Rezlidhia

Question 1

Generic Rezlidhia?

Answer 1

olutasidenib

Question 2

Rezlidhia Indication?

Answer 2

indicated for trx of adult pts with R/R AML with IDH1 mutation as detected by an FDA approved test.

Question 3

What was clinical trial that led to Rezlidhia approval?

Answer 3

2102-HEM-101, Open label, single arm, multi-center trial

Question 4

Patient population in Rezlidhia pivotal trial?

Answer 4

18 yrs+, R/R AML, Confirmed IDH1 mutation, no prior IDH1 therapy, ECOG PS 0-2

Question 5

How many patients in Rez pivotal trial?

Answer 5

N= 153

Question 6

Rez pivotal trial dosing?

Answer 6

150mg, PO, bid, for at least 6 months until disease progression or unacceptable toxicity

Question 7

Rez pivotal trial Clinical Endpoints?

Answer 7

Primary: CR/CRh
Secondary: ORR, Duration of CR/CRh, DOR, Rate of transfusion independence (TI), OS, Safety

Question 8

What is CRh?

Answer 8

Complete Remission hematologic = less 5% bone marrow blasts, anc >500, platelets >50,000

Question 9

Rez pivotal trial median age?

Answer 9

71 years old

Question 10

Rez pivotal trial % refractory to previous trx?

Answer 10

31%

Question 11

Rez pivotal trial median # of prior treatments?

Answer 11

2 (1-7 range)

Question 12

Rez pivotal trial what % of patients had a prior stem cell transplant for AML?

Answer 12

12% (17)

Question 13

Rez pivotal trial % of patients transfusion dependent at baseling?

Answer 13

59% (86)

Question 14

Rez pivotal trial what % pts achieved a Clinically Meaningful Response?

Answer 14

48% includes: CR, CRh, CRi, PR, MLFS

Question 15

Rez pivotal trial % of patients achieved primary endpoint?

Answer 15

CR/CRh = 35% with 32% at CR

Question 16

Rez pivotal trial Did prior venetoclax skew RR?

Answer 16

RR were similar in pts who had veneto vs those didn’t

Question 17

Rez pivotal trial % of patients that became transplant eligible on Rez

Answer 17

11% (16 of 147)

Question 18

5/2025 NCCN category for Rez

Answer 18

Recommended

Question 19

Rez pivotal trial MDR in pts achieving CR/CRh? Those got CR?

Answer 19

Over 2 years
25.9 months
28.1 months

Question 20

Rez pivotal trial Median OS:
CR/CRh
Other Responders
Non responders

Answer 20

OS - 11.6
CR/CRh - NR (22.8-NE)
Other R - 13.7 months
Non Resp - 4 months

Question 21

Rez pivotal trial Estimated 18 month survival for CR/CRh?

Answer 21

78 months

Question 22

Rez PI Warnings & Precautions?

Answer 22

Boxed warning-Differentiation Syndrome
Hepatotoxicity

Question 23

Rez basic MOA

Answer 23

Small molecule that Inhibits mutant IDH1 and restores myeloblast differentiation

Question 24

Rez pivotal trial most common AE’s

Question 25

Rez pivotal trial discontinuation rate due to AE's?

Answer 25

8% transaminitis, differentiation syndrom, gallbladder disorders

Question 26

Rez pivotal trial grade 5 AE's?

Answer 26

Yes, 1 fatality due to differentiation syndrom

Question 27

Rez pivotal trial %/# of pts experienced diff syndrome and %/# recovered?

Answer 27

16%/25 pts had it 76%/19 pts recovered after trx or dosage interruption

Question 28

Rez pivotal trial % pts experienced hepatotoxicity?

Answer 28

23% 13% grade 3/4

Question 29

Rez pivotal trial had QT prolongation?

Answer 29

8% with none leading to reduction or DC

Question 30

Rez pivotal trial dosing?

Answer 30

1 150mg capsule PO 2x day until disease progression or unacceptable toxicity. Take about the same time each day more than 8 hrs apart.