Announced details
Third- and fourth-line treatment for relapsed/refractory acute myeloid leukemia (R/R AML), and second-line treatment and later
Monotherapy: The objective response rate (ORR) exceeded that of the control group, and overall survival (OS) was longer in a stratified analysis against the intensive therapy group. VEN combination therapy: 50% response rate in Phase 1, 53% response rate in Phase 2, and 4 patients proceeding to hematopoietic stem cell transplantation
In the VEN combination trial, Phase 1 included 1 patient with CR and 2 with MLFS, while Phase 2 included 3 with CRi, 3 with MLFS and 3 with PR. 4 patients proceeded to hematopoietic stem cell transplantation, and 3 patients remain on treatment.
The Company is consulting with the FDA regarding the marketing application and preparations for a Phase 3 trial. The Company has entered into confidentiality agreements with major overseas pharmaceutical companies and others and is providing detailed information. Joint development and joint advancement may be pursued in the future.
The FDA is the U.S. drug regulatory authority. The locations, representatives, businesses, stated capital and years of establishment of the major overseas pharmaceutical companies and others are not disclosed.
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
| Item | Details |
|---|---|
| Names of Products / Services Covered | DFP-10917, Venetoclax (VEN) combination therapy |
| Counterparty | U.S. Food and Drug Administration (FDA) and major overseas pharmaceutical companies and others (names not disclosed) |
| Counterparty overview | The FDA is the U.S. drug regulatory authority. The locations, representatives, businesses, stated capital and years of establishment of the major overseas pharmaceutical companies and others are not disclosed. |
| Relationship with the Company | The Company is consulting with the FDA regarding the marketing application and preparations for a Phase 3 trial. The Company has entered into confidentiality agreements with major overseas pharmaceutical companies and others and is providing detailed information. Joint development and joint advancement may be pursued in the future. |
| Applicable area | Third- and fourth-line treatment for relapsed/refractory acute myeloid leukemia (R/R AML), and second-line treatment and later |
| Quantitative Effects | Monotherapy: The objective response rate (ORR) exceeded that of the control group, and overall survival (OS) was longer in a stratified analysis against the intensive therapy group. VEN combination therapy: 50% response rate in Phase 1, 53% response rate in Phase 2, and 4 patients proceeding to hematopoietic stem cell transplantation |
| Usage history | In the VEN combination trial, Phase 1 included 1 patient with CR and 2 with MLFS, while Phase 2 included 3 with CRi, 3 with MLFS and 3 with PR. 4 patients proceeded to hematopoietic stem cell transplantation, and 3 patients remain on treatment. |
Items this document does not state (11)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.In the interim analysis of the Phase 3 monotherapy trial, the objective response rate exceeded that of the control group, overall survival was longer in a stratified analysis against the intensive therapy group, and efficacy was suggested in the patient population with poor-prognosis genetic mutations, including TP53. In addition, results were obtained in the VEN combination trial, including the response rate and the number of patients proceeding to hematopoietic stem cell transplantation.