New Post Hoc Analysis from MAVORIC Trial Sheds Light on Burden of Cutaneous T-cell Lymphoma on Health-related Quality of Life

Findings presented at the 65th annual American Society of Hematology meeting in San Diego, CA

PRINCETON, N.J., Dec. 11, 2023 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company based in Japan, today announced health-related quality of life (HRQL) findings from a post hoc analysis of the MAVORIC trial in patients with mycosis fungoides (MF) or Sézary syndrome (SS), two subtypes of cutaneous T-cell lymphoma (CTCL). Researchers analyzed baseline data collected prior to initiation of study treatments and found the symptoms of advanced MF/SS affected HRQL across all domains, with poorer HRQL associated with being younger in age, female, having moderate or severe itching, and impaired function as measured by the Eastern Cooperative Oncology Group performance status (ECOG PS).

"CTCL is a chronic, life-long condition. Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical," said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors. "The data provide new insights into the burdens of living with CTCL, and the patient characteristics associated with a poorer quality of life - important factors to consider when developing a care plan for a patient."

Cutaneous T-cell lymphoma is a rare form of non-Hodgkin's lymphoma that most prominently affects the skin, presenting as patches, plaques, tumors or erythroderma (reddening of the entire skin), and may be associated with severe pruritus (itching). In advanced cases, the disease may spread to the lymph nodes, blood, and/or viscera.

To determine the impact of CTCL on HRQL, researchers analyzed data collected at baseline from 372 MAVORIC trial participants using Skindex-29, which evaluates the effect of skin disease on HRQL; ItchyQol, which is a pruritus-specific measure of HRQL; and the Functional Assessment of Cancer Therapy – General (FACT-G), which measures HRQL in people with cancer. The findings were analyzed at the individual question level and scored according to instrument guidelines. Bivariate analysis (t-tests and ANOVA) was used to identify demographic and medical history variables that had a relationship with HRQL. LASSO (least absolute shrinkage and selection operator) regression analysis was used to identify factors that may drive poor HRQL.

Results show the symptoms of advanced MF/SS affected HRQL across all domains with worse scores seen in Symptoms for Skindex-29, Well-being for FACT-G and Functioning for ItchyQoL. In bivariate analysis, a worse total score across all three HRQL measures was related to being younger, female, having moderate or severe pruritis, ECOG performance status 1 or 2, and higher mSWAT (Modified Severity-Weighted Assessment Tool) scores. In multivariate analysis, worse HRQL was associated with being younger, female, and having moderate or severe pruritus and impaired function (as measured by ECOG PS). Researchers concluded that assessing a patient's disease concerns may help guide treatment goals and therapeutic choice.

About MAVORIC

MAVORIC (Mogamulizumab anti-CCR4 Antibody Versus Comparator In CTCL) was an international, Phase 3, randomized controlled trial that evaluated the safety and efficacy of mogamulizumab versus vorinostat in patients with relapsed or refractory MF or SS (stage IB–IVB) previously treated with at least one systemic therapy.

The study population (N=372) had a mean age of 63 years (SD 13.0). Fifty-five percent of patients had MF, 45% SS, and 77% had advanced disease (stage IIB–IV). The disease involved the skin in all patients and the blood and/or nodes in 66%. ECOG performance status was stage 0, 1, and 2 in 56%, 43%, and <1% of patients, respectively.

POTELIGEO® (mogamulizumab-kpkc) Indication

POTELIGEO injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Important Safety Information

Warnings and Precautions

Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).

Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction.

Infections: Monitor patients for signs and symptoms of infection and treat promptly.

Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease.

Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications.

Adverse Reactions

The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%).

You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information as well as Patient Information.

Disclosure Notice

In line with Good Publication Practices (GPP) the study authors were not compensated for their participation.

Kyowa Kirin provides funding to the Cutaneous Lymphoma Foundation in support of educational initiatives.

About Kyowa Kirin

Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, we apply cutting-edge science including expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about Kyowa Kirin North America at: kkna.kyowakirin.com.

COR-US-POT-0006 Dec 2023

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