Concerns over Leclaza's sluggish secondary indicators
By | translator Choi HeeYoung
22.12.05 14:39:57
PFS over 20 months
proves its superior effectiveness in Real World
Yuhan Corporation's new anti-cancer drug Leclaza is expected to not significantly improve the overall survival period (OS), which is a secondary indicator, in the global phase 3 (LASER301) clinical trial
This is in contrast to the significant improvement in the primary indicator, the progression-free survival period (PFS). We cannot rule out the possibility that a similar situation to Tagrisso, whose effectiveness was questioned by the Asian OS, will be reproduced. The global clinical director (PI) explains that it is not easy to secure statistical significance due to the relatively high ratio of crossover converted to third-generation treatments due to confirmed resistance mutations among control patients. Cho Byung-chul, a professor of oncology at Yonsei Severance Hospital, who oversees LASER301 clinical trials, said at a press conference held in Singapore on the 3rd (local time), "Leclaza failed to meet the statist
(same@dailypharm.com)