NEW YORK – Sumitomo Dainippon Pharma Oncology said on Friday that it has dosed the first patient with the combination of its AXL kinase inhibitor dubermatinib (TP-0903) and the chemotherapy decitabine in the Phase Ib/II Beat AML Master Clinical Trial.
The Leukemia & Lymphoma Society launched the Beat AML study in 2016, aiming to advance new precision therapies for those 60 or older and treatment naive. The study has already demonstrated the feasibility of applying a rapid precision medicine approach to match patients to treatments based on the molecular profile of their cancers, and researchers have shown that those who received personalized drugs lived significantly longer than those who received standard-of-care treatments.
The umbrella trial is continuing to explore biomarker-guided treatments and added the dubermatinib-chemo subprotocol in March. This cohort of the study is enrolling newly diagnosed AML patients 60 or older who have TP53 mutations, as well as those with a complex karyotype.
TP53 mutations occur in 5 percent to 19 percent of AML patients, who often respond poorly to chemotherapy and rarely experience long-term survival after stem cell transplants.
Sumitomo's aim in the subprotocol is to determine the safety and maximum tolerated dose of the combination regimen and evaluate patients' composite complete response rate. Researchers will also track overall survival and the proportion of patients who transition to allogeneic stem cell transplantation.
"Although there have been recent advances in the treatment of AML, for patients with certain types of mutations, prognosis and responsiveness to therapy remain poor," Sumitomo CEO Patricia Andrews said in a statement. "Therefore, dosing the first patient in this study represents an important milestone for patients with AML who have TP53 mutations."
Dubermatinib was originally developed by Tolero Pharmaceuticals, a subsidiary of Sumitomo Dianippon Pharma. In July, the Japanese pharmaceutical company merged its subsidiaries Tolero and Boston Biomedical to create Sumitomo Dainippon Pharma Oncology. The company is also studying dubermatinib in other solid and hematologic malignancies.