Dr. Fahar Merchant reports
MEDICENNA REPORTS SIGNIFICANT SURVIVAL BENEFIT IN PATIENTS WITH RECURRENT GLIOBLASTOMA FOLLOWING TREATMENT WITH BIZAXOFUSP WHEN COMPARED TO A MATCHED EXTERNAL CONTROL ARM AT THE 2024 ASCO ANNUAL MEETING
Medicenna Therapeutics Corp. presented updated clinical results highlighting significant survival benefit versus a propensity score balanced EC (external control) arm, in the phase 2b study of bizaxofusp (also known as MDNA55; an empowered superkine targeting the IL-4R (IL-4 receptor)) in unresectable rGBM (recurrent glioblastoma) at the 2024 annual meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, Ill., on June 1, 2024.
"Bizaxofusp represents a promising novel approach for targeted delivery of a potent therapeutic payload in rGBM, a uniformly fatal form of brain cancer that does not have an approved standard of care," said Dr. Fahar Merchant, president and chief executive officer of Medicenna. "These updated phase 2b analysis reflect the planned design of a phase 3 registration trial, where patients with unresectable rGBM will be treated with bizaxofusp at the high dose, irrespective of IL-4R expression. These updated data are based on a larger pool of patients when compared to our earlier results, and show, for the first time, that the improvement in survival in the bizaxofusp arm was statistically significant when compared to a well-balanced EC arm. We are encouraged by these findings as we pursue partnership opportunities, plan to seek breakthrough therapy designation and secure alignment with the EMA [European Medicines Agency] for the phase 3 trial design."
Significant survival benefit versus propensity score balanced EC arm irrespective of IL-4R expression
The multicentre, open-label, single-arm, phase 2b study of bizaxofusp enrolled and treated 44 evaluable patients with rGBM following surgery or radiotherapy, plus or minus adjuvant therapy or other experimental therapies. A separate study collected rGBM data from 81 unresectable rGBM patients who had contemporaneously received treatment with other therapies at major clinical centres and was used to establish a matched EC arm. The blinded survival data from the propensity score balanced EC arm (established by matching bizaxofusp-treated population based on 11 different prognostic factors, including IL-4R expression levels as a prognostic factor) were then used as a control arm versus survival data from the phase 2b bizaxofusp trial, as reported previously.
The updated analysis, presented at ASCO 2024, builds upon the prior phase 2b data by excluding IL-4R expression as a prognostic factor in propensity score balancing, thereby increasing the number of bizaxofusp and EC arm patients eligible for analysis. Earlier studies had excluded these patients due to lack of tumour tissue available for IL-4R expression analysis. These expanded data demonstrate that a single treatment of bizaxofusp significantly increased mOS (median overall survival) by 88 per cent (13.5 versus 7.2 months, p equals 0.009), reduced risk of death by approximately half (HR: 0.54, 95 per cent confidence interval: 0.34 to 0.83), and improved OS by 180 per cent at year 1 and 290 per cent at year 2.
These findings imply that bizaxofusp provides a significant survival benefit irrespective of IL-4R expression, thereby negating the need for a companion diagnostic in a commercial setting and broadening the availability of patient data for the EC arm planned for the phase 3 trial.
Tumour control as a surrogate for improved mOS
The analysis presented at ASCO 2024 also demonstrates that patients who showed tumour control, as assessed by mRANO/RANO 2.0, following a single treatment with bizaxofusp had significantly longer mOS when compared with patients with no tumour control (16.7 versus 8.5 months, p equals 0.017). These findings are of importance as prior therapies developed for rGBM have not been able to establish a correlation between tumour control and survival outcomes. These results show that tumour control following bizaxofusp treatment could provide early evidence of survival benefit in future studies.
A copy of the poster and a related slide deck have been posted to the scientific presentations page of Medicenna's website.
About Bizaxofusp
Bizaxofusp (formerly known as MDNA55) is Medicenna's IL-4 empowered superkine that has been studied in five clinical trials in over 130 patients, including a phase 2b trial in patients with recurrent glioblastoma (rGBM), the most common and uniformly fatal form of brain cancer. Results from the phase 2b study, which were published in the journal Neuro-Oncology (Sampson et al., June, 2023), demonstrated that bizaxofusp more than doubled the median survival in end-stage rGBM patients when compared with a well-matched external control arm. Medicenna has obtained agreement from the United States FDA (Food and Drug Administration) on the study design for the registrational phase 3 Light (localized infusion for the treatment of recurrent glioblastoma with high-dose bizaxofusp therapy) trial, and the company is actively pursuing potential partnerships to conduct the Light trial, and, if approved, bizaxofusp's commercialization in key global markets. Bizaxofusp has been granted fast-track and orphan drug statuses from the FDA and FDA/EMA, respectively.
About Medicenna
Therapeutics Corp.
Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 superkines and first-in-class empowered superkines. Medicenna's long-acting IL-2 superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T-cells and NK cells. Medicenna's IL-4 empowered superkine, bizaxofusp (formerly MDNA55), has been studied in five clinical trials enrolling over 130 patients, including a phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained fast-track and orphan drug status from the Food and Drug Administration and FDA/European Medicines Agency, respectively. Medicenna's early-stage BiSKITs (bifunctional superkine immunotherapies) and the T-MASK (targeted metalloprotease activated superkine) programs are designed to enhance the ability of superkines to treat immunologically cold tumours.
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