On November 18, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported data from two scientific posters for its Phase 2 clinical studies of VAL-083, the Company’s lead compound for the treatment of glioblastoma multiforme (GBM) (Press release, Kintara Therapeutics, NOV 18, 2021, View Source [SID1234595798]). The data are being presented at the 26th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) being held in Boston on November 18-21, 2021.
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Kintara is presenting posters on two Phase 2 clinical studies evaluating VAL-083 in patients with MGMT-unmethylated GBM as follows:
Poster CTNI-21: "Phase 2 clinical trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated GBM"
The first poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients conducted at Sun Yat-sen University Cancer Center in China.
For the 25 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, progression free survival (PFS) was 8.7 months (95% confidence interval: CI 6.4-12.5) and median overall survival (mOS) was 19.1 months (CI 12.0-22.3). While not a head-to-head study, this compares favorably to historical temozolomide (TMZ) control ranging from 5.0-6.9 months PFS and 12.7-16.0 months mOS*.
The poster also highlights a case report from the study for a patient who remains progression free for more than 37 months after diagnosis. All patients have completed treatment. Adverse events have been consistent with prior studies with myelosuppression being the most common adverse event.
Poster CTNI-26: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT unmethylated, bevacizumab naïve glioblastoma in the adjuvant or recurrent setting"
The second poster outlined the two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM being conducted at the MD Anderson Cancer Center in Houston.
In the recurrent group, for the 48 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, mOS was 8.0 months (CI 6.6-10.3). While not a head-to-head study, this compares favorably to historical lomustine control mOS of 7.2 months**.
In the adjuvant group, for the 36 efficacy evaluable patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, PFS was 9.5 months (CI 8.2-10.8) and mOS was 16.5 months (CI 13.6-19.3). While not a head-to-head study, this compares favorably to historical TMZ control ranging from 5.0-6.9 months PFS and 12.7-16.0 months mOS*.
All patients have completed treatment. Consistent with prior studies, myelosuppression was the most common adverse event in both recurrent GBM and in the adjuvant setting.
*Hegi et al N Eng J Med (2005); Tanguturi et al. NeuroOncol (2017); Alnahhas et al. Neurooncol Adv (2020)
** Wick et al N.Eng.J.Med (2017)