Kura Oncology Drugs in ASCO Supports Data in FDA Documents in Prioritization of Leukemia
The drug competition between KURA Oncology and Kyowa Kirin is the first FDA-approved treatment for acute myeloid leukemia (AML) carrying a specific genetic signature, whose regulatory review will be supported by clinical data showing that the treatment has a statistically significant improvement in the signs and symptoms of the disease. However, the companies continued to reveal the details of the results until the data was fully introduced during the annual meeting of the American Society of Clinical Oncology in Chicago this week.
The kura drug Ziftomenib is part of a novel therapy designed to stop Menin, Menin, a protein that supports the growth of leukemia cancer. Kula’s oral small molecule is designed specifically to address leukemia characterized by mutations in the NPM1 gene, and San Diego’s biotechnology says the gene accounts for 30% of all AML cases.
The 2nd phase of the open-label period 1/2 study included 92 adults with mutations in NPM1 in AML. These patients suffer from a disease that relapses or does not respond to earlier therapy. About 33% of study participants have received three or more prior treatments, while 59% of study participants have previously received treatment with the cancer drug venclexta, which is sold by Abbvie and Genentech. Also included are those that do not qualify for other leukemia treatments, such as hematopoietic stem cell transplantation.
Ziftomenib is used as a pill once a day. According to results presented at the ASCO meeting on Monday, the drug had a response rate of 23% in the critical phase 2 part of its trial – 21 out of 92 patients. Of these 21 patients, 13 were fully remission and achieved complete remission through partial hematological rehabilitation. The median duration of these reactions was 3.7 months. Among those who responded to the therapy, the median overall survival was 16.4 months. For non-responders, the median overall survival was 3.5 months. The adverse events reported by the study include anemia, neutropenia and QTC prolongation, an irregular heart rhythm.
Dr. Eunice Wang, director of leukemia services at Roswell Park Comprehensive Cancer Center, and investigators in the pivotal study of Zifomenib said three patients with QTC prolongation were also taking known drugs to cause adverse cardiovascular effects. In addition, electrolyte abnormalities in two of the patients may lead to complications.
“None of the investigators considered these QTC extensions important and did not end treatment due to the extended effects of QTC,” Wang said on a Kura call on Monday night.
Ziftomenib was originally developed by Kura. At the end of last year, Tokyo-based Kyowa Kirin paid $330 million in advance to start a partnership for the drug. Kura will lead the commercialization of the United States, while Kyowa Kirin has the right to commercialize in other parts of the world. Kura’s milestone payments are as high as $1.2 billion. On Sunday, ahead of Ziftomenib ASCO demonstration, Kura and Kyowa Kirin announced that the FDA accepted Ziftomenib’s new drug application and granted priority review on the target date of November 30 for regulatory decisions.
The first inhibitor to enter the market for Menin inhibitors is Revuforj of Syndax Pharmaceuticals, which received FDA approval in November last year. Syndax’s drug introduces mutations in KMT2A, which also relies on Menin. Phase 3 testing of the drug is in progress in NPM1 mutation-driven AML.
The Ziftomenib data provided on ASCO enhances the drug’s welfare risk profile and supports its potential endorsement, Leerink Partners analyst Jonathan Chang wrote in a note sent to investors on Tuesday. He added that the Kura drug may be safer than Syndax’s drug (scientifically known as Revumenib), which has adverse events similar to the critical studies of Ziftumenib, but at a higher speed.
“Overall, Ziftomenib continues to demonstrate comparable efficacy with Repumenib relative to more favorable security,” Chang wrote. “We consider these data as supporting Ziftomenib in [relapsed/refractory] NPM1M AML and enhances its competitive positioning in local Menin inhibitors. ”
The public domain image of the National Cancer Institute
