Kintara Therapeutics Inc (NASDAQ:KTRA) announced Wednesday that it has enrolled the final patient in the recurrent arm of its ongoing Phase 2 clinical glioblastoma multiforme (GBM) study of its VAL-083 drug.
The recurrent arm of the study addresses patients suffering from GBM who have been pre-treated with the drug temozolomide (TMZ) prior to disease recurrence, the company said. The trial is designed to treat up to 83 patients (35 patients at 40 milligrams per square meter per day and 48 patients at 30 mg/m2/day) to determine whether treatment with VAL-083 improves overall survival.
GBM is the most deadly form of brain cancer, and this trial could shorten VAL-083 timeline to pivotal trial completion and potential regulatory submission by as much as 18 months. The study is being conducted at the MD Anderson Cancer Center.
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"Given the urgent need for improved treatment options for this deadly disease, we are pleased to have reached the very important milestone of full enrollment in the recurrent arm of this Phase 2 clinical study," CEO Saiid Zarrabian said in a statement.
"We would like to thank our patients, their families, and MD Anderson for their participation and continued support for this arm of the trial and of course, for our adjuvant study arm as well. Moving forward, we anticipate reporting topline results from the recurrent arm in the second quarter of calendar 2021."
The Phase 2 trial is an open-label, two-arm, biomarker-driven study testing VAL-083 in GBM patients who have an unmethylated promoter of the methylguanine DNA-methyltransferase (MGMT) gene, the company said. In addition to the recurrent arm, there is a second trial arm that is enrolling up to 36 newly diagnosed patients who have undergone surgery and chemoradiation with TMZ, and who are receiving VAL-083 in place of standard of care TMZ for adjuvant therapy.
In November, Kintara provided an update on both arms of the study. In the recurrent arm, median overall survival (mOS) for 77 patients who completed at least one cycle of treatment was 7.6 months. In the adjuvant therapy arm, median progression-free survival (PFS) was 10 months.
Consistent with prior studies, myelosuppression was the most common adverse event with VAL-083 in both the recurrent GBM and adjuvant treatment setting. In the 30 mg/m2/day starting dose cohort, three subjects experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient experienced a possibly drug-related SAE in the adjuvant group.
Additionally, for 43 patients initially receiving the 30 mg/m2/day dose that is being evaluated in the Global Coalition for Adaptive Research (GCAR) GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) registrational study, mOS was 8.5 months
VAL-083 is a small molecule bifunctional alkylating agent that crosses the blood-brain barrier. The drug has been granted Orphan Drug Designation for GBM by the Food and Drug Administration (FDA) and European Medicines Agency (EMA), in addition to FDA Fast Track Designation in recurrent GBM.
Additionally, VAL-083 has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA and is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer.
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