On November 19, 2020 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported interim data on its two Phase 2 trials of VAL-083, the Company’s lead compound for the treatment of glioblastoma multiforme (GBM) (Press release, Kintara Therapeutics, NOV 19, 2020, View Source [SID1234571433]). The data are to be presented in two posters at the 25th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) which will be held virtually due to the Covid-19 pandemic on November 19-21, 2020.

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"I’m extremely pleased with the continual progress being achieved by both of these ongoing Phase 2 clinical studies evaluating VAL-083, as the results garnered thus far are an indicator of the compound’s potential to be an important therapeutic option for GBM patients in the recurrent, newly-diagnosed first-line, and newly-diagnosed adjuvant treatment settings," commented Saiid Zarrabian, Kintara’s Chief Executive Officer. "It is a pleasure to present the data updates at the Society for Neuro-Oncology’s Annual Meeting, as these studies have provided valuable insight in initiating the VAL-083 arm of the Global Coalition for Adaptive Research GBM AGILE registrational study which is expected to occur later this year."

Dr. John de Groot, professor, Department of Neuro-Oncology at The University of Texas MD Andersen Cancer Center and also a founding member of Kintara’s Scientific Advisory Board stated, "These data continue to confirm VAL-083’s compelling potential as a potent DNA targeting cytotoxic agent for the treatment of GBM. I’m particularly encouraged by VAL-083’s continued ability to demonstrate a favorable progression-free survival trend as compared to TMZ historical data in newly-diagnosed GBM, and improvement in overall survival compared to lomustine historical data in the recurrent setting."

At the SNO Annual Meeting, Kintara is to present posters updating two Phase 2 clinical trials evaluating VAL-083 in patients with MGMT-unmethylated GBM as follows:

Newly-Diagnosed and Recurrent GBM

The first poster outlined interim data from two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at the MD Anderson Cancer Center in Houston.

In newly-diagnosed patients receiving VAL-083 as adjuvant therapy following treatment with radiation and TMZ, for the 27 efficacy evaluable patients (of a planned up to 36 patients) as of the data cut-off of October 23, 2020, median progression-free survival (PFS) is currently 10.0 months (confidence interval: CI 7.6-10.8). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively.

For patients in the recurrent group receiving second-line therapy with VAL-083 following first-line TMZ failure, 84 patients have been enrolled as of the data cut-off of October 23, 2020 with 35 patients (34 efficacy evaluable) having received an initial dose of 40 mg/m2/day and 49 (43 efficacy evaluable) having received the planned Phase 3 initial dose of 30 mg/m2/day (on days 1, 2 and 3 of a 21-day cycle). Median overall survival (mOS) for the 77 efficacy evaluable patients who have completed at least once cycle of treatment was 7.6 months (CI 6.4-10.6 months). Additionally, for the 43 efficacy evaluable patients initially receiving the planned Phase 3 initial dose of 30 mg/m2/day, mOS is currently 8.5 months (CI 6.8-13.7 months). While this is not a head-to-head trial, historically, lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated mOS of 7.2 months***.

Consistent with prior studies, myelosuppression is 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 (the planned dose for the GBM AGILE pivotal study) three subjects have experienced a serious adverse event (SAE) possibly related to VAL-083 in the recurrent group and one patient has experienced a possibly drug-related SAE in the adjuvant group as of the relevant data cut-off dates.

First-Line GBM

The second poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients being conducted at Sun Yat-sen University Cancer Center in China. For the 29 patients who had completed at least their first efficacy assessment as of the October 21, 2020 cut-off date, median PFS with VAL-083 is currently 9.3 months (95% CI 6.4-12.0 months). Additionally, for the 25 patients initially receiving the treatment dose that will be carried forward in the GBM AGILE pivotal Phase 3 study of 30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle, median PFS was reported to be 8.7 months (CI 6.4-12.5 months). While not a head-to-head study, this PFS data compares favorably to historical TMZ control of 5.3 months* and 6.9 months**, respectively. Multiple treatment cycles of VAL-083 at the 30 mg/m2/day dose in combination with standard radiation treatment (2 Gy/day, 5 days/week) was shown to be generally safe and well-tolerated.