Talha Badar, Hematology/Oncology Specialist at Mayo Clinic, shared a post on X about an article Eunice S. Wang and colleagues authored:
“Exciting news for our leukemia patients! Ziftomenib just received FDA approval for relapsed/refractory NPM1-mutated AML.
Brief overview of key data:
1/ Phase II trial (KOMET‑001) treated 92 adults with relapsed/refractory NPM1-m AML using once-daily Ziftomenib (600 mg) monotherapy.
2/ PE: rate of CR/CRh
3/ Results CR/CRh rate: 22%, ORR: 33% ; among responders, 61% achieved undetectable MRD
4/ Median DOR: 4.6 months (range 2.8-7.4 m)
5/ Median OS: 6.6 months (95% CI: 3.6-8.6)
6/ Activity was consistent across subgroups including those with prior venetoclax treatment or co-mutations.
7/ Safety profile: Grade ≥3 febrile neutropenia (26 %), anemia (20 %), thrombocytopenia (20 %).
Differentiation syndrome occurred in ~25 % (15 % were grade 3; no grade 4/5). ”
Title: Ziftomenib in Relapsed or Refractory NPM1-Mutated AML
Authors: Eunice S. Wang, Pau Montesinos, James Foran, Harry Erba, Eduardo Rodríguez-Arbolí, Kateryna Fedorov, Maël Heiblig, Florian H. Heidel, Jessica K. Altman, Maria R. Baer, Lionel Ades, Kristen Pettit, Pierre Peterlin, Cristina Papayannidis, Céline Berthon, Roland B. Walter, Mithun V. Shah, Suresh Balasubramanian, Mohamad Khawandanah, Olga Salamero Garcia, Julie Bergeron, Yazan F. Madanat, Gail J. Roboz, Matthew Ulrickson, Robert L. Redner, James McCloskey, Arnaud Pigneux, Adolfo de la Fuente Burguera, Amitava Mitra, Harris S. Soifer, Marilyn Tabachri, Zijing Zhang, Marcie Riches, Daniel Corum, Mollie Leoni, Ghayas C. Issa, Amir T. Fathi.
Read Full Article on ASCO Publications.
More posts featuring Talha Badar on OncoDaily.