SELLAS Life Sciences Reports Positive Topline Data In Lymphoma Cohort From SLS009 Phase 1 Trial
(RTTNews) - SELLAS Life Sciences Group, Inc. (SLS) announced Thursday positive topline data for the patient group with relapsed/refractory (r/r) lymphomas from the Phase 1 dose-escalation trial of its CDK9 inhibitor, SLS009 (GFH009).
The trial successfully achieved all primary and secondary study objectives, including safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD).
The recommended Phase 2 Dose (RP2D) for lymphoma patients has been established at the highest dose level evaluated of 100 mg, administered as a once-weekly infusion. The maximum tolerated dose (MTD) was not reached.
A dose-limiting toxicity occurred in one out of five patients treated at the 100 mg dose level. No dose-limiting toxicities were observed at any other dose level, and there were no unexpected toxicities across the study.
A total of 52 r/r lymphoma patients were enrolled. Of these, 24 received two bi-weekly doses (BIW), while 28 were administered weekly doses (QW). Among the 52 r/r lymphoma patients, 15 were diagnosed with PTCL, with 6 of them receiving the BIW regimen and 9 the QW regimen.
The dose-escalation trial investigated a range of doses from 2.5 mg to 100 mg, employing two dosing regiments: once-weekly infusions (QW) and twice-weekly infusions (BIW).
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