Memgen announced today that positive data evaluating its active cellular immunotherapy product, ISF35, in combination with chemotherapy in resistant chronic lymphocytic leukemia (CLL) were presented December 7 during the 51st Annual Meeting of the American Society of Hematology (Abstract #376). The ongoing phase Ib trial’s first two patients have both achieved minimal residual disease-negative (MRD-) complete responses, according to Januario Castro, M.D., Associate Clinical Professor, Bone Marrow Transplant Division of the University of California, San Diego (UCSD).
The study, which is co-sponsored by the Leukemia & Lymphoma Society, evaluated three infusions of patients’ CLL cells exposed outside the body to ISF35 followed by standard chemo-immunotherapy (fludarabine, cyclophosphamide, and Rituxan®, also known as FCR).
Both patients had high-risk CLL with 17p deletion, which is associated with short survival and resistance to treatment. By comparison, less than 11% of patients with this condition achieve a complete response to FCR chemotherapy without ISF35, according to the presentation.
“These are very encouraging results, especially in the setting of patients with high risk CLL,” said Dr. Castro. “If our preliminary results are confirmed, this new therapy could be a breakthrough for patients with refractory and 17p-deleted CLL.”
The ISF35 plus FCR regimen has been well-tolerated so far. Patients have experienced mild flu-like symptoms after receiving ISF35-modified cells, and have encountered expected side effects with the chemotherapy.