Clovis Oncology Announces Presentations at 2018 ASCO Annual Meeting

Accepted abstracts highlight additional data from phase 3 ARIEL3 clinical trial, as well as trials in progress presentations of Rubraca^® (rucaparib) in multiple solid tumor settings at ASCO

Clovis Oncology, Inc. CLVS today announced that seven abstracts highlighting progress in the Rubraca preclinical research and clinical development program will be presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 1-5 in Chicago.

The accepted abstracts include additional data from the phase 3 ARIEL3 clinical trial, as well as summaries of ongoing preclinical research and multiple clinical trials in which Rubraca is being studied as monotherapy and in combination in cancer types including ovarian, bladder, prostate and breast cancers.

"Rubraca has demonstrated its ability to reduce the risk of disease progression following platinum-based chemotherapy for women with advanced ovarian cancer, and our team is dedicated to fully exploring the potential of this molecule as a new treatment option for patients being treated for other cancer types where PARP inhibitors have shown encouraging results," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to sharing updates on the progress of our clinical development program at ASCO 2018."

The four Clovis Oncology-sponsored abstracts accepted for presentation at the 2018 ASCO Annual Meeting comprise:

Abstract TPS4592 (Poster 415a) - ATLAS: A phase 2, open-label study of rucaparib in patients (pts) with locally advanced or metastatic urothelial carcinoma (mUC).

• Presenter: Petros Grivas, MD, PhD, University of Washington
• Session: Genitourinary (Nonprostate) Cancer
• Date/Time: Saturday, June 2, 8:00 -11:30 a.m. CT
• Location: Hall A

Abstract 5537 (Poster 264) – Evaluation of rucaparib in platinum-sensitive recurrent ovarian carcinoma (rOC) in patients (pts) with or without residual bulky disease at baseline in the ARIEL3 study.

• Presenter: Carol Aghajanian, MD, Memorial Sloan Kettering Cancer Center
• Session: Gynecologic Cancer
• Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
• Location: Hall A

Abstract 5545 (Poster 272) – Exploratory analysis of percentage of genomic loss of heterozygosity (LOH) in patients with platinum-sensitive recurrent ovarian carcinoma (rOC) in ARIEL3.

• Presenter: Ana Oaknin, MD, PhD, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO)
• Session: Gynecologic Cancer
• Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
• Location: Hall A

Abstract 5582 (Poster 309) – Efficacy and immune modulation of the tumor microenvironment with the combination of the PARP inhibitor rucaparib and CD122-biased agonist NKTR-214.

• Presenter: Andrew Simmons, PhD, Clovis Oncology
• Session: Gynecologic Cancer
• Date/Time: Monday, June 4, 1:15 -4:45 p.m. CT
• Location: Hall A

Additionally, three additional collaborator and investigator sponsored abstracts investigating Rubraca in metastatic breast and prostate cancers are also being presented:

Abstract TPS1112 (Poster 187a) – An open-label, phase II study of rucaparib, a PARP inhibitor, in HER2- metastatic breast cancer patients with high genomic loss of heterozygosity.

• Presenter: Anne Patsouris, Institute of West Cancerology Paul Papin
• Session: Breast Cancer - Metastatic
• Date/Time: Saturday, June 2, 8:00-11:30 a.m. CT
• Location: Hall A

Abstract TPS5095 (Poster 317b) – Phase II trial of rucaparib (without ADT) in patients with metastatic hormone-sensitive prostate cancer harboring germline DNA repair gene mutations (TRIUMPH).

• Presenter: Mark Christopher Markowski, MD, PhD, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
• Session: Genitourinary (Prostate) Cancer
• Date/Time: Saturday, June 2, 1:15-4:45 p.m. CT
• Location: Hall A

Abstract TPS3126 (Poster 327b) – An open-label, phase 2 study of nivolumab in combination with either rucaparib, docetaxel, or enzalutamide in men with castration-resistant metastatic prostate cancer (mCRPC; CheckMate 9KD).

• Presenter: Karim Fizazi, MD, PhD, Gustave Roussy
• Session: Developmental Therapeutics—Immunotherapy
• Date/Time: Monday, June 4, 8:00-11:30 a.m. CT
• Location: Hall A

Clovis Oncology's Rubraca posters will be available online at http://clovisoncology.com/pipeline/scientific-presentations/ as of the time they are presented at the meeting.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca is an unlicensed medical product outside of the U.S.

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 the timing and pace of commencement of and enrollment in our clinical trials, including those being planned or conducted in collaboration with partners. 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 our clinical development programs for our drug candidates and those of our partners, the corresponding development pathways of our companion diagnostics, the timing of availability of data from our clinical trials and the results, the initiation, enrollment and timing of our planned clinical trials, 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 regarding drug labeling, reimbursement and pricing, and other matters that could affect the development, 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.

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