Business Wire

Rucaparib MAA for the Ovarian Cancer Treatment Indication Referred by CHMP to Scientific Advisory Group on Oncology for Review Expected in February 2018

Del

Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has requested that the Scientific Advisory Group (SAG) on Oncology provide an opinion on aspects of the ongoing Marketing Authorization Application (MAA) relating to a potential conditional approval for rucaparib. The exact date for the SAG meeting has not yet been set but we expect it to take place in early February 2018.

The SAG on Oncology is convened at the request of the EMA to provide independent recommendations on scientific or technical matters related to pediatric and adult clinical oncology and hematology, or on any other scientific issue relevant to the work of the Agency that relates to this area.

“We continue to have as our priority the submission and potential approval for the maintenance treatment indication in advanced ovarian cancer in the EU,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We anticipate that initiating the process to submit a new MAA for maintenance next month is the quickest path to provide the potential benefit of rucaparib to more women in the EU with advanced disease. Of course, if we receive an approval for the treatment indication in the second quarter, and we file a variation to the treatment MAA, we anticipate the potential maintenance approval would be swifter.”

The CHMP application for the treatment indication currently under review was submitted during the fourth quarter of 2016 and was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. All 106 patients received rucaparib orally 600 mg twice daily as monotherapy until disease progression or unacceptable toxicity. Objective response rate (ORR) and duration of response (DOR) were assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The most common Grade 3/4 adverse event was anemia.

Both the variation to the MAA or a new MAA submission will be 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. 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; 2) HRD-positive; and finally, 3) the intent-to-treat population, or all patients treated in ARIEL3. Both the variation to the MAA or the new MAA filing will be directed at the broader intent-to-treat or “all comers” population.

Clovis announced positive topline results from the ARIEL3 clinical trial in June 2017. The comprehensive dataset from the trial was presented at the 2017 European Society for Medical Oncology (ESMO) Annual Conference in Madrid, Spain,i and subsequently published in The Lancet.ii

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. In December 2017, the US Food and Drug Administration (FDA) accepted the Company’s supplemental New Drug Application (sNDA) for rucaparib for a second-line or later maintenance treatment indication in ovarian cancer based on the ARIEL3 data. The FDA granted Priority Review status to the application with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In December 2017, the CHMP referred the rucaparib MAA for the ovarian cancer treatment indication to the SAG on Oncology for review. The SAG meeting to discuss the rucaparib MAA is anticipated in February 2018. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for rucaparib.

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, California and Cambridge, UK. Please visit clovisoncology.com for more information.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements contained in this press release include, among others, statements regarding our expectation of timing for EMA regulatory steps, European approval of rucaparib for the treatment indication and the filing, review and potential approval of an MAA, or variation to the treatment MAA for a second line or later maintenance indication for rucaparib. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in actions by the FDA, the EMA or other regulatory authorities regarding whether to approve drug applications that may be filed, as well as their decisions that may affect drug labeling, pricing and reimbursement, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

___________________
i Ledermann, J., MD. ARIEL3: A phase 3, randomised, double-blind study of rucaparib vs placebo following response to platinum-based chemotherapy for recurrent ovarian carcinoma (OC). Presented at 2017 European Society for Medical Oncology Congress in Spain, Madrid. 8 September 2017.
ii Coleman R, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. 12 September 2017. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32440-6/fulltext

Contact information

Clovis Investor Contacts:
Anna Sussman, 303-625-5022
asussman@clovisoncology.com
or
Breanna Burkart, 303-625-5023
bburkart@clovisoncology.com
or
Clovis Media Contacts:
US
Lisa Guiterman, 301-217-9353
clovismedia@sambrown.com
or
Christy Curran, 615-414-8668
clovismedia@sambrown.com
or
EU
Ann Hughes, +44 (0) 7956 700 790
Ann.Hughes@publicisresolute.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

A Better Way to Earn Interest on Digital Assets18.1.2019 01:00Pressemelding

Cred, the leading provider of crypto borrowing and lending with over $300 million in credit facilities, today announced the launch of CredEarn* on the Uphold platform. CredEarn allows Uphold customers to lend their crypto and fiat assets to Cred and receive up to 10% of annualized interest. “We’re thrilled to offer consumers the opportunity to earn interest on their digital assets and fiat currencies,” said Dan Schatt, Co-founder and President of Cred. “In a bear market, customers can benefit from the liquidity they receive when obtaining a fixed amount of interest in USD or Stablecoin. In a bull market, customers also benefit by receiving the full upside on the amount of crypto they originally committed.” CredEarn customers can commit to a six-month term with the ability to rollover assets for additional periods. No account minimum is needed and interest is paid out in U.S. Dollars or Stablecoin every three months on Uphold. The principal is paid back in the fiat or crypto amounts tha

Servier and Taiho Oncology Present Latest LONSURF® (trifluridine/tipiracil) Data at ASCO 2019 Gastrointestinal Cancers Symposium (ASCO GI)17.1.2019 23:45Pressemelding

Servier and Taiho Oncology, Inc. (U.S.), a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), jointly announced today that the safety and efficacy data in the gastrectomy patient subgroup of the global Phase III trial TAGS evaluating LONSURF® (trifluridine/tipiracil, TAS-102) in patients with metastatic gastric cancer (mGC) are consistent with the overall study results published in The Lancet Oncology. These data were highlighted in an oral presentation at the ASCO 2019 Gastrointestinal Cancers Symposium (ASCO-GI) on Thursday 17 January. In TAGS, 221 (44%) of the 507 randomized mGC patients had undergone prior gastrectomy (147 LONSURF, 74 placebo), which is reflective of the real-world patient population diagnosed with mGC. The results confirmed that trifluridine/tipiracil prolonged survival versus placebo regardless of prior gastrectomy. The overall results of TAGS demonstrated that patients treated with oral trifluridine/tipiracil showed a clinically meaningful and statistically s

ISACA Announces 2019 Slate of Events for Business Technology Professionals Around the Globe During its 50th Anniversary Year17.1.2019 19:24Pressemelding

ISACA, a global association serving technology audit, assurance, governance and cybersecurity professionals, celebrating its 50th anniversary in 2019, announced its annual event schedule, which includes learning opportunities focused on emerging technologies, innovation, best practices and professional development. Disruptive technologies over the last 50 years and in the future of business enterprise, and the evolution of technology careers and ISACA professions, will be featured in conjunction with the ISACA anniversary year at nearly every venue. ISACA’s growing Cybersecurity Solution Portfolio, including the CSX Training Platform and the CMMI Cybermaturity Platform, will be highlighted in new conferences in 2019, which will include events in North America and Europe. The 2019 CACS conferences, set for North America, Europe, Asia, Africa, the Oceania region and Latin America, will offer educational sessions in audit and assurance, big data, risk management, governance and more. All

HighLife Closes a €32 Million Round B Financing17.1.2019 17:25Pressemelding

HighLife SAS, a medtech company focused on the development of a unique transcatheter mitral valve replacement (“TMVR”) system to treat patients suffering from mitral regurgitation, announced today it had closed a €32 million round of equity financing. Proceeds from the financing will be used to complete the development of the company’s transcatheter transseptal mitral valve implantation program, which includes regulatory approval trials in Europe to obtain the CE mark and a first clinical trial in the U.S. via an Early Feasibility Study (EFS). The Series B round was co-led by U.S. Venture Partners (“USVP”) and Andera Partners, with Sectoral Asset Management and Jose Calle Gordo, Chairman of the company, joining the round. Sofinnova Partners, which led the Series A round, continues to support the company and participated in this latest round of financing. Bryan Garnier & Co (Paris) acted as private placement agent for this financing. “I am very pleased to announce the closing of the Ser

The Brightline™ Initiative, led by Project Management Institute, to Support The Economist Davos Panel17.1.2019 15:00Pressemelding

The Brightline™ Initiative, a coalition dedicated to helping executives bridge the gap between strategy design and delivery, along with Project Management Institute is hosting The Economist Events panel discussion entitled “Humans 2.0: Designing and Implementing a Future Proof Strategy.” In line with Davos’ overarching theme, “Globalization 4.0: Shaping a Global Architecture in the Age of the Fourth Industrial Revolution,” panelists will discuss how business leaders can harness the power of people to adapt and implement corporate strategies and grapple with the effects of disruptive technologies. This topic is of particular interest to PMI, the leading member of Brightline, given how this wave of disruption calls for organizations to rely on successful implementation of new strategies at unprecedented scope and speed to meet market demands. “As a coalition committed to moving from idea to strategy implementation to results, we’re delighted to partner with The Economist Events to bring

MSCI Schedules Investor Conference Call to Review Fourth Quarter and Full Year 2018 Results17.1.2019 14:00Pressemelding

MSCI Inc. (NYSE:MSCI), a leading provider of indexes and portfolio construction and risk management tools and services for global investors, today announced it will release its results for the fourth quarter and full year 2018 on Thursday, January 31, 2019. MSCI's senior management will review the fourth quarter and full year 2018 results on Thursday, January 31, 2019 at 11:00 AM Eastern Time. To listen to the live event, visit the events and presentations section of MSCI's Investor Relations homepage, http://ir.msci.com/events.cfm, or dial 1-877-376-9931 conference ID: 3474708 within the United States. International callers dial 1-720-405-2251 conference ID: 3474708. The earnings release and related investor presentation used during the conference call will be made available on MSCI's Investor Relations homepage. An audio recording of the conference call will be available on our Investor Relations website, http://ir.msci.com/events.cfm, beginning approximately two hours after the conc