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Good news from the Phase 1 ReSPECT-LM trial evaluating an investigational radiotherapeutic (REYOBIQ™) in patients with leptomeningeal metastases (LM) - a rare, aggressive complication in advanced cancers. Among 29 patients treated in escalating dose cohorts, there was a 76% radiographic response rate and 87% clinical response rate. A strong biological effect was also observed; patients had up to 100% reduction in tumor cells found in the cerebrospinal fluid, and five of seven patients with major tumor cell reductions survived at least one year, which is well above the typical 2-6 month median survival for LM.
Across the first four dosing cohorts (20 patients),median survival was 9 months, which is an improvement over historical outcomes. Side effects were mostly mild (grade 1–2), and only two patients experienced serious dose-limiting toxicity (grade 4 cytopenia) at the highest dose levels. Based on this trial, the team has identified a recommended dose for a Phase 2 trial. These early results suggest REYOBIQ has the potential to become a much-needed targeted treatment option for LM.