Business Wire

KYOWA-KIRIN

11.12.2023 15:01:37 CET | Business Wire | Press release

Share
New Post Hoc Analysis from MAVORIC Trial Sheds Light on the Burden of Cutaneous T-Cell Lymphoma on Health-Related Quality of Life

Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co. Ltd, 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 analysed baseline data collected prior to initiation of study treatment 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, tumours or erythroderma (reddening of the 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 analysed data collected at baseline from 372 MAVORIC trial participants using Skindex-29, which evaluates the effect of skin disease on HRQL; the 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 analysed 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 were 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, 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, open label, Phase 3, randomised controlled trial that evaluated the safety and efficacy of Poteligeo® (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.

To view the full press release, click here.

KKI/INT/MOG/1002

Date of preparation: December 2023

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231211833501/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

EVE Energy Showcases All-Scenario Energy Storage Solutions at The Smarter E Europe 20261.7.2026 03:45:00 CEST | Press release

EVE Energy unveiled its Mr. Big Family series, a 6.9+ MWh energy storage system, and all-scenario energy storage solutions at Intersolar Europe in Munich. Drawing on traceable large-cell technology, proven large-scale energy storage project delivery experience, and global delivery capabilities, the company is addressing Europe's diverse energy storage requirements across utility-scale, commercial & industrial (C&I ), and data center segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260630889717/en/ EVE Energy showcases its Mr. Giant 3.0 6.9+ MWh energy storage system at The Smarter E Europe 2026 in Munich, Germany Advancing Large-Cell Technology with Global Project Validation As one of the first companies to focus on large-capacity energy storage cells, EVE Energy has iteratively upgraded its cell platform from 560 Ah and 628 Ah to 702 Ah, adhering to a stacking process route throughout. At the exhibition, the Mr. Gia

Bending Spoons S.p.A. announces pricing of initial public offering1.7.2026 01:56:00 CEST | Press release

Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the pricing of its initial public offering (“IPO”) at $29.00 per share. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 shares are being offered by Bending Spoons and 23,572,375 shares are being offered by certain selling shareholders (the “Selling Shareholders”). Bending Spoons will not receive any proceeds from any sale of shares by the Selling Shareholders. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “BSP” on July 1, 2026. The offering is expected to close on July 2, 2026, subject to customary closing conditions. In addition, Bending Spoons and the Selling Shareholders granted the underwriters an option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and up to an additional 3,451,626 ordinary shares from the Selling Shareholders at the initial public offering price, less underwriting

FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 18:19:00 CEST | Press release

FDA’s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease

Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 17:00:00 CEST | Press release

Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border

Archer® Proves Purpose-Built AI Beats General-Purpose LLMs on Regulatory Change Management: 95% Verified Accuracy, 80x Faster, 92% Lower Cost30.6.2026 16:13:00 CEST | Press release

In a head-to-head benchmark, a leading general-purpose LLM was confidently wrong 35% of the time on regulatory dates. Archer Evolv™ shipped zero errors. For enterprises deploying AI in compliance, a wrong date is a missed deadline. The more dangerous failure is a wrong answer the model returns with high confidence, one that flows silently into a compliance calendar and is only discovered after the window has passed. Archer® today released results showing purpose-built AI beats a general-purpose large language model (LLM) on regulatory work, and it’s not close. This head-to-head test compared Archer’s purpose-built, vertical-specific AI and proprietary data sets against a leading general-purpose LLM, on a core compliance task: determining the publication, effective and comment-close dates of regulatory documents across six jurisdictions. General-purpose models are a genuine breakthrough, and this is no referendum on their quality. The question Archer set out to answer is narrower and mo

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye