Medicenna Presents Late Breaking Abstract Updating Results from Phase 2b Recurrent GBM Trial at the 36th EORTC-NCI-AACR Meeting
-- Amongst an all-comer population, a single treatment with MDNA55 resulted in at least 100% increase in both 12 month progression free survival (PFS-12 of 27% versus 2 to 10%) and 2-year survival (OS-24 of 20% vs 5 to10%) when compared to what is achieved with approved therapies
-- In a subset of all-comer patients treated with transient low dose bevacizumab, to reduce steroid use, median survival (mOS) was 21.8 months and OS-24 was 44%
The poster presentation updated long-term survival results from the Phase 2b trial evaluating MDNA55, an interleukin-4 (IL-4)-guided toxin, as a treatment for rGBM, the most common and uniformly fatal form of brain cancer. The new results indicate the potential benefit of including transient low dose Avastin® treatment with MDNA55. Enrolled patients had limited treatment options and poor prognostic factors such as non-resectable tumors at first or second relapse, de-novo GBM at initial diagnosis and lack of IDH1/2 mutations.
Highlights from the poster include updated results following a longer follow-up duration and new data based on transient low-dose use of bevacizumab:
- Data from all trial participants show that a single MDNA55 treatment led to a mOS of 11.9 months (expected 6-9 months) which is comparable to earlier reported mOS of 11.6 months, an OS-24 of 20% (expected 0-10%), and a PFS-12 of 27% (expected 2-10%).
- In Medicenna’s proposed patient population, mOS was 14.0 months (comparable to mOS of 15 months reported earlier), OS-24 was 20%, and PFS-12 was 24%. 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.
- Unmethylated MGMT promoter affects more than 50% of GBM patients and is associated with treatment resistance and poorer survival outcomes. However, MGMT status did not negatively affect MDNA55 treatment. In the proposed population (
N=17), mOS was 14.9 months with an OS-24 of 22%.
- Following MDNA55 treatment, transient (median of 3 cycles) low dose (5 mg/Kg q2w or 7.5 mg/Kg q3w) administration of Avastin®, used for symptom control and steroid sparring in patients receiving high concentrations of MDNA55, further improved patient survival. Amongst all comers (N=9) and the proposed population (N=8), mOS was 21.8 months and 18.6 months and OS-24 was of 44% and 38%, respectively.
The electronic ENA poster, titled “MDNA55, a Locally Administered IL4 Guided Toxin for Targeted Treatment of Recurrent Glioblastoma Shows Long Term Survival Benefit”, was presented by Dr.
Medicenna is a clinical stage immunotherapy company focused on the development of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Superkines for the treatment of a broad range of cancers. Medicenna's long-acting IL2 Superkine asset, MDNA11, is a next-generation IL-2 with superior CD122 binding without CD25 affinity and therefore preferentially stimulating cancer killing effector T cells and NK cells when compared to competing IL-2 programs. It is anticipated that MDNA11 will be ready for the clinic in 2021. Medicenna's lead IL4 Empowered Superkine, MDNA55, has completed a Phase 2b clinical trial for rGBM, the most common and uniformly fatal form of brain cancer. MDNA55 has been studied in five clinical trials involving 132 subjects, including 112 adults with rGBM. MDNA55 has obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA, respectively. For more information, please visit www.medicenna.com.
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Source: Medicenna Therapeutics Corp.