Citius Oncology reports quality of life data for LYMPHIR in CTCL at EORTC-CLTG meeting

Citius Oncology, Inc. announced health-related quality of life results on November 4, 2026 from pivotal Study 302 (NCT01871727) of LYMPHIR (denileukin diftitox-cxdl) in adults with relapsed or refractory cutaneous T-cell lymphoma. Christiane Querfeld, MD, PhD, of City of Hope, delivered an oral presentation at the EORTC-CLTG 2026 Annual Meeting, held October 8-10, 2026, in Berlin, Germany.¹

Study 302 is the open-label, single-arm, multicenter registrational trial that supported FDA approval of LYMPHIR, in which adult patients with Stage I-III CTCL who had received at least one prior systemic treatment received LYMPHIR 9 mcg/kg as a one-hour intravenous infusion on Days 1-5 of each 21-day cycle, for up to eight cycles.¹ Quality of life was an exploratory objective assessed with Skindex-29 and FACT-G instruments, with pruritus measured on a 100-mm visual analog scale. All analyses were descriptive, the study was not designed or powered to evaluate quality of life outcomes, no formal statistical comparisons were performed, and these results are not included in the LYMPHIR Prescribing Information.¹

Among findings, responders (n=25) in the primary analysis set (Stage I-III, n=69) showed mean change from baseline in Skindex-29 Total Score ranging from -5.38 to -13.69 points across assessments, compared with slightly positive to near-zero changes among non-responders.¹ FACT-G Total Score showed a sustained benefit among responders, with a mean change from baseline of +3.21 at end of treatment, compared with -2.28 for non-responders.¹ Among 41 heavily pretreated patients with a baseline itch score of 20 mm or greater, 13 (32%; 95% CI, 18.1-48.1) achieved a decrease of at least 20 mm sustained for four weeks or longer.¹

LYMPHIR was approved by the FDA and subsequently launched in the U.S. in December 2025.¹ Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is the majority owner of Citius Oncology (Nasdaq: CTOR).¹ Citius Oncology is also partnering with the Cutaneous Lymphoma Foundation on the Foundation's first-ever Quality of Life Workshop, to be held in November 2026.¹