Imugene managing director and CEO Leslie Chong talked with Proactive about the US Food and Drug Administration (FDA) granting Fast Track Designation to the company's allogeneic CAR T therapy, azer-cel, for relapsed or refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory marginal zone lymphoma (MZL).
Chong explained that Imugene has been advancing azer-cel across several blood cancer indications, with encouraging clinical results reported in heavily pre-treated patients. In CLL, patients had previously failed at least three lines of therapy before receiving azer-cel, while MZL patients demonstrated strong response rates. The company highlighted that responses ranged from partial responses to complete responses, including cases where patients progressed from a partial response to a complete response over time.
The discussion followed Imugene's recent presentation at the American Society of Clinical Oncology (ASCO) conference, where the company presented data from its azer-cel program. Chong said the reception to the data was highly positive and noted the significance of being able to present the results in an oral session.
She also outlined the next steps for the company, including continued patient enrolment, ongoing clinical development and further discussions with regulators, pharmaceutical companies and investors as additional data emerge.
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