Misc 1
Biologics by McKesson
Optime Care Pharmacy
What are the 2 SP for Rezlidhia?
Rate of CR/CRh
What was the Primary Endpoint for Study 2102-HEM-101?
97 (66%)
50 (34%)
What are number and percentages of AML patient types of de novo and secondary?
150 BID 1 hour before, 2 hours after
What is the dosing schedule for Rezlidhia.
153 Adults
What is the total # of patients to receive Rezlidhia for R/R AML with IDH1 mutation that were evaluated for safety in our Clinical Trials.
86 (59%)
How many patients where Transfusion Dependent at Baseline?
ORR
Duration of CR/CRh
DOR
Rate of Transfusion independence
OS
Safety
What were the Secondary Endpoints for Study 2102-HEM-101?
16 out of 147 (11%)
What are the number of patients that underwent Stem Cell transplantation following Treatment with Rezlidhia for R/R AML with IDH1 mutation?
8%
What are the percentage of patients that permanently d/c'd Rezlidhia due to adverse reactions.
1.9 Months
5.5 Months
What was the median time to CR/CRh?
And What was the median time for All patients that achieved best response?
Favorable 4%
Intermediate 73%
Poor 17%
Unknown 6%
What are the AML cytogenetic categorys?
6.2 miliseconds
What is the largest mean increase in QTc interval in 33 patients
Treatment with Hydroxyurea
What to do for patients with noninfectious leukocytosis
32%
What percentage of the study population had to have dosage interruptions due to adverse reactions.
25.9
What was the Median Duration of Response for those responders?
12 Patients
What are the number of Patients that were Treated with Venetoclax-based thereapy prior to receiving Rezlidhia?
Wild-Type IDH1 or Mutated IDH2 proteins
Which mutations in AML were not inhibited by Rezlidhia?
Withhold Rez. and monitor liver function test twice a week until values return to baseline or grade 1.
Resume Rez at 150mg 1x qd for 1 month. Then increase to BID if liver functions aren't elevated.
What actions you should take if patients experience Hepatotoxicity?
dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever and weight gain.
What are the symptoms of Differentiation Syndrome?
51 or 35%
What were the numbers of CR+CRh in the study population?
33% & 50%
What are the Clinical Response Rates for the 12 pt subgroup that were treated with Venetoclax-based therapy prior to receiving Rezlidhia?
R132H & R132C Substitutions
What are the 2 most common mutations in patients with AML?
Grade 4 Hepatotoxicity
What is the level of hepatotoxicity that Rez. should be discontinued?
16% & 8%
23% & 13%
What are the overall percentages of grade 3/4 of Differentiation Syndrome and Hepatotoxicity?