Orbus Therapeutics’ lead therapy eflornithine has failed to achieve the primary endpoint in the Phase III STELLAR trial, evaluating it as a combination treatment with chemotherapy, lomustine, in patients with recurrent isocitrate dehydrogenase (IDH) mutant astrocytoma.
The company was quick to note that while the STELLAR study (NCT02796261) missed its primary efficacy endpoint of overall survival (OS), the combination therapy achieved “clinically meaningful” improvements in OS and progression-free survival (PFS) compared to lomustine as a single agent.
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The Phase III trial enrolled 343 patients with recurrent IDH mutant astrocytoma, a brain cancer which has recurred following radiation and adjuvant temozolomide chemotherapy, including 194 patients with grade 3 IDH mutant astrocytoma. The combination therapy arm achieved a median OS of 34.9 months compared to 23.5 months seen in the lomustine monotherapy group.
A median PFS of 15.8 months was seen in the combination group, compared to 7.2 months achieved by the lomustine monotherapy arm. Orbus noted that the combination therapy was well-tolerated and no unexpected safety signals were seen in the trial. The commonly observed grade 3+ adverse events were associated with myelosuppression and hearing impairment.
Orbus presented the results from the STELLAR trial at the 29th Annual Meeting and Education Day of the Society for Neuro-Oncology that took place from 21 to 24 November in Houston, Texas.
Eflornithine irreversibly blocks ornithine decarboxylase (ODC), a key enzyme involved in cell division and proliferation associated with various types of cancer. It received orphan drug and breakthrough designations from the US Food and Drug Administration (FDA) as a treatment for anaplastic glioma, an umbrella term for IDH mutant astrocytoma, oligodendroglioma and glioblastoma.
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By GlobalDataThis is not the first time eflornithine has been evaluated in brain cancer indications. Last year, the FDA approved the therapy to reduce the risk of relapse in adult and paediatric patients with high-risk neuroblastoma (HRNB) where it is marketed by US WorldMeds as Iwilfin.
In January, Orbus signed an exclusive licence agreement with Michigan State University (MSU) and Helen DeVos Children’s Hospital (HDVCH) for using eflornithine in the treatment of Bachmann-Bupp Syndrome (BABS), a rare genetic paediatric neurodevelopmental disorder.
