SELLAS Life Sciences Group, Inc. (SLS), a late-stage clinical biopharmaceutical company focused on cancer, announced Tuesday positive topline data from the Phase 2a study of SLS009 in relapsed or refractory acute myeloid leukemia or r/r AML.
In the selected optimal dose regimen of 30 mg BIW a 50% response rate was achieved, far surpassing the targeted 20% rate. Meanwhile, median OS has not been reached in the Phase 2a Study.
Further, the company provided an update on Phase 3 REGAL Study of GPS in AML, noting completion of the enrollment.
The Steering Committee has reviewed the study as of the March 1, 2024, cutoff date. As of this evaluation, 123 patients were enrolled with 66 of them discontinuing the treatment.
In the trial, patients are recorded as having stopped the study treatment in cases of death for any reason, relapse, intolerable toxicity, or treatment completion.
Angelos Stergiou, President and Chief Executive Officer of SELLAS, said, "Regarding the GPS arm, we are pleased to report that we have not observed any intolerable toxicities in any patient population across all our clinical studies thus far, although toxicities are commonly observed with therapies used in the control arm. … As the study sponsors, we lack specific information on the outcomes of these 66 patients, hindering our ability to confirm whether the required number of events for interim analysis - 60 - has been reached."
Stergiou noted that the determination of such outcomes, the primary endpoint of the trial, lies within the purview of the IDMC, which is now scheduled to meet by the end of April.
The company said the REGAL Steering Committee met on March 22 to discuss the study and believes the high number of patients who completed participation in the study signals that the interim analysis requiring 60 events may be imminent.
In pre-market activity on Nasdaq, SELLAS shares were gaining around 3.8 percent to trade at $1.08.
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