Clovis Oncology Announces European Commission Authorization Of Rubraca (Rucaparib) Tablets As Maintenance Treatment For Women With Relapsed Ovarian Cancer
Rubraca?(rucaparib) offers a new monotherapy option in Europe for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy, regardless of BRCA status
- Positive data from the phase 3 ARIEL3 clinical trial supported this expanded indication making Rubraca available to a larger patient population in an earlier line of therapy
- Rucaparib provided statistically-significant improvement in progression-free survival versus placebo in all patients studied (median 10.8 mos vs 5.4 mos) by investigator assessment
- Most common Grade =3 adverse reaction was anemia; the only serious adverse reaction occurring in >2% was anemia
- Clovis Oncology plans its initial launch of rucaparib as a maintenance therapy in Germany in Q1 2019
Parameter | Investigator assessment | IRR | ||||||||||
Rucaparib | Placebo | Rucaparib | Placebo | |||||||||
All patients | ||||||||||||
Patients, n | 375 | 189 | 375 | 189 | ||||||||
PFS events, n (%) | 234 (62) | 167 (88) | 165 (44) | 133 (70) | ||||||||
PFS, median in months (95% CI) | 10.8 (8.3, 11.4) | 5.4 (5.3, 5.5) | 13.7 (11.0, 19.1) | 5.4 (5.1, 5.5) | ||||||||
HR (95% CI) | 0.36 (0.30, 0.45) | 0.35 (0.28, 0.45) | ||||||||||
p-value | <0.0001 | <0.0001 | ||||||||||
tBRCA Group | ||||||||||||
Patients, n | 130 | 66 | 130 | 66 | ||||||||
PFS events, n (%) | 67 (52) | 56 (85) | 42 (32) | 42 (64) | ||||||||
PFS, median in months (95% CI) | 16.6 (13.4, 22.9) | 5.4 (3.4, 6.7) | 26.8 (19.2, NA) | 5.4 (4.9, 8.1) | ||||||||
HR (95% CI) | 0.23 (0.16, 0.34) | 0.20 (0.13, 0.32) | ||||||||||
p-value | <0.0001 | <0.0001 | ||||||||||
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Clovis Investor Contacts: Anna Sussman, 303.625.5022 asussman@clovisoncology.com or Breanna Burkart, 303.625.5023 bburkart@clovisoncology.com Clovis Media Contacts: U.S. Lisa Guiterman, 301.217.9353 clovismedia@sambrown.com or Christy Curran, 615.414.8668 clovismedia@sambrown.com EU Ann Hughes, +44 (0) 7956 700 790 Ann.Hughes@publicisresolute.com Source: Clovis Oncology, Inc.