Secura Bio presented extended follow-up analyses from its Phase II PRIMO trial, evaluating the PI3K inhibitor Copiktra (duvelisib) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and aggressive cancer with a dire prognosis post-frontline failure.

The data presented at the annual American Society of Hematology (ASH), painted a picture of consistent efficacy and a manageable safety profile in a population historically starved for options. But beyond the numbers, the presentation signposted a strategic clinical development pathway.

To understand the significance of these findings and their implications for patients and the company’s future, Drug and Device World talked with Dr. Christiane Langer, Senior Vice President and Head of Clinical and Medical Affairs at Secura Bio. Dr. Langer unpacked the data, explained the rationale behind the company’s focused Phase III plans, and shared her vision for maximizing the impact of established oncology medicines.

A Landscape of High Unmet Need

Peripheral T-cell lymphoma represents a heterogenous group of rare non-Hodgkin lymphomas, notorious for their aggressive nature and poor outcomes. For patients whose disease relapses after or proves refractory to initial therapy, the treatment landscape is bleak. Historically, median overall survival in this relapsed/refractory (R/R) setting has been measured in mere months, often less than six.

“PTCL is a rare form of cancer/ lymphoma, with over two-thirds of patients experiencing relapsed or refractory disease and a very poor prognosis with a median overall survival of patients with relapsed/refractory PTCL historically less than six months,” Dr. Langer emphasized, setting the stage. “Unfortunately, that often translates to patients having to undergo multiple treatments over the course of their battle with PTCL.”

PRIMO Extended Data

The core of Secura Bio’s ASH presentation was updated data from the Phase II PRIMO study (NCT03372057), which investigated oral Copiktra monotherapy in patients with R/R PTCL. Copiktra is already approved by the US Food and Drug Administration (FDA) for certain patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), but its potential in T-cell malignancies is an active area of exploration.

The extended analyses reinforced Copiktra’s activity across a broad PTCL population. Crucially, this activity appeared consistent regardless of how many prior therapies a patient had endured. For clinicians, this is a critical differentiator in a late-line setting where patients are often heavily pretreated and increasingly frail.

“Copiktra’s impact in heavily pre-treated patients was critical for our team to understand, and, through our new analyses, we could demonstrate strong activity as well as a manageable safety profile in these patients regardless of how many prior lines of therapy they’d had previously,” Dr. Langer stated.

The data from Secura Bio showed durable responses and encouraging survival signals in this difficult-to-treat population. The consistency of the efficacy signal across subgroups defined by prior lines of therapy provides a compelling argument for Copiktra’s role as a viable option deep in the treatment sequence, potentially offering a lifeline where few exist.

Informing a Pivotal Phase III Strategy

Within the broader PTCL cohort, one subtype stood out: angioimmunoblastic T-cell lymphoma (AITL). In the PRIMO study, patients with AITL demonstrated particularly robust outcomes. “In the PRIMO study, the subgroup of patients with AITL demonstrated the highest response rates, progression-free survival, and overall survival of all subgroups,” noted Dr. Langer.

This strong signal did not go unnoticed. It directly informed Secura Bio’s decision to launch the Phase III TERZO trial (NCT06522737) earlier this year. However, the company’s strategic focus expanded from AITL specifically to the larger classification of nodal T-follicular helper cell lymphoma (nTFHL), which includes AITL along with other related subtypes.

“Finding the subgroup of patients who can benefit the most for any drug, certainly for an already approved drug, is critical work to enhance the value of the medicine and to change patients’ lives,” Dr. Langer explained. “In our ongoing Phase III TERZO trial, we are evaluating efficacy parameters such as response rates, duration of response, and progression-free survival as the primary endpoint. We will also be looking at overall survival, quality of life and of course safety as secondary measures.”

The rationale for focusing on nTFHL is twofold. First, it is grounded in the strong biological and clinical signal seen in AITL. Second, it addresses a clear gap in the market. “With little to no established standards of care for this patient group, the unmet need is also particularly high,” Dr. Langer added.

By targeting the nTFHL phenotype, Secura Bio is aligning its pivotal trial with lymphoma classification while pursuing a population with a critical need for new therapies. “Yes, we found that in the AITL patient group in the PRIMO trial, the efficacy signals were incredibly strong. With the emerging new classification of the nTFHL phenotype, AITL is only a portion of all nTHL patients, and therefore, it made sense to include the bigger patient population now making up the nTFHL subtype.”

Safety and Sustainability

A notable finding from the extended PRIMO analyses pertained to safety. The data suggested that longer treatment duration with Copiktra did not necessarily lead to a consistent pattern of higher rates of adverse events. This is a significant observation for a drug intended for chronic use in managing relapsed cancer.

“The strong safety profile of Copiktra as demonstrated in PRIMO, regardless of the number of treatment cycles with the drug, is important because it enables patients to receive the appropriate therapeutic dose and longer duration treatment to keep their disease at bay,” Dr. Langer commented.

This extended safety profile supports the potential for longer-term management of patients. It also opens the door to exploring Copiktra in combination with other agents, a common strategy in oncology to improve efficacy. A safety profile that remains manageable over time is a prerequisite for successful combination regimens, making this finding a positive indicator for Copiktra’s future development potential beyond monotherapy.

A Blueprint for Future Development

“The data really underscore the value of broadening the scope of patients for a given drug and maximizing impact for them,” Dr. Langer said, outlining the strategic vision. “Taking Copiktra as an example, as a company, we focused on exploring other indications to hopefully expand the number of people who can get real benefit from a drug already on the market. It’s a powerful approach that can complement de novo oncology innovation to ultimately save more lives.”

This approach leverages existing safety databases and manufacturing knowledge, potentially accelerating the path to patients for new indications. Dr. Langer sees the Copiktra experience as a template. “With this important data from our Phase II trial in PTCL, we are more confident than ever that the Secura Bio team can affect real change in how we look at different oncology medicines in the future, and, because of our strong biomarker-driven clinical development capabilities, have the Copiktra example to serve as a blueprint for future evaluation of other medicines to potentially add to our pipeline.”

The Road Ahead

For the hematology community and patients, Dr. Langer distilled the core message. “Copiktra is an FDA-approved medicine for people with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have received at least two prior therapies. The PRIMO Phase II data, and further extended analyses from this trial just presented at ASH, tell us that there are many more cancer patients out there who may potentially benefit from this drug. As a company, we believe we owe it to patients to make that happen.”

She summarized the clinical evidence: “We have now shown in the clinic positive outcomes in safety and efficacy from this treatment across a broad set of PTCL patient profiles and treatment experiences, and continue to evaluate other hematologic malignancies as well as different treatment combinations, dosing schedules, and administration modalities.”

The immediate next step is clear: the Phase III TERZO trial in nTFHL. When asked about upcoming milestones, Dr. Langer provided a timeline. “We look forward to enrolling our Phase III TERZO trial and potentially sharing interim data in 2027.”