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DewDiligence

03/31/22 9:11 AM

#241842 RE: crudeoil24 #237486

CLVS +43%/PM on phase-3 Rubraca-monotherapy data in first-line maintenance setting in ovarian cancer:

https://finance.yahoo.com/news/clovis-oncology-rubraca-rucaparib-significantly-100000716.html

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).