FDA approves novel immunotherapy for cutaneous T-cell lymphoma
Click Here to Manage Email Alerts
The FDA approved the novel immunotherapy denileukin diftitox-cxdl for treatment of certain patients with relapsed or refractory cutaneous T-cell lymphoma.
The indication applies to use of the agent by patients with stage I to stage III disease who received at least one prior systemic therapy.
Denileukin diftitox-cxdl (Lymphir, Citius Pharma) is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin fragments, according to its manufacturer.
It binds to IL-2 receptors on the surface of cells. The diphtheria toxin fragments enter the cells and inhibit protein synthesis, according to the company.
The FDA based approval on results of the phase 3 Study 302.
The multicenter, single-arm trial’s efficacy population included 69 patients (median age, 64 years; range, 28-87; 65% men; 73% white; 19% Black or African American) with relapsed or refractory cutaneous T-cell lymphoma.
All patients had stage I (30%), stage II (48%) or stage III disease (22%), and they had CD25 expression on at least 20% of biopsied malignant cells per immunohistochemistry. Patients had received a median four prior therapies (range, 1-18).
Study participants received 9 µg/kg denileukin diftitox-cxdl via IV daily on days 1 through 5 of each 21-day cycle. Treatment continued until disease progression or unacceptable toxicity.
Objective response rate per independent review committee assessment served as the primary endpoint.
Researchers reported an ORR of 36.2% (95% CI, 25-48.7), with 8.7% of patients achieving complete response.
Half (52%) of responses lasted at least 6 months, and 20% lasted at least 12 months. Eight patients (12.5%) had complete clearing of skin disease.
Researchers reported 31.7% of patients demonstrated clinically significant improvement in pruritus, assessed as an exploratory endpoint.
Denileukin diftitox-cxdl exhibited a safety profile consistent with prior reports. Safety analyses from three studies that included a combined 119 patients with cutaneous T-cell lymphoma who received 9 µg/kg doses showed the most common adverse events included increased transaminases, decreased albumin, nausea, decreased hemoglobin, edema, fatigue, musculoskeletal pain, chills, constipation, rash, pyrexia and capillary leak syndrome.
"I have seen the profound negative effect on the quality of life in patients with [relapsed or refractory cutaneous T-cell lymphoma],” Francine Foss, MD, professor of hematology and director of the multidisciplinary T-cell lymphoma program at Yale Cancer Center, said in a Citius Pharma press release. “Given the long-term nature of the disease, pruritus, ulceration of the tumors and secondary pyogenic skin infection, it is vital to get this skin involvement under control. Lymphir is the first therapeutic option in many years to offer hope of reducing skin disease, bringing us one step closer to filling the need for [patients with cutaneous T-cell lymphoma], particularly those that are not able to complete or continue prior therapies.”
Click Here to Manage Email Alerts