On November 4, 2026 Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR) reported health-related quality of life (HRQoL) results from pivotal Study 302 (NCT01871727) of LYMPHIR (denileukin diftitox-cxdl) in adults with relapsed or refractory (r/r) cutaneous T-cell lymphoma (CTCL). Christiane Querfeld, MD, PhD, of City of Hope, delivered an oral presentation at the European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) 2026 Annual Meeting, held October 8–10, 2026, in Berlin, Germany.

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"Patients and physicians have told us that both clinical response and quality of life matter in CTCL treatment," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "These data add the patient’s voice to the efficacy and durability shown in our pivotal trial. We were pleased to share the data at the EORTC-CLTG conference in Berlin and are proud to partner with the Cutaneous Lymphoma Foundation on its November 2026 workshop to put quality of life at the center of CTCL care."

"CTCL is a disease of the skin which symptomatic patients must deal with 24/7. Painful, itchy lesions take a real toll on their well-being," said Dr. Myron Czuczman, Chief Medical Officer of Citius Oncology. "In Study 302, patients who responded to denileukin diftitox-cxdl reported sustained quality of life improvements, and nearly a third of heavily pretreated patients with significant itch noted its decrease. We believe these findings underscore how important quality of life considerations are as practitioners choose between various treatment options for their patients with relapsed or refractory CTCL."

Study 302 is the open-label, single-arm, multicenter registrational trial that supported the U.S. Food and Drug Administration (FDA) approval of LYMPHIR. 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.

Quality of life was an exploratory objective, assessed with two validated patient-reported outcome (PRO) instruments: the disease-specific Skindex-29 and the general Functional Assessment of Cancer Therapy – General (FACT-G). Pruritus was measured on a 100-mm visual analog scale (VAS). 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.

Key findings included:

● Skin-related quality of life: Among responders (n=25) in the primary analysis set (Stage I-III, n=69), 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 scores indicate better quality of life). In the full analysis set (Stage I–IV, n=81), sustained quality of life improvements among responders over non-responders were consistent across all three Skindex-29 domains: symptoms, emotions, and functioning.

● Overall quality of life: Among responders in the primary analysis set, FACT-G Total Score showed a sustained benefit at the end of treatment, with a mean change from baseline of +3.21 at the end of treatment, compared with −2.28 for non-responders.

● Pruritus: 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 clinically meaningful improvement, defined as a decrease of at least 20 mm sustained for four weeks or longer.

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. The working meeting will bring together patients and care partners, clinicians, researchers, advocacy organizations, and industry representatives to set priorities, standardize how quality of life is measured in cutaneous lymphoma, and build a shared roadmap for patient care and well-being. More information about the workshop is available at www.clfoundation.org/quality-life-workshop.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a targeted immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I–III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing DT fragments that have entered cells to inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl has demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors. LYMPHIR was approved by the FDA and subsequently launched in the U.S. in December 2025. For more information, please visit www.lymphirhcp.com.

(Press release, Citius Pharmaceuticals, NOV 4, 2026, View Source [SID1234674162])