The latest data according to the eu's new drug approval database, AstraZeneca (AstraZeneca) cancer drugs Lumoxiti (moxetumomab pasudotox) recently approved by the European commission (EC), the drug is a kind of CD - 22 restructuring to poison resistance, is used to treat always has received at least two treatment system (including the purine nucleoside analogues (PNA)) of recurrent or refractory to treatment failure hairy cell leukemia (HCL) in adult patients. In the United States, Lumoxiti was approved for these indications in September 2018, becoming the first drug to be approved for HCL in more than 20 years and marking a major milestone in the clinical treatment of HCL.
The latest data according to the eu's new drug approval database, AstraZeneca (AstraZeneca) cancer drugs Lumoxiti (moxetumomab pasudotox) recently approved by the European commission (EC), the drug is a kind of CD - 22 restructuring to poison resistance, is used to treat always has received at least two treatment system (including the purine nucleoside analogues (PNA)) of recurrent or refractory to treatment failure hairy cell leukemia (HCL) in adult patients. In the United States, Lumoxiti was approved for these indications in September 2018, becoming the first drug to be approved for HCL in more than 20 years and marking a major milestone in the clinical treatment of HCL.
Lumoxiti is an anti-CD-22 recombinant immunotoxin and is a first-in-class innovative treatment for HCl. In October 2018, Innate Pharma SA, a French pharmaceutical company, and AstraZeneca entered into an extended collaboration agreement to mutually facilitate the development of new drugs in the oncology pipeline. Under the terms of the partnership agreement, Innate Pharma will represent the sale of Lumoxiti in the United States and European Union markets. However, on December 11, 2020, Innate Pharma SA announced that it will return the commercialization rights for Lumoxiti to AstraZeneca in the United States and the European Union. The two companies will develop a transition plan with the goal of returning full commercial responsibility to AstraZeneca in 2021, and the parties will ensure access to patients during the transition period. AstraZeneca will remain the marketing authorisation applicant for the EU application for Lumoxiti.
Lumoxiti's approval in the United States and the European Union is based on data from a pivotal phase III clinical Study (Study 1053). This single-arm, multicenter study evaluated the efficacy and safety of Lumoxiti monotherapy in 80 adult patients with relapsed or refractory HCL who received at least two previous regimens. The study was conducted at 34 treatment centers in 14 countries around the world.
Results of the study, presented at the 2019 Annual Meeting of the American Society of Hematology (ASH), showed that the overall response rate (ORR) of Lumoxiti monotherapy was 75% and the lasting complete response rate (CR) was 36% (29/80), defined as a complete response (CR) with hematological response lasting at least 180 days. Eighty-one percent of patients with CR underwent eradication of minimal residual lesions, i.e., MRD negative status. In addition, 61 percent of patients who had achieved CR were likely to maintain CR 5 years later.
HCL is a rare, incurable, slow-progressing chronic lymphoproliferative leukemia characterized by anemia, hemorrhage, splenomegaly, and a large number of irregular, pseudopod or ciliated leukocytes in peripheral blood and bone marrow. HCl can cause serious, life-threatening consequences, including severe infection, bleeding, and anemia.
Immunotoxins are a class of anticancer agents that exploit the selectivity of antibodies to target drug delivery and the ability of toxins to kill cancer cells with potent force. Lumoxiti is produced by the fusion of the binding domain of an anti-CD22 antibody with the toxin. CD22 is a type I transmembrane protein that is mainly expressed in mature B lymphocytes and plays an important role in B cell signaling. The presence of a higher density of CD22 on HCL cells compared to normal B cells makes it a very attractive therapeutic target for HCL treatment. When Lumoxiti binds to CD22, it is internalized, processed and releases modified proteotoxins that inhibit the translation of proteins in the cell, leading to apoptosis. Lumoxiti has been granted Orphan Drug Status (ODD) for the treatment of HCl in both the United States and the European Union, as well as Fast Track status in the United States.
Currently, there is no established standard of care for HCL. Although many patients respond to initial treatment, up to 30% to 40% of patients relapse within five to 10 years after the first treatment. In subsequent treatments, the duration of remission is shortened, toxicity accumulates, and treatment options are few. Lumoxiti represents a very promising non-chemotherapy drug that promises to address a significant unmet medical need in a population of patients with relapsed or refractory HCL.
In terms of medication, the recommended dose of Lumoxiti is 0.04mg/kg BW, given intravenously at > 30 min, on days 1, 3, and 5 of a 28-day cycle, until 6 cycles or disease progression or unacceptable toxicity is treated. It is important to note that Lumoxiti is not recommended for patients with severe renal impairment (creatinine clearance [CRCL] < 29mL).
