Daiichi Sankyo has successfully received authorization from the health ministry of Japan for EZHARMIA- a unique inhibitor of EZH1 and EZH2 and is used in the treatment of adult T-cell leukemia/lymphoma patients with relapsed or refractory disease. Both enzymes are often altered or overexpressed in hematologic cancers, including several T-cell lymphomas, and evidence indicates that they can contribute to tumor suppressor gene silence and promote oncogenic development.
Although EZHARMIA has gotten approval in Japan for the treatment of patients with leukemia, it is still a medication in the testing phase in all the other countries. This is an achievement for the company as at the international level, EZHARMIA is the company’s sixth licensed cancer treatment medication in the last 3 years.
Daiichi Sankyo is a Japanese pharmaceutical company; second largest company of its kind in the country. The company has a global presence in over 20 countries and has a current portfolio of medications for cancer and cardiovascular disease.
The phase 2 study conducted in Japan for the drug focused on evaluating the effectiveness of EZHARMIA taken at a dosage of 200 mg daily on patients with relapsed ATL with 25 participants. The findings were then presented at the American Society of Hematology (ASH) Annual Meeting in 2021.
Adult T-cell leukemia or lymphoma (ATL) is a severe form of hematologic cancer caused by the human T-cell lymphotropic virus type (HTLV-1). ATL is more common in areas where the HTLV-1 virus is prevalent, such as:
· Central, and South America
· Southwest Japan
Each year, around 3,000 new cases of ATL are identified worldwide. ATL has caused nearly 1,000 new cases and 1,000 fatalities in Japan and has a five-year overall survival rate of about 14%.
The MHLW approved EZHARMIA based on the findings of a phase 2 research in Japan that evaluated effectiveness and safety in 25 patients with three aggressive subtypes of relapsed ATL. An independent effectiveness evaluation committee determined that the trial had an objective response rate (ORR) of 48%. The percentage of complete responses in patients was 20% whereas the share of the partial response was close to 28%. The most prevalent drug-related adverse events led to the following figures being reduced:
· Alopecia (40%)
· Dysgeusia (36%)
· Anemia (44%)
· Lymphocyte count (20%)
· Platelet count (80%)
· Neutrophil count (20%)
· White blood cell count (20%)
Wataru Takashi, Head of Research and Development at Daiichi stated:
“EZHARMIA is considered an essential improvement in treating patients with relapsed or refractory leukemia who had very few options left other than intense chemotherapy. We are pleased to have effectively turned the science underlying dual EZH1 and EZH2 inhibition into a new and unique therapy for these patients, who have a dismal prognosis and represent one of Japan’s most critical unmet medical needs.”