Kintara offers peek at mid-stage data in relapsed glioblastoma patients; Jazz wins quick approval for pediatric cancer drug
Among the dozens of cancer types, glioblastoma has proven one of the hardest to crack with little clinical success over the years. Now, a San Diego biotech is rolling out mid-stage data it claims could be pointing its drug in the right direction in relapsed patients. But there are several caveats.
A high dose of Kintara’s VAL-083 spurred a median OS of 8 months in patients with recurrent glioblastoma who had been previously treated with chemotherapy temozolomide, according to topline data from an open-label Phase II study conducted at MD Anderson Cancer Center in Houston.
The recurrent patient arm was one of two in the Phase II test, and Kintara thinks the results show promise. Patients taking lomustine, the chemotherapy most commonly used in those patients, has shown an OS of 7.2 months. The study isn’t a head-to-head, however, and Kintara didn’t disclose whether the early results were statistically significant.
Five patients in the recurrent arm experience serious side effects that were “possibly related to therapy,” Kintara said. — Kyle Blankenship
FDA approves new Jazz cancer drug
Jazz Pharmaceuticals on Wednesday won FDA approval for its new drug Rylaze, which is a component of a multi-agent chemo regimen for the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase.
The approval was based on a multicenter trial in 102 patients with ALL or LBL with hypersensitivity to E. coli-derived asparaginase. FDA said the results of modeling and simulations showed that for a dosage of 25 mg/m2 administered intramuscularly every 48 hours, the proportion of patients maintaining nadir serum asparaginase activity ≥ 0.1 U/mL at 48 hours after a dose of Rylaze was 93.6% (95% CI: 92.6%, 94.6%). The agency approved this application 10 months ahead of its PDUFA date, as part of the Real-Time Oncology Review pilot program.
The FDA also collaborated with Health Canada on the review as part of Project Orbis, an initiative of the FDA Oncology Center of Excellence. — Zachary Brennan