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Clovis Oncology, Inc.

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CLOVIS ONCOLOGY ANNOUNCES RUCAPARIB DATA PRESENTATIONS AT ESMO 2016 CONGRESS
Data for rucaparib in the treatment of advanced ovarian cancer to be highlighted in oral presentation
U.S. Food and Drug Administration (FDA) accepted accelerated approval application for review and granted priority review status
Prescription Drug User Fee Act (PDUFA) date is February 23, 2017
European Marketing Authorization Application (MAA) planned in Q4 2016
BOULDER, Colo.--(BUSINESS WIRE)--Sep. 28, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that data from its rucaparib program in ovarian cancer will be presented at the annual European Society for Medical Oncology (ESMO) 2016 Congress. ESMO will take place October 7-11, 2016 in Copenhagen, Denmark. The data being presented comprise the primary efficacy and safety data included in the New Drug Application (NDA) currently under priority review with the FDA.

Rucaparib is the Company’s oral, potent, small molecule inhibitor of PARP1, PARP2 and PARP3 currently being developed for the treatment of advanced ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA (commonly referred to as homologous recombination deficiencies, or HRD). Data from rucaparib studies are the subject of one oral and one poster presentation at the conference:
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Source: press release, 9/28/16. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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FDA ACCEPTS CLOVIS ONCOLOGY’S NEW DRUG APPLICATION FOR RUCAPARIB FOR PRIORITY REVIEW FOR THE TREATMENT OF ADVANCED MUTANT BRCA OVARIAN CANCER
Seeking approval for mutant BRCA patients treated with two or more prior therapies
FDA Grants Priority Review Status
Assigns PDUFA Date of February 23, 2017
BOULDER, Colo.--(BUSINESS WIRE)--Aug. 23, 2016-- Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the U.S. Food and Drug Administration (FDA) has accepted Clovis’ New Drug Application (NDA) for accelerated approval of rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of February 23, 2017. In late June 2016, Clovis completed its NDA submission of rucaparib to the FDA for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test), and who have been treated with two or more chemotherapies. Rucaparib was granted Breakthrough Therapy Designation for the proposed indication by the FDA in April 2015.

“The acceptance of the rucaparib NDA submission represents an important milestone for rucaparib, and for Clovis,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “There is tremendous need for additional therapeutic options for patients with advanced mutant BRCA ovarian cancer and we look forward to cooperating with FDA on the rucaparib NDA review.”

“Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry, or whose tumors have a mutation in the BRCA genes. Despite the available treatment options, few effective therapies are at our disposal. Thus, the opportunity to treat women with germline or somatic BRCA mutations with rucaparib after two prior lines of platinum-based therapy, represents a meaningful step forward for our patients,” said Robert L. Coleman, MD, Professor & Deputy Chairman, Vice Chair, Clinical Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine at University of Texas MD Anderson Cancer Center in Houston and one of the Principal Investigators in the ARIEL clinical trial program.

Foundation Medicine, Clovis’ companion diagnostic partner, has submitted a Premarket Approval (PMA) application for its FoundationFocus CDxBRCA to the FDA in June 2016. The test is designed to identify tumor BRCA mutations, including germline and somatic BRCA mutations. The timing of the submission is expected to allow for regulatory approval of the companion diagnostic in a similar timeframe.
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Source: press release, 8/23/16. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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Patrick J. Mahaffy, President and CEO, gave guidance for completion of the NDA filing for Rucaparib for the treatment of advanced ovarian cancer. He stated, "During the second quarter, we also expect to complete the filing for our first NDA for Rucaparib for the treatment of advanced ovarian cancer. Our U.S. commercial and medical affairs organizations are ready to go, enthusiastic about the potential to launch two oncology drugs in the next 12 months."
Source: Q4 2015 earnings conference call, 2/25/16.

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Rucaparib Ovarian CancerOncologyOvarian Cancer 2nd linePARP1 inhibitorpoly(ADP-Ribose) polymerase (PARP1)

Mechanism of action: Rucaparib is a tricyclic indole poly(ADP-Ribose) polymerase (PARP1) inhibitor with potential chemosensitizing, radiosensitizing, and antineoplastic activities. Rucaparib selectively binds to PARP1 and inhibits PARP1-mediated DNA repair, thereby enhancing the accumulation of DNA strand breaks and promoting genomic instability and apoptosis. This may enhance the cytotoxicity of DNA-damaging agents and reverse tumor cell resistance to chemotherapy and radiation therapy. PARP1 catalyzes post-translational ADP-ribosylation of nuclear proteins and is activated by single-strand DNA (ssDNA) breaks.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2017-02-23

Results:

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ADDING MULTIMEDIA AND CONFERENCE CALL DETAILS CLOVIS ONCOLOGY ANNOUNCES FDA ACCELERATED APPROVAL OF RUBRACA™ (RUCAPARIB) FOR THE MONOTHERAPY TREATMENT OF ADVANCED OVARIAN CANCER IN WOMEN WITH DELETERIOUS GERMLINE OR SOMATIC BRCA MUTATIONS...
First and only PARP inhibitor in the U.S. indicated to treat advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations
Rubraca received approval under the FDA’s accelerated approval program based on objective response rate and duration of response
Most common Grade 3-4 adverse reaction was anemia; most common Grade 3-4 laboratory abnormality was decrease in hemoglobin
BOULDER, Colo.--(BUSINESS WIRE)--Dec. 19, 2016--

Please add multimedia and updated conference call details.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161219006002/en/

BRCA Fact Sheet
BRCA Fact Sheet

The corrected release reads:

CLOVIS ONCOLOGY ANNOUNCES FDA ACCELERATED APPROVAL OF RUBRACA™ (RUCAPARIB) FOR THE MONOTHERAPY TREATMENT OF ADVANCED OVARIAN CANCER IN WOMEN WITH DELETERIOUS GERMLINE OR SOMATIC BRCA MUTATIONS TREATED WITH TWO OR MORE CHEMOTHERAPIES

First and only PARP inhibitor in the U.S. indicated to treat advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations
Rubraca received approval under the FDA’s accelerated approval program based on objective response rate and duration of response
Most common Grade 3-4 adverse reaction was anemia; most common Grade 3-4 laboratory abnormality was decrease in hemoglobin
Clovis Oncology, Inc. (NASDAQ:CLVS) today announced that the U.S. Food and Drug Administration (FDA) has approved Rubraca™ (rucaparib) tablets as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Rubraca’s indication is approved under the FDA’s accelerated approval program, and is based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2 Parts 1 and 2. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The ARIEL3 maintenance confirmatory study has completed enrollment and the ARIEL4 treatment confirmatory study is open for enrollment. Warning and precautions include Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). Please see additional warnings and precautions and Select Important Safety Information below.

“Recurrent ovarian cancer remains one of the most difficult cancers to treat and for so many years, medical advances in this space have been limited,” said Robert L. Coleman, MD, Professor & Deputy Chairman, Vice Chair, Clinical Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine at University of Texas MD Anderson Cancer Center in Houston and one of the Principal Investigators in the ARIEL clinical trial program. “Today’s approval of Rubraca for the treatment of advanced ovarian cancer demonstrates the value of treatment with PARP inhibitors and represents an important advance for women diagnosed with either germline or somatic BRCA-mutated tumors who have been treated with two or more chemotherapies.”

“We believe that today’s approval of Rubraca provides an important new therapy for advanced ovarian cancer patients with a germline or somatic mutation of BRCA after two or more chemotherapies,” said Patrick J. Mahaffy, CEO and President of Clovis Oncology. “We look forward to launching Rubraca with the support of our established U.S. commercial and medical affairs organizations and bringing this much-needed precision medicine to women with advanced ovarian cancer as quickly as possible.”

"NOCC commends Clovis Oncology for its commitment to bringing a new treatment option to women living with ovarian cancer, the deadliest cancer of the female reproductive system. All too often, women are diagnosed when the disease is far advanced, leaving them with few viable treatment options,” said David Barley, Chief Executive Officer, National Ovarian Cancer Coalition. “The development and FDA approval of therapies for use in third-line is a promising step forward for the tens of thousands of women who will battle ovarian cancer in their lifetime."

“Ovarian cancer is one of the most difficult cancers to detect. For this reason, most women who develop ovarian cancer are diagnosed with advanced disease," said Sue Friedman, DVM, Executive Director of Facing Our Risk of Cancer Empowered. "There is a tremendous need for new ways to treat women with advanced ovarian cancer and ways to find those women who will respond to therapies such as PARP inhibitors. PARP inhibitors, like Rubraca, represent an exciting advancement for appropriate patients."

The Rubraca NDA filing received Priority Review and was reviewed and approved under FDA’s Accelerated Approval program. These programs allow for earlier approval of drugs that treat serious conditions and that fill an unmet medical need. The application was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 1 (Study 10, NCT01482715) and Study 2 (ARIEL2 Parts 1 and 2, NCT01891344), in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. All 106 patients received Rubraca 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 and independent radiology review (IRR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Clovis partnered with Foundation Medicine, Inc. to co-develop a companion diagnostic test, the FDA approved FoundationFocusTM CDxBRCA, to select patients for Rubraca treatment. FoundationFocus CDxBRCA is a tissue-based, genomic assay that detects tumor BRCA1 and BRCA2 mutations (germline and/or somatic) in ovarian cancer.

Efficacy and safety results from the U.S. Prescribing Information are summarized below:

Overall Response and Duration of Response in Patients with BRCA-mutant Ovarian Cancer Who Received 2 or More Chemotherapies in Study 1 and Study 2

Table: http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

Response assessment by IRR was 42% (95% CI: 32, 52), with a median DOR of 6.7 months (95% CI: 5.5, 11.1). Investigator-assessed ORR was 66% (52/79; 95% CI: 54, 76) in platinum-sensitive patients, 25% (5/20; 95% CI: 9, 49) in platinum-resistant patients, and 0% (0/7; 95% CI: 0, 41) in platinum-refractory patients. ORR was similar for patients with a BRCA1 gene mutation or BRCA2 gene mutation.

The overall safety evaluation of Rubraca 600 mg twice daily as monotherapy is based on data from 377 patients with ovarian cancer treated in two open-label, single arm trials. The most common adverse reactions (≥ 20% of patients; Grade 1-4) were nausea, asthenia/fatigue, vomiting, anemia, constipation, dysgeusia, decreased appetite, diarrhea, abdominal pain, thrombocytopenia and dyspnea. The most common laboratory abnormalities (≥ 35% of patients; Grade 1-4) were increase in creatinine, increase in ALT, increase in AST, decrease in hemoglobin, decrease in lymphocytes, increase in cholesterol, decrease in platelets and decrease in absolute neutrophil count.
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Source: pressrelease, 12/19/16. http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&I...

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