Patients in Sellas Life Sciences’ phase 3 study for acute myeloid leukaemia (AML) treatment are living longer than anticipated. This news has been a positive sign and has led to a change in the nature of the study. It remains to be concluded if the medicine alone led to this increase in life.
The data has yet to be unblinded, and the analysis that resulted in the change in the main endpoint was pooled, which means that patients who got the medication were grouped with those in the control arm.
The late-stage REGAL research, which includes patients with AML who have achieved full remission following second-line salvage treatment, is testing Sellas medication (galinpepimut-S). The primary aim is overall survival, which is a measure of how many patients survive the therapy.
The business does know that patients are living “considerably longer” than expected based on their previous beliefs about the normal course of AML. Following discussions with the independent data monitoring committee, Sellas is making a number of adjustments to the study, including increasing the enrolment objective from 116 to a range of 120-140 patients.
Sellas has lowered the number of fatalities planned for the interim analysis from 80 to 60, with the deaths predicted to occur in the next two years from 2022. The final study has reduced the number of deaths from 105 to 80, which Sellas anticipates occurring by the end of 2024. Finally, the statistical significance threshold has been raised to roughly more than a year of overall survival compared to eight months for patients receiving the best available treatment, which is the trial’s primary objective.
The CEO of Sellas Angelos Stergiou stated:
“Although I cannot predict, I do believe and hope for the entire leukemia area that GPS is the driver, but again, until and until we unblind the data, we don’t know, and clearly we’re really thrilled to accomplish that here very soon. If patients would have died earlier, our discussion today would have been different, to the extent that we can and that I can be, I’m very hopeful that GPS is driving the survival benefit.”
As per the CEO, reducing the number of deaths required for examination would allow the research to be completed faster while being sensitive to the medication’s possible effects.
Sellas had found a 16-month difference between individuals getting GPS and those receiving the best available treatment in a prior phase 2 study. Patients who received GPS had a 21-month overall survival compared to 5.4 months in the control arm.
The investigation will take longer than anticipated to reach the completion stage. The investors of the company have reduced the share price by 45% from $2.48 to $2.07./
On the sidelines, Sellas’ Chinese partner business 3D Medicines has joined the research and will recruit around 20 patients from the greater China region. This is due to the extension of the enrollment objective, which implies Sellas is eligible for a milestone payment in the second half of 2023.