Business
Curis Announces Positive Updated Data from Ongoing Phase 1/2 Study of CA-4948 Monotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia and Myelodysplastic Syndromes
- Updated data show marrow blast reductions in 10 out of 12 evaluable patients with elevated blast counts at baseline - - 5 objective responses observed,
About this update from Curis, Inc.
[{"type":"text","content":"- Updated data show marrow blast reductions in 10 out of 12 evaluable patients with elevated blast counts at baseline -\n - 5 objective responses observed, including 1 complete response (CR), 1 complete remission with incomplete hematologic recovery (CRi) and negative minimal residual disease, 1 partial response (PR), and 2 marrow CRs -\n - 300mg BID, the dose currently used in ongoing Lymphoma and lower-risk MDS studies, confirmed as the recommended Phase 2 dose in AML and high-risk MDS -\n - Management to host virtual KOL event today, Friday, June 11 at 8:00 a.m. ET -\n\n\nLEXINGTON, Mass., June 11, 2021 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced updated data from its ongoing Phase 1/2 open-label, single arm, dose escalation and expansion trial of CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) at the European Hematology Association 2021 Virtual Congress (EHA). \n\n \n \n \n \n \n \n\n \n\"As we have observed increasingly mature sets of data, we continue to be pleased by the steady progression of clinical activity demonstrated by CA-4948 monotherapy in this historically difficult-to-treat late-line population,\" said James Dentzer, President and Chief Executive Officer of Curis. \"We believe these updated data further support the growing body of evidence that CA-4948's anti-cancer activity continues to deepen the longer patients remain on drug, which is enabled by its safety and durability profile to date. Further, after backfilling patient cohorts and evaluating additional data after the April 30, 2021 cut-off date for today's presentation, we have concluded 300mg BID is the optimal dose to take into Phase 2 studies.\"\nMr. Dentzer added, \"We are especially pleased with the outcomes seen to date for patients with spliceosome or FLT3 mutations. All three patients with a spliceosome mutation achieved an objective response. The FLT3 patient also achieved an objective response and, after two cycles of CA-4948, the patient's FLT3 mutation was found to be completely eradicated. While these are early days, and we have a limited set of patient data, we are very encouraged about the potential CA-4948 may have to b...