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SLS009 exhibits favorable data in R/R lymphomas: topline results from phase I dose escalation trial.
Topline results obtained from a phase I dose escalation trial (NCT04588922) show that primary and secondary endpoints in safety, clinical activity, pharmacokinetics, and pharmacodynamics were met in patients with relapsed/refractory (R/R) lymphomas.1 These results indicate that SLS009 (formerly GFH009) may be a safe and efficacious treatment option for this patient population.1
Key findings1
A total of 52 R/R patients with lymphoma were enrolled and 34 patients were evaluable for efficacy. In this population:
- In total, 14.7% achieved a clinical response, with a reduction in tumor burden of up to 62%.
- Seven patients (20.6%) achieved stable disease, leading to an overall disease control rate of 35.3%.
- Among the patients who had peripheral T-cell lymphoma, four out of 11 patients (36.4%) achieved clinical response.
No patients had unexpected toxicities and the drug was well tolerated, with no drug-related deaths reported at any dose level.
- Patients receiving once-weekly infusions had ≥Grade 3 treatment-related adverse events which occurred at higher dose regimens.
- Non-hematologic toxicities occurred in five patients (9.6%), of whom 5.8% experienced hypokalemia, 1.9% experienced upper respiratory tract infection, and 1.9% experienced increase in bilirubin.
- Maximum tolerated dose was not reached.
The topline data from this phase I dose-escalation trial have led to a phase II clinical study. This study will assess SLS009 in patients with peripheral T-cell lymphoma, further elucidating the potential of this treatment for those with hematologic malignancies who have exhausted previous treatment options.1
References
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