• European Commission (EC) marketing authorization is anticipated Q1 2019
  • Upon receipt of marketing authorization by the EC, Rubraca will offer a new monotherapy option 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

BOULDER, CO, USA I December 13, 2018 I Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending an additional indication to include rucaparib as monotherapy for the maintenance treatment of adult patients 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. EC approval is anticipated in the first quarter of 2019.

Once approved, Rubraca’s indication will expand beyond its initial Marketing Authorization in Europe granted in May 2018 for adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

The CHMP’s positive opinion for this additional indication was based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.i

“The CHMP recommendation represents an important step forward for women with recurrent ovarian cancer, for whom additional treatment options are needed. The ARIEL3 trial demonstrated rucaparib to be effective across all patient types, regardless of their BRCA mutation status, and is the only PARP-inhibitor trial in which independent radiological review reported a median progression-free survival of more than one year across the entire population studied,” said Professor Jonathan Ledermann, MD, Professor of Medical Oncology, UCL Cancer Institute and UCL Hospitals, London, global Principal Investigator for non-US sites in the ARIEL3 study. “The meaningful efficacy data and tolerable safety profile offers women diagnosed with relapsed ovarian cancer a new therapy option.”

Ovarian cancer is the sixth deadliest cancer amongst women in Europe, where more than 65,000 women are diagnosed annually.ii Ovarian cancer is challenging to treat, and most women will relapse after surgery and chemotherapy. The 80 to 85 percent of women diagnosed in the later stages of the disease (III and IV) have particularly poor outcomes.iii

“We are pleased that the CHMP recognizes the clinical relevance of rucaparib in the maintenance treatment setting for European women with relapsed platinum-sensitive ovarian cancer,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “This brings us a step closer to delivering on our commitment to ensure that women who may benefit from treatment with rucaparib have the opportunity to do so. We seek to make ovarian cancer an actively managed disease, rather than one that is treated and then wait for recurrence. Rucaparib’s clinical benefit in the maintenance treatment setting is supported by the pivotal ARIEL3 study, which showed that Rubraca provided benefit in all ovarian cancer patient populations studied.”

About the ARIEL3 Pivotal Study

ARIEL3 is a double-blind, placebo-controlled trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer. The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) BRCA mutant (BRCAmut+); 2) HRD positive (HRD+) inclusive of BRCA mutant; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3. The study achieved its primary endpoint of improved PFS by investigator review in each of three populations.

About Rubraca® (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

In October 2018, Rubraca was granted Breakthrough Therapy Designation by the FDA as monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy.

Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and Europe.

Rucaparib EU Authorized Use

Rucaparib is indicated for adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

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About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco and Oakland, California and Cambridge, UK. Please visit clovisoncology.com for more information.

i Coleman RL et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2017;390:1949-1961.
ii World Health Organization. Globocan 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012. Accessed 23 February 2018.
iii American Cancer Society. Survival rates for ovarian cancer, by stage. https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/survival-rates.html

SOURCE: Clovis Oncology