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Inotuzumab ozogamicin (InO) is a CD22 antibody-drug joint (ADC) that identifies human CD22.
was approved by the FDA on August 17, 2017 for acute lymphoblastic leukemia in adults with relapsed or incurable pre-B cells.
has not yet been listed in China.
, the journal Blood published the results of a Phase I clinical trial in children with the recommended Phase II dose (PR2D) of InO treatment for recurring/recurring (R/R)-CD22-positive acute lymphoblastic leukemia (ALL).
patients (1-18 years of age) received 3 INO doses per course of treatment (days 1, 8, 15).
dose increment is based on dose-limiting toxicity (DLT) during the 1st course of treatment.
dose level 1 (DL1) s 1.4 mg/m2 (0.6-0.4-0.4 mg/m2), DL2 s 1.8 mg/m2 (0.8-0.5-0.5 mg/m2).
end points include safety, anti-leukemia activity, and pharmacodynamics.
recruited a total of 25 patients (23 for DLT evaluation).
at the first course of treatment, 1/6 (DL1) and 2/5 (DL2) patients in the first queue experienced DLT;
the dose to DL1 while waiting for the scenario to be modified to re-evaluate DL2 in the second queue.
in the second queue, DLT occurred in 0/6 (DL1) and 1/6 (DL2) patients.
3-4 adverse events occurred in 23 patients with the most common adverse reactions, and 2 patients reported sinus obstruction syndrome after subsequent chemotherapy.
the total efficiency after the first course of the event-free survival rate (EFS) and overall survival rate (OS) was 80% (20/25 patients; DL1 x 75%, DL2 x 85%); 84% of respondents received a negative CR with minimal residual disease; and a total survival rate of 40% for 12 months.
9 patients received hematopoietic stem cell transplants or chisellular antigen recipient T-cell transplants after InO treatment.
the maximum concentration of inO is comparable to the simulated adult concentration.
good ininO tolerance and showed antileukemia activity in children with a large number of pre-treated CD22-positive R/R ALL.
RP2D is determined to be 1.8 mg/m2/course of treatment, the same as for adults.
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