8/103 sources · 3 publishersUpdated Oct 28, 13:07 UTC
SELLAS Life Sciences reaches 80th death in Phase 3 AML trial, triggering final analysis
SELLAS Life Sciences Group announced that its pivotal Phase 3 REGAL trial of galinpepimut‑S in acute myeloid leukemia patients has reached the pre‑specified 80th death, the event that triggers the study’s final analysis. The company will lock the database, unblind the data and conduct statistical analysis of the primary overall‑survival endpoint. Preliminary topline results are slated for release later this quarter.
Why it matters
The company said it expects to report preliminary results this quarter, which removes timing uncertainty for the trial’s outcome and could move the stock as investors await efficacy data.
Key facts
- 1The REGAL trial reached the pre‑specified 80th event (deaths), triggering the final analysis. stocktitan.net
- 2SELLAS will proceed with database lock, unblinding and statistical analysis of the primary endpoint. stocktitan.net
- 3Preliminary topline primary‑endpoint results are expected to be announced this quarter. stocktitan.net
- 4The trial evaluates galinpepimut‑S as a maintenance therapy in AML patients who have achieved a second complete remission. investing.com
- 5SELLAS is also developing SLS009, a CDK9 inhibitor for AML. stocktitan.net
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.