Kintara Therapeutics (NASDAQ:KTRA) Inc., a biopharmaceutical company focused on the development of new solid tumor cancer therapies, has revealed 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), a lethal brain cancer and other solid tumors.
The data is being presented at the two-day 26th annual scientific meeting of the Society for Neuro-Oncology (SNO) starting on November 18, 2021, in Boston.
The San Diego, California-based clinical-stage drug development company is presenting posters on two Phase 2 clinical studies evaluating Kintara’s VAL-083, a small molecule chemotherapeutic agent for the treatment of patients with MGMT-unmethylated GBM.
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The first poster, CTNI-21, is titled "Phase 2 clinical trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated GBM." It outlines 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.
Kintara revealed that for the 25 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 and median overall survival (mOS) was 19.1 months.
“While not a head-to-head study, this compares favorably to historical temozolomide (TMZ) control ranging from 5-to-6.9 months PFS and 12.7-to-16.0 months mOS,” said the company in a statement.
Significantly, 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,” said the company.
The second poster, CTNI-26, 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 patients enrolled with a starting dose of 30 mg/m2/day x 3 days every 21 days, mOS was 8.0 months. While not a head-to-head study, this compares favorably to historical lomustine control mOS of 7.2 months, noted the company.
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 and mOS was 16.5 months. “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,” said the company.
All the patients have completed the treatment. Consistent with prior studies, myelosuppression was the most common adverse event in both recurrent GBM and in the adjuvant setting, said the company.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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