SLS will File a BLA for AML CR1 Patients at the Same time as the CR2 Filing
- 10,000 AML CR2 Patients will be eligible for GPs Immunotherapy each year - per the company Deck August 2025.
- GPS P3 being conducted for AML CR2 patients, AML patients in Second Remission who are NOT Transplant Eligible
- An expanded Biologic Label Application for Primary Remission Patients 16,500 per year, will be included with the Cr2 Filing.
Very Simple Logic: if there is a Cr2 BLA Filing, it means GPs has Demonstrated Superior Efficacy, and Increased Overall Survival, which given the homogenous nature of the CR1 and Cr2 patients means It will also be Effective in CR1.
As Importantly, Memorial Sloan Kettering Conducted a Phase 2 Trial for AML Cr1 patients, which achieved exceptional results
- a MOS of 67.7 which is better than Stem Cell Transplant.
Additionally, 18 months deep into the phase 3 trial, clinical investigators, the actual dr's treating the P3 patients, including Dr. Kantarjian, Chair of MD Anderson's Leukemia dept., the Global trial lead, requested Expanded Access to Gps for other AML Patients, including AML Cr1 patients.
Dr. Kantarjian, MDACC posted an internal Newsletter at the time* relaying this news.
It is very telling the Dr's treating actual patients would request Expanded Access, and the co did Begin an official EAP the second quarter of 2022.
2018 Discussion Regarding Modifying Phase 3 From CR1 to Cr2
Posted Aug 8, 2025, 9:09 PM UTC