Kintara Therapeutics, Inc. (Nasdaq: KTRA) (“Kintara” or the “Company”), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or resistant to, current treatment regimens, today announced interim data results from two Phase 2 clinical trials evaluating VAL-083, the Company’s lead compound, for the treatment of glioblastoma multiforme (GBM)
| SAN DIEGO, April 12, 2021 /PRNewswire/ -- Kintara Therapeutics, Inc. (Nasdaq: KTRA) (“Kintara” or the “Company”), a biopharmaceutical company developing novel cancer therapies for patients who are failing, or resistant to, current treatment regimens, today announced interim data results from two Phase 2 clinical trials evaluating VAL-083, the Company’s lead compound, for the treatment of glioblastoma multiforme (GBM). The data were presented in two posters at the 2021 American Association for Cancer Research (AACR) Annual Meeting, which is taking place virtually from April 10-15, 2021. Poster CT238 provides an update from two patient groups receiving VAL-083 in an open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings being conducted at the MD Anderson Cancer Center in Houston, Texas. The second poster, CT172, updates 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. “These interim data updates at the AACR Annual Meeting continue to demonstrate VAL-083’s potential as a game-changing treatment option for GBM patients,” commented Saiid Zarrabian, Kintara’s Chief Executive Officer. “Furthermore, it’s important to note that both trials have provided valuable insights as we prepared to initiate the VAL-083 arm of the Global Coalition for Adaptive Research GBM AGILE registrational study which commenced patient enrollment in February 2021.” Poster CT238: “Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the adjuvant or recurrent setting” In newly-diagnosed patients receiving VAL-083 as adjuvant therapy following treatment with radiation and temozolomide (TMZ), for the 33 efficacy evaluable patients (of a planned 36 patients) as of the data cut-off of March 12, 2021, median progression-free survival (PFS) is currently 10.0 months (95% confidence interval: CI 8.2-10.8). 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 fully enrolled recurrent group receiving second-line therapy with VAL-083 following first-line TMZ failure, 89 patients have been enrolled as of the data cut-off of March 12, 2021 with 35 patients (35 efficacy evaluable) initially receiving a dose of 40 mg/m2/day and 54 (48 efficacy evaluable) initially receiving the treatment dose that is being carried forward in the GBM AGILE study of 30 mg/ m2/day on days 1, 2 and 3 of a 21-day cycle. Median overall survival (mOS) for the 83 efficacy evaluable patients who have completed at least once cycle of treatment was 7.5 months (CI 6.0-9.0 months). Additionally, for the 48 efficacy evaluable patients initially receiving a dose of 30 mg/ m2/day, mOS is currently 7.9 months (CI 5.9-9.9 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 settings. In the 30 mg/m2/day starting dose cohort (the dose that is being carried forward in the GBM AGILE study) seven 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. Poster CT172: “Phase 2 clinical trial of dianhydrogalactitol (VAL-083) in patients with newly-diagnosed MGMT-unmethylated GBM” In the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients, median PFS for the 29 patients, as of the March 11, 2021 cut-off date, is currently 9.3 months (CI 6.4-12.0 months). Additionally, for the 25 patients initially receiving the treatment dose that is being carried forward in the GBM AGILE 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. Three subjects have experienced an SAE possibly related to VAL-083. 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) were shown to be generally safe and well-tolerated. This study has been fully enrolled, and all patients have completed treatment with VAL-083 and are currently in follow-up. *Hegi et al N Eng J Med 352; 997-1003 (2005) About Kintara VAL-083 is a “first-in-class”, small-molecule chemotherapeutic with a novel mechanism of action that has demonstrated clinical activity against a range of cancers, including central nervous system, ovarian and other solid tumors (e.g., NSCLC, bladder cancer, head and neck) in U.S. clinical trials sponsored by the National Cancer Institute (NCI). Based on Kintara’s internal research programs and these prior NCI-sponsored clinical studies, Kintara is currently conducting clinical trials to support the development and commercialization of VAL-083 in GBM. REM-001 is a proprietary, late-stage photodynamic therapy platform that holds promise as a localized cutaneous, or visceral, tumor treatment as well as in other potential indications. REM-001 therapy has been previously studied in four Phase 2/3 clinical trials in patients with CMBC who had previously received chemotherapy and/or failed radiation therapy. With clinical efficacy of 80% complete responses of CMBC evaluable lesions and an existing robust safety database of approximately 1,100 patients across multiple indications, Kintara is advancing the REM-001 CMBC program to late-stage pivotal testing. For more information, please visit www.kintara.com or follow us on Twitter at @Kintara_Thera, Facebook and Linkedin. Safe Harbor Statement CONTACTS Media
SOURCE Kintara Therapeutics | ||
Company Codes: NASDAQ-NMS:KTRA |
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