Global Development: Roche LUNSUMIO approved to treat recurrence or refractory follicular lymphoma

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Global Development: Roche LUNSUMIO approved to treat recurrence or refractory follicular lymphoma

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On June 8, 2022, the European Commission has granted CD20XCD3 bispecific antibody LUNSUMIO (Mosunetuzumab) with conditional listing permits for the recurrence or refractoryness (R/ R/ R) Filtering lymphoma (FL). Its approval is based on the approval of GO29781 research results, showing that in patients with severe filtering lymphoma, the complete relief of LUNSUMIO has continued for at least 18 months. LUNSUMIO is the first CD20XCD3 T cell that can be used to treat the most common form of slow growth form for the treatment of the most common form of slow growth. The new type of immunotherapy of the ready -made, fixed treatment can improve the treatment results of patients with recurrence or patients with difficulty cure in the past.

GO29781 is a multi -centered, open label, dose increase and expansion test of phase I/II. Student characteristics. The main endpoints include the complete reaction rate (optimal reaction) determined by the independent review agency, and the secondary endpoint includes objective reactions, reaction duration, no progressive survival period, safety and tolerance.

Studies have shown that LUNSUMIO shows a high and complete alleviation rate. Most of the complete relievals have maintained time for at least 18 months, and have good tolerance for patients with a large number of pre -processing FL. After the median follow -up 18.3 months, the median reaction duration of the relieving person was 22.8 months, the full response rate was 60% (n = 54/90), and the objective response rate was 80% (n = 72/90).

The most common adverse event is cytokine release syndrome (39%), usually low levels (level 2: 14%), and fades at the end of the treatment; other common (≥20%) AE , Fever, low phosphorusmia and headache.

Lunsumio aims to target CD20 on the surface of B cells and CD3 on the surface of T cells. Through dual targeting activation and redirect to the patient’s existing endogenous T cells, the cytotoxic protein is released to B cells to eliminate malignant B cells. It is currently being used as a single therapy or combined with other drugs to treat adult B -cell non -Hodgkin lymphoma, including filtering lymphoma, diffuse large B -cell lymphoma (DLBCL), and other blood cancer. Two III studies in the process of ongoing include FL (CELESTIMO) for combined Laibamine second -line therapy, as well as combined with Polivy second -line therapy DLBCL (Sunmo).

FL is the second common non -Hodgkin lymphoma (NHL), as an inert lymphoma, accounting for about 22%of NHL cases. About 20%of patients will develop diseases within 2 years after receiving first -line treatment. The latest epidemiological data shows that the median age of its onset is 64.9 years. my country shows a younger trend of onset, FL accounts for about 8.1%-23.5%of NHL, and the incidence of coastal and economically developed areas is higher. At present, FL’s median overall survival period exceeds 10 years, and 60%-70%of cases are diagnosed with bone marrows. About 1/3 can be converted to DLBCL. The clinical course is slow, but it cannot be cured.

Both bilateral can combine two different targets at the same time, one of which directly combine with a specific antigen on the cancer cells, on the other hand, activating the T cells in the patient’s own immune system and getting it closer to cancer cells and killing it. Due to functional improvement, double resistance compared to monoclonal resistance and has a more complicated structure.

Its clinical value is

The

1) Compared with two monoclonal combination, potential safety optimization, efficacy optimization, and cost of technical maturity have decreased.

2) Through the new function -bridge, immune cells can be recruited directly to play a stronger killing role. There is also the function of crossing the blood -brain barrier to be developed.

3) Based on the new function -combined with the two targets on a cell, it can play a role of dual signal blocking to prevent the activation of bypass signals.

Double antibody drug differences

At present, 5 double resistance worldwide has been approved for listing. The specific information is as follows:

According to Floristian data, the global monoclonal scale in 2020 was US $ 174.9 billion, and the industry growth rate was expected to be 4.2%from 2024-2030. In 2020, the market size of the double-resistance industry was 2.5 billion US dollars, and the industry growth rate was expected to be 29.3%in 2024-2030. The growth rate of the double anti -industry is higher than the monoclonal resistance.

Global dual -anti/monoclonal drug market size and growth rate

(Unit: billion US dollars)

It is estimated that China’s dual-resistant market will reach US $ 10.8 billion in 2030, and the growth rate of 54.3%in 2024-2030; the monoclonal market size is US $ 57.9 billion, and the growth rate of 2024-2030 is 16.7%. The growth rate of the dual anti -industry is higher than the monoclonal resistance.

China’s dual -resistant/monoclonal anti -drug market size and growth rate

(Unit: billion US dollars)

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