CRANFORD, N.J. – November 05, 2026 -- Citius Oncology (Nasdaq: CTOR) reported that 13 of 41 heavily pretreated cutaneous T-cell lymphoma (CTCL) patients with significant itch (32%; 95% CI, 18.1–48.1) achieved a clinically meaningful itch reduction on LYMPHIR (denileukin diftitox-cxdl) in the pivotal Study 302. The health-related quality of life (HRQoL) data were presented orally by Christiane Querfeld, MD, PhD, of City of Hope at the EORTC-CLTG 2026 Annual Meeting in Berlin, held October 8–10, 2026.
Responders show Skindex-29 improvement of up to 13.69 points
Among 25 responders in the primary analysis set (Stage I–III, n=69), the mean change from baseline in Skindex-29 Total Score ranged from −5.38 to −13.69 points across assessments. Lower scores indicate better quality of life. Non-responders showed slightly positive to near-zero changes.
In the full analysis set (Stage I–IV, n=81), responders sustained improvements over non-responders across all three Skindex-29 domains: symptoms, emotions and functioning.
FACT-G score rises 3.21 points for responders and falls 2.28 for non-responders
On the general Functional Assessment of Cancer Therapy – General (FACT-G) measure, responders in the primary analysis set recorded a mean change of +3.21 from baseline at end of treatment. Non-responders recorded −2.28.
Itch relief reaches 32% of patients with baseline scores of 20 mm or higher
Pruritus was measured on a 100-mm visual analog scale. A clinically meaningful improvement was defined as a decrease of at least 20 mm sustained for four weeks or longer.
"CTCL is a disease of the skin which symptomatic patients must deal with 24/7," said Chief Medical Officer Myron Czuczman, MD.
Exploratory design limits the findings; results are absent from the label
Quality of life was an exploratory objective in the open-label, single-arm, multicenter trial. All analyses were descriptive. The study was not designed or powered to evaluate quality of life outcomes, no formal statistical comparisons were performed, and the results are not included in the LYMPHIR Prescribing Information.
Adult patients with Stage I–III CTCL and at least one prior systemic treatment received LYMPHIR at 9 mcg/kg as a one-hour intravenous infusion on Days 1–5 of each 21-day cycle, for up to eight cycles. The study supported the U.S. Food and Drug Administration approval of the drug, which launched in the U.S. in December 2025.
Safety profile carries a boxed warning for capillary leak syndrome
LYMPHIR carries a boxed warning for capillary leak syndrome (CLS), including life-threatening or fatal cases. CLS occurred in 27% of patients in the pooled safety population, including one fatal case. Infusion-related reactions occurred in 69% of patients, most often in Cycles 1 and 2, and visual impairment occurred in 9%.
Citius Oncology backs Cutaneous Lymphoma Foundation's first quality-of-life workshop
Citius Oncology is partnering with the Cutaneous Lymphoma Foundation on the Foundation's first Quality of Life Workshop, scheduled for November 2026. The meeting will convene patients, care partners, clinicians, researchers, advocacy groups and industry representatives to set priorities and standardize how quality of life is measured in cutaneous lymphoma.
Management estimates the initial CTCL market for LYMPHIR exceeds $400 million.