Just about one month ago, pharmaceutical company Secura Bio, Inc. (“Secura”) shared that the company completed enrollment for the Phase 2 PRIMO clinical trial. Altogether, 101 patients enrolled. The trial seeks to evaluate COPIKTRA (duvelisib) for patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL).
So what is COPIKTRA? This orally administered phosphoinositide 3-kinase (PI3K) inhibitor impedes both PI3K-delta and PI3K-gamma. Altogether, COPIKTRA is the first FDA-approved therapy to inhibit these enzymes, which normally help malignant cell proliferation. Although it is being developed for use in patients with PTCL, it is not yet indicated for this use. Rather, COPIKTRA is indicated for patients with R/R chronic lymphocytic leukemia (CLL), follicular lymphoma, and small lymphocytic leukemia (SLL).
For PTCL, COPIKTRA was granted Fast Track and Orphan Drug designations for use as a mono therapy. However, researchers are also exploring a combination of COPIKTRA and FARYDAK (panobinostat).
Now, the Phase 2 PRIMO study will explore the impact of either 25mg or 75mg COPIKTRA in patients with PTCL. During the trial, patients will receive one of the above doses 2x daily until either the cancer progresses or the dose reaches a point of unacceptable toxicity. Later, an expansion group was added, with 75mg 2x daily for two dosing cycles, followed by 25mg 2x daily. Data from the trial should be available before the end of 2021.
Common side effects include:
- Neutropenia (low white blood cell count)
- Pneumonia and/or upper respiratory infections
- Anemia (low red blood cell count)
- Muscular and skeletal pain
However, in some patients, fatal or serious reactions did occur. These include fatal or serious skin reactions, pneumonitis, diarrhea, and infections.
Peripheral T-Cell Lymphoma (PTCL)
Peripheral T-cell lymphomas (PTCL) consist of a group of aggressive lymphomas in which natural killer (NK) cells and T-cells, which normally play a role in the immune system, become cancerous. Altogether, PTCL falls under the greater umbrella of non-Hodgkin’s lymphoma (NHL). Doctors are not exactly sure what causes PTCL to develop. However, the cancer forms in lymphoid tissue outside of the bone marrow and typically affects those aged 60 or older. Generally, PTCL affects males slightly more often than females. PTCL is more commonly found in Asia, the Caribbean, and Africa than within the United States.
Because there are multiple forms of PTCL, symptoms vary. However, some common symptoms include:
- Unintended weight loss
- Night sweats
- Enlarged lymph nodes, typically in the neck, groin, or armpits
- Note: Typically, the enlarged lymph nodes are not painful in any way. If not near the neck, groin, or armpits, the enlarged lymph node may be found near the ears or elbows.