Pharmaceutical Sector: Data Book - Clinical Trial Data

研报英文原文证据摘录

Pharmaceutical Sector: Data Book - Clinical Trial Data

Kyowa Kirin, Sumitomo Pharma

Competitors of ziftomenib and enzomenib (Menin Inhibitor, Acute Myeloid Leukemia: AML)

Drug Name enzomenib Komzifti (ziftomenib) bleximenib Revuforj

(DSP-5536) (KO-539) (JNJ-75276617) (revumenib, SNDX-5613)

Company Sumitomo Pharma Kura Oncology / Kyowa Kirin Janssen Syndax

Study details

Current Status Ph 1/2 ongoing Marketed P1 ongoing Ph1/2 ongoing Ph1 ongoing Approved (KMT2Ar)/ Ph2 ongoing

Ph2 ongoing (NPM1m)

Trial Name NCT04988555 NCT04067336KOMET-001 NCT05735184KOMET-007 NCT04811560 NCT05453903 AUGMENT-101NCT04065399 BEAT AMLClinicaltrials.gov

Phase Phase 1/2 Ph2 (pivotal) Ph1b/2 Phase 1 Phase 1/2 Phase 1 Phase 1/2

relapsed or refractory relapsed or refractory (2L+) relapsed or refractory (2L+) relapsed or refractory (2L+) relapsed or refractory (2L+) Newly diagnosed (1L) relapsed or refractory Newly diagnosed (1L)

Patient population (2L+) AML AML AML Newly diagnosed (1L) AML (KMT2Ar, NPM1m) AML AML (2L+) AL AML

AML (KMT2Ar, NPM1m, other HOXA9/MEIS1 driven leukemia subsets) (NPM1m) (KMT2Ar, NPM1m) (KMT2Ar, NPM1m) (KMT2Ar, NPM1m) (KMT2Ar, NPM1m) (KMT2Ar, NPM1m)

Combination Combination Combination Combination Combination

Monotherapy/Combination (ventoclax/azacitidine) Monotherapy Monotherapy Combination (ventoclax/azacitidine) (ven/aza) (cytarabine/daunorubicin (7+3)) Monotherapy (cytarabine/daunorubicin (7+3)) Monotherapy (ventoclax/azacitidine)

NPM1mSubgroup KMT2Ar KMT2Ar NPM1m NPM1m NPM1m NPM1m NPM1m KMT2Ar 39% VEN naïve NPM1m NPM1m KMT2Ar NPM1m All KMT2Ar NPM1m All All KMT2Ar NPM1m All All KMT2Ar NPM1m KMT2Ar NPM1m KMT2Ar NPM1m

NPM1m 61% inhibitor azole) (with azole) (with strong CYP3A4 All VEN naïve prior VEN ven naïve ven exp. ven naïve