Clinical Data from Phase 2B Trial -- Data published in Clinical Cancer Research indicate that early determination of PFS with modified RANO criteria may be a strong surrogate for overall survival in recurrent glioblastoma
-- Medicenna’s proposed patient population shows a tumor control rate of 81% (26/32) based on modified RANO criteria
TORONTO and HOUSTON, May 07, 2021 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or “the Company”) (NASDAQ: MDNA TSX: MDNA), a clinical stage immuno-oncology company, today announced the peer-reviewed publication of clinical data from the Company’s Phase 2b recurrent glioblastoma (rGBM) trial in Clinical Cancer Research. The paper , entitled “Modified RANO, Immunotherapy RANO, and Standard RANO Response to Convection-enhanced Delivery of IL4R-targeted Immunotoxin MDNA55 in Recurrent Glioblastoma,” was published in collaboration with researchers at several prestigious institutions including University of California Los Angeles and Duke University.
Fahar Merchant, PhD, President and Chief Executive Officer of Medicenna, commented, “This Phase 2b trial has generated compelling data, and we are very pleased to have them published in such a prestigious peer-reviewed journal. In particular, we are highly encouraged by results showing that early determination of progression free survival (PFS) using modified RANO (mRANO) may be a strong surrogate for overall survival in rGBM. We believe this finding and the positive mRANO PFS and overall survival (OS) data from our proposed patient population bode well for the outcome of the planned Phase 3 trial, which utilizes an innovative open label hybrid design with OS as the primary endpoint. Medicenna is pursuing a partnership strategy to continue the Phase 3 development.”
The Phase 2b trial evaluated MDNA55, an interleukin-4 (IL-4)-guided toxin, as a treatment for rGBM, the most common and uniformly fatal form of brain cancer. Results presented in the peer-reviewed paper show that the median OS of radiographically evaluable patients in the trial irrespective of dose or IL4R expression was 11.8 months, which is longer than what would be expected from the approved drugs carmustine (OS of 5.1 – 7.5 months) 1,2 , lomustine (OS of 7.1 – 9.8 months) 3-5 , or temozolomide (OS of 5.4 – 9.9 months) 3,6,7 . Notably, the data also show a potential link between patients experiencing radiographic progression and those exhibiting insufficient MDNA55 penetration into the tumor, suggesting that at least a portion of patients who did not respond well to MDNA55 may have benefited from higher drug concentrations.
Additional analyses from the publication show that both locally and centrally determined PFS using mRANO criteria strongly correlated with OS, suggesting that the mRANO criteria may be superior to the standard RANO and iRANO at predicting OS, particularly for immunotherapies. These analyses supplement previously presented findings observed in Medicenna’s proposed patient population showing an 81% tumor control rate (26/32) based on mRANO and a median OS of 15.7 months, which represents a >100% improvement compared to an external control arm (median OS of 7.2 months). The proposed patient population included all MDNA55-treated trial participants with high IL4R expression and participants with low IL4R expression that received a high dose of MDNA55 treatment.
Medicenna is currently pursuing a partnership strategy to facilitate MDNA55’s further development through the planned Phase 3 clinical trial. Following an End of Phase 2 meeting with the United States Food and Drug Administration (FDA), the agency agreed that Medicenna could conduct an open label hybrid Phase 3 trial that allows use of a substantial number of subjects (two-thirds) from a matched external control arm to support regulatory approval of MDNA55 for rGBM. The FDA also expressed their willingness to consider an interim analysis of the trial if certain criteria are met. Unlike conventional randomized control trials, the hybrid trial design will reduce the overall number of subjects needed in the study to achieve the primary endpoint as well as reduce the cost and timelines associated with completing the trial.