrome.
The core update centers on operational execution of TERZO, a multicenter, open-label, randomized study comparing duvelisib against investigator’s choice of gemcitabine or bendamustine in adults with relapsed/refractory nTFHL. Patients in the EU and UK are randomized 1:1 and treated until progression or unacceptable toxicity. The primary endpoint is progression-free survival, with overall survival, response metrics, adverse events, and quality of life as secondary endpoints. First patient dosing began in June, and the company expects to complete enrollment at approximately 124 patients, a typical scale for this rare PTCL subset.
Strategically, Secura is pursuing two parallel tracks: a label-expansion push for duvelisib into TFH-phenotype T-cell lymphomas via TERZO, and a near-term commercial lift through guideline inclusion and geographic access expansion. Concentrating trial enrollment in Europe and the UK is notable given the U.S. headwinds facing the PI3K class, where regulators have pressed for randomized evidence with survival follow-up after historical safety concerns. Anchoring PFS as the primary endpoint with OS as a key secondary threads that needle and may align more readily with EMA expectations, while leaving room to calibrate a U.S. path once survival data mature. The headquarters move to New Jersey and added clinical leadership suggest a build-out to support both clinical oversight and business development as the company evaluates additional commercial-stage hematology-oncology assets.
For sites, TERZO’s design keeps operational friction low — no biomarker gating, standard comparator options, and a familiar safety profile requiring tight monitoring — but rarity of nTFHL means patient identification and referral networks will determine accrual velocity. CROs and vendors will need to lean into risk mitigation for class-specific toxicities and robust DSMB oversight, particularly as regulators scrutinize any OS signals relative to control. Sponsors running in adjacent PTCL segments should note the multi-country approach as a practical template for small-population accrual and the use of investigator’s choice comparators to reduce screen failures and align with real-world practice.
The commercial updates matter beyond near-term revenue. NCCN listing in cutaneous lymphoma, while not an approval, can support compendia-based coverage and increase off-label utilization in MF/SS, potentially smoothing volatility as the TERZO readout approaches. Territory expansion to Puerto Rico, the EU, the UK, and Israel positions distribution infrastructure ahead of any future label movement but also diversifies demand sources if U.S. growth plateaus.
Looking ahead, the key watch items are accrual slope through 2026, the interim analysis boundary and data scope in early 2027, and whether Secura introduces U.S. sites or protocol amendments to address evolving regulatory expectations for PI3K inhibitors. The central risk remains class-driven: even with a PFS win, any imbalance in survival or serious adverse events could cloud regulatory negotiations. On the flip side, a clean safety profile with clinically meaningful durability in this high-need population would strengthen the case for a differentiated role in T-cell lymphomas. Parallel business development moves will signal how aggressively Secura intends to hedge its portfolio against category risk while it waits for TERZO to read out.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
