Citius Reports LYMPHIR Quality-of-Life Improvements in CTCL

Citius Oncology announced on November 4, 2026, that exploratory health-related quality-of-life (HRQoL) findings from pivotal Study 302 of LYMPHIR® (denileukin diftitox-cxdl) showed improvements in skin-related quality of life, overall well-being, and itching among clinical responders with relapsed or refractory (r/r) cutaneous T-cell lymphoma (CTCL). The findings were presented in an oral session by Christiane Querfeld, MD, PhD, of City of Hope, at the European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) 2026 Annual Meeting in Berlin, held October 8–10.

CTCL is a rare type of non-Hodgkin lymphoma that primarily affects the skin. Beyond visible lesions, the disease can cause persistent itching, skin discomfort, and emotional and functional challenges that substantially affect patients’ quality of life. These effects are particularly relevant in r/r disease, where assessing treatment outcomes requires consideration of both clinical response and patients’ everyday experiences.

The newly reported findings add a patient-centred dimension to the clinical evidence for LYMPHIR, although the HRQoL analyses were exploratory and were not designed to establish a definitive treatment-related quality-of-life benefit.

Trial Design and Patient Population

Study 302 (NCT01871727) was an open-label, single-arm, multicenter registrational trial that supported U.S. Food and Drug Administration (FDA) approval of LYMPHIR. It enrolled adults with Stage I–III CTCL who had received at least one prior systemic treatment. Participants 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.

HRQoL was an exploratory objective assessed using two validated patient-reported outcome instruments: Skindex-29, which measures skin-related quality of life, and the Functional Assessment of Cancer Therapy-General (FACT-G), which evaluates broader well-being. Pruritus was measured using a 100-mm visual analog scale (VAS).

All analyses were descriptive. The study was not designed or powered to evaluate HRQoL, and no formal statistical comparisons were performed. These findings are not included in the LYMPHIR Prescribing Information.

Key Patient-Reported Outcomes

Skin-Related Quality of Life

Among 69 patients in the primary analysis set (Stage I–III), 25 were classified as responders. Their mean change from baseline in Skindex-29 Total Score ranged from −5.38 to −13.69 points across assessments, compared with slightly positive to near-zero changes among non-responders. Lower Skindex-29 scores indicate better quality of life, suggesting improvements in skin-related well-being among responders.

The broader full analysis set included 81 patients with Stage I–IV disease. The pattern favouring responders was consistent across all three Skindex-29 domains: symptoms, emotions, and functioning. These findings highlight the potential relevance of treatment response to different dimensions of the daily burden associated with CTCL.

Improvements in Overall Well-Being

FACT-G provided a broader assessment of patient-reported quality of life. Among responders in the primary analysis set, the mean change from baseline in FACT-G Total Score was +3.21 points at the end of treatment, compared with −2.28 points among non-responders.

The difference in direction suggests that clinical response may coincide with improvements extending beyond skin-related symptoms. However, these descriptive findings do not establish a statistically significant difference between the groups.

Sustained Improvement in Itching

Among 41 heavily pretreated patients with baseline itch scores of at least 20 mm, 13 patients (32%; 95% confidence interval [CI], 18.1–48.1) achieved a clinically meaningful improvement in pruritus.

Improvement was defined as a reduction of at least 20 mm on the VAS, sustained for four weeks or longer. Although the finding indicates meaningful itch reduction in a subset of patients, the 32% result applies only to this selected subgroup and should not be generalized to the entire Study 302 population.

Clinical Interpretation: Encouraging Signals, Not Confirmatory HRQoL Evidence

The findings add a patient-centred dimension to the clinical evidence for LYMPHIR. Improvements in Skindex-29 scores among responders, favourable changes in FACT-G, and sustained itch reduction in a selected subgroup suggest that clinical response may accompany better patient-reported well-being.

However, important limitations remain. HRQoL was exploratory, and the trial was neither designed nor powered to evaluate these outcomes. All analyses were descriptive, without formal statistical comparisons. Furthermore, the open-label, single-arm design prevents firm conclusions that LYMPHIR caused the observed changes or that differences between responders and non-responders represent treatment effects.

Accordingly, these findings should be viewed as supportive, hypothesis-generating evidence rather than definitive proof of a quality-of-life benefit. Further studies incorporating prospectively specified HRQoL endpoints and appropriate comparative analyses would help establish the magnitude and durability of any treatment-related benefit.

For clinicians, the results reinforce the importance of considering symptoms, emotional well-being, and daily functioning alongside conventional measures of disease response when evaluating treatment outcomes in r/r CTCL.

References

Citius Oncology’s Positive Quality of Life Data for LYMPHIR® (denileukin diftitox-cxdl) in Relapsed or Refractory Cutaneous T-Cell Lymphoma Presented at Premier Global CLTG Congress in Europe, Citius Oncology, 04 November 2026

A Trial of E7777 in Persistent and Recurrent Cutaneous T-Cell Lymphoma, ClinicalTrials.gov ID NCT01871727