For Rubraca vs placebo: the HR for PFS was 0.52 (p=0.0004) in the overall ITT population (n=538); and the HR for PFS in the co-primary endpoint of HRD*-positive patients (n=234) was 0.48 (p<0.0001).
Based on these data, CLVS will submit an sNDA and an MAA during 2Q22 and 3Q22, respectively.
The second part of the trial comparing Rubraca + Opdovo to Rubraca monotherapy is not yet mature.
*Homologous-Recombination Deficiency (which includes BRCA mutations).
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”