Small-molecule therapy fails to improve efficacy in brain cancer trial
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A small-molecule chemotherapeutic did not improve efficacy compared with standard therapies in adults with glioblastoma, according to the manufacturer.
Preliminary results from the phase 2/phase 3 Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) trial showed no unexpected safety issues associated with the use of VAL-083 (Kintara Therapeutics), an investigational bi-functional DNA-targeting agent previously granted fast track designation by the FDA for patients with newly diagnosed unmethylated glioblastoma.
GBM AGILE is a seamless response-adaptive randomized trial designed to evaluate multiple therapies in newly diagnosed and recurrent glioblastoma. OS served as the trial’s primary outcome measurement.
Topline efficacy results from the study have led Kintara to suspend further development of VAL-083 to focus on other agents in its asset pipeline, according to a company-issued press release.
“Glioblastoma represents a high unmet medical need, and patients with this disease have very few treatment options,” said Robert E. Hoffman, president and CEO of Kintara, said in the release.
"We are very disappointed that the VAL-083 GBM AGILE Study preliminary results do not support continued development efforts to give patients additional treatment options,” Hoffman added. “We sincerely appreciate the exceptional support from patients and their families as well as patient advocates, physicians and our employees who have been committed to the rigorous study of VAL-083.”
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