The Connexion Healthcare Oncology Center of Excellence is excited about a novel approach to treating acute myeloid leukemia (AML) for patients who express a specific biomarker and whose disease is refractory to other treatments. Promising data from a study of patients with advanced hematologic malignancies treated with Agios Pharmaceuticals’ experimental drug AG-221 were presented at the 20th Congress of the European Hematology Association, held in Vienna from June 11 to 14, 2015.
In this study, 177 patients were treated with AG-221, a first-in-class novel oral agent and IDH2 inhibitor. This phase 1 clinical trial consisted of a dose-escalation phase and an expansion phase. For the 158 patients who were considered response-evaluable, an overall response rate of 41% and a complete remission rate of 18% were seen among those with relapsed or refractory AML. Results were similarly impressive for patients with previously untreated AML, who experienced an overall response rate of 32% and a complete remission rate of 14%. AG-221 was also shown to have durable clinical activity, with patients receiving the treatment for more than 15 months and with 76% of responses lasting longer than 6 months. For this high-risk patient population, such results are highly encouraging: according to study investigator Eytan Stein, response rates for patients with advanced AML are typically lower than 10%. He went on to add that “the duration of response is, to some extent, unheard of.”
Recruitment for this trial continues, with an additional study arm for the expansion cohort planned that will enroll patients with IDH2 mutation–positive AML who are in second or later relapse, who are refractory to second-line induction or reinduction treatment, or who have relapsed after allogeneic transplantation. IDH2 mutations, which are present in up to 13% of AML cases, lead to increased levels of a metabolic biomarker that can be monitored in patients’ plasma. In this study, treatment with AG-221 reduced the level of the biomarker to that seen in healthy volunteers. In the second half of 2015, Agios will initiate a phase 3 global trial in patients with the IDH2 mutation and relapsed or refactory AML.
About the Connexion Healthcare Oncology Center of Excellence
Connexion Healthcare’s Oncology Center of Excellence offers executive talent with decades of experience in the pharmaceutical industry. Our medical directors have conducted oncology research at leading institutions and major pharmaceutical companies. Our account leads have years of project execution expertise, and our medical editors are versed in the language of oncology. Our design leads are tops in their fields and ensure that your objectives are met effectively and even surpassed in an industry-eloquent and compliant manner. Our team works with you to conceive a strategy and execute communications through your product’s lifespan – from drug discovery through market launch and beyond. With particular expertise in phase 2 through postlaunch, we will engage with you wherever you are in development and whenever you need us.
For further information regarding the Oncology Center of Excellence at Connexion Healthcare and how we can develop oncology communications to differentiate therapies by their unique attributes, contact:
Larry Lunak, Senior Vice President
Valery Sudakin, PhD
Hematology/Oncology Scientific Services