August 17, 2022

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Poteligeo treats mycosis fungoides (MF) and Sézary syndrome (SS) better

Poteligeo treats mycosis fungoides (MF) and Sézary syndrome (SS) better

 

 

Poteligeo treats mycosis fungoides (MF) and Sézary syndrome (SS) better.  Compared with vorinostat, patients who were treated with Poteligeo (mogamulizumab) and had higher levels of abnormal T cells in the blood reported a higher quality of life!

New data analysis reveals a link between blood involvement and treatment response in cutaneous T-cell lymphoma (CTCL) patients

Compared with vorinostat, patients who were treated with Poteligeo (mogamulizumab) and had higher levels of abnormal T cells in the blood reported a higher quality of life!

Kyowa Kirin International PLC (Kyowa Kirin), a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., announced a new data analysis showing that, compared with vorinostat, mogamulizumab is involved in blood treatment of skin T-cell lymphoma (CTCL) There is a statistically significant improvement in the quality of life of patients.

The new findings of the MAVORIC trial compare the effects of POTELIGEO® (mogamulizumab) and vorinostat treatment on the blood tumor burden of two types of CTCL adult patients with mycosis fungoides (MF) and Sézary syndrome (SS).

Professor Pier Luigi Zinzani from the Institute of Hematology “L. e A. Seràgnoli” at the University of Bologna said: “This new analysis helps us understand more about the importance of blood involvement in CTCL, which is important for more diseases. Advanced stage, and may exist in some less advanced cases. We know that the increase in the level of malignant T cells in the blood is associated with an increased risk of CTCL disease progression and an overall decrease in patient survival. Mogamulizumab treatment has also been shown to be involved in blood involvement. CTCL patients with part of the disease are more effective, and Mogamulizumab treatment also brings quality of life benefits to CTCL patients with blood involvement.


In the study, patients classified as B0 were considered to have no blood involvement, while patients classified as B1 and B2 were considered to have blood involvement. B1 is a measurable low-level blood involvement, with 250 to 1000 abnormal T cells per microliter. B2 is a higher level of blood involvement, with more than 1,000 abnormal T cells per microliter, which is detected by flow cytometry.

There was a statistically significant difference in the quality of life of blood-affected patients. Compared with vorinostat, patients treated with mogamulizumab saw improvements in the Skindex-29 and ItchyQoL questionnaires. Compared with vorinostat, the quality of life of patients treated with Mogamulizumab also improved, and blood involvement was assessed by the Likert Scale for Pruritus and FACT-G Total Score Questionnaires. For patients without blood involvement, there was no statistically significant difference in the quality of life between mogamulizumab and vorinostat.

MF and SS are subtypes of CTCL. CTCL is a rare non-Hodgkin lymphoma that can affect the skin, blood, lymph nodes, and internal organs. As a chronic and generally incurable disease related to disfiguring skin lesions, intractable pruritus, sleep disorders and psychosocial problems, CTCL has a serious negative impact on the quality of life. MAVORIC is the largest multinational, randomized, phase 3 trial of systemic CTCL treatment. MAVORIC evaluated the safety and effectiveness of mogamulizumab and vorinostat in patients who have previously received at least one systemic treatment. This new post-mortem analysis of the MAVORIC trial uses a series of recognized and validated assessment tools to look at data on the patient’s quality of life.

The MAVORIC trial reached the primary endpoint of overall progression-free survival (PFS) assessed by the investigator. Compared with vorinostat, patients treated with mogazizumab had significantly higher PFS at 7.7 months and 3.1, respectively. Months (P <0.0001).

About Mycosis Fungoides (MF) and Sézary Syndrome (SS)

Cutaneous T-cell lymphoma (CTCL) is a rare, serious, and potentially life-threatening non-Hodgkin’s lymphoma, affecting approximately 240 people per 1,000,000 population in Europe. Mycosis fungoides (MF) and Sézary syndrome (SS) are the two best-studied types of CTCL, and together they account for approximately two-thirds of all CTCLs.

MF and SS affect the skin, blood, lymph nodes (part of the body’s immune system, distributed throughout the body) and internal organs. MF and SS can be very painful for patients and have a significant negative impact on patients’ lives in many aspects. The disease stage of MF and SS is the most important prognostic factor, depending on the type and degree of skin involvement, and whether there are extracutaneous diseases in the lymph nodes, internal organs, and blood. Therefore, it is recommended to first evaluate all four anatomical “compartments” at the time of diagnosis, and then evaluate the patient’s response to treatment.

The tumorous T lymphocytes in MF and SS always express CC chemokine receptor 4 (CCR4), making it a relevant target for treatment in all disease stages. All disease stages may include blood involvement, and blood tumor burden may be related to the prognosis and treatment of MF and SS.

Because it is similar to more common skin diseases such as eczema and psoriasis, CTCL takes an average of 2 to 7 years for an individual to be diagnosed. For doctors, it is important to diagnose CTCL as early as possible, because if the disease progresses to the later stage, the patient’s prognosis may be affected. Although most early-stage patients do not progress to more advanced stages, the prognosis of 18 patients with advanced disease is significantly worse, and only about half (52%) of the patients survived for only 5 years.

About the POTELIGEO (mogamulizumab) and MAVORIC trials

POTELIGEO (mogamulizumab) is a humanized monoclonal antibody that selectively binds to CCR4 and induces anti-tumor activity through antibody-dependent cellular cytotoxicity (ADCC).

According to the positive opinions of the European Medicines Agency (EMA) Committee for Human Medicines (CHMP), the European Commission (EC) granted marketing authorization for mogamulizumab in November 2018 for the treatment of adult patients with MF or SS who have received at least one Previous systemic treatment. CHMP’s opinion is based on the results of the MAVORIC trial, which is the largest randomized study of systemic therapy for MF and SS, and the first trial to compare systemic therapy with progression-free survival as the primary endpoint.

MAVORIC evaluated the safety and effectiveness of mogamulizumab and vorinostat in patients who had previously received at least one systemic treatment:

Compared with vorinostat, Mogamulizumab more than doubled the median progression-free survival (PFS) of patients with relapsed or refractory MF/SS (7.7 months vs 3.1 months), a relative decrease of 47% The risk of disease progression (HR=0.53), 95% CI: 0.41–0.69; P<0.0001).

Overall, the response to mogamulizumab was significantly higher than that of vorinostat (overall response rate [ORR] 28.0% and 4.8% (P<0.0001)).

Compared with patients treated with vorinostat, the median time to next treatment (TTNT) of patients treated with mogizumab is an additional measure of clinical benefit and disease control (11.0 months vs. 3.5 Month; P <0.0001).

In post-hoc analysis, patients with blood tumor burden levels B1 and B2 who received mogamulizumab received significantly more benefits in terms of improvement in PFS, TTNT, and mSWAT compared to patients who received vorinostat.

Mogamulizumab shows good tolerability and controllable safety.

 

(source:internet, reference only)


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