AK117 phase 1b
https://ashpublications.org/blood/article/142/Supplement%201/1865/504435/AK117-anti-CD47-monoclonal-antibody-in-Combination
"As of June 21, 2023, among 27 evaluable patients, the CR rate was 48.1%. 8 patients achieved marrow CR (5 also with hematologic improvement [HI]), and 2 patients achieved HI alone. Among 24 evaluable patients with ≥ 3 months follow-up, the CR rate further escalated to 54.2%
The primary endpoints of this study were safety/tolerability and the complete remission (CR) rate based on the International Working Group (IWG) 2006 response criteria."
https://akesobio.com/en/media/akeso-news/231214/
"Among 27 evaluable patients, the complete remission (CR) rate was 48.1% and the overall response rate (ORR) was 85.2%. When patients received≥3 cycles of treatment, the CR rate reached 52%; when patients received≥6 cycles of treatment, the CR rate reached 68.4%
Akeso is consistently advancing the development of AK117 as a therapeutic agent in combination with various agents such as PD-1/CTLA-4 and PD-1/VEGF, for the treatment of multiple hematologic malignancies and solid tumors."
Jos tekee satunnaistetun faasi 2:n jossa potilasmäärä kuitenkin alle 100 niin mahtaako se vaikuttaa siihen juuri mitenkään mitä FDA vaatii f3 potilasmääräksi?