Clovis Oncology Announces Data Presentations at 2015 European Cancer Congress

Clovis Oncology (NASDAQ:CLVS) today announced that three oral presentations and four scientific posters highlighting updated results from clinical studies of the company’s two compounds in advanced clinical development are being presented at the 2015 European Cancer Congress (ECC), which will take place Sept. 25-29 in Vienna, Austria.

"We are pleased to have the opportunity to share significant clinical progress across our product pipeline at ECC this year,” said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "Some key highlights include updated results from our rucaparib studies in the treatment of advanced ovarian cancer, including ARIEL2, for which we intend to file our initial regulatory submissions in the US in mid-2016.”

Rucaparib, the Company’s oral, potent, small molecule inhibitor of PARP1 and PARP2 being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA such as high genomic LOH (also referred to as "BRCA-like”), is the subject of two oral presentations and two posters:

Abstract #2700 – Final results of ARIEL2 (Part 1): a Phase 2 trial to prospectively identify ovarian cancer (OC) responders to rucaparib using tumor genetic analysis

• R Kristeleit
• Tuesday, Sept. 29, 9-9:15am CEST
• Room: Hall A2

Abstract #2701 – Quantification of genomic loss of heterzygosity enables prospective selection of ovarian cancer patients who may derive benefit from the PARP inhibitor rucaparib

• A Oza
• Tuesday, Sept. 29, 9:15-9:30am CEST
• Room: Hall A2

Poster # P409 – A phase 2 open-label, multicenter study of single-agent rucaparib in the treatment of patients with relapsed ovarian cancer and a deleterious BRCA mutation

• R Shapira-Frommer
• Monday, Sept. 28, 2015, 9:15-11:15am CEST
• Room: Hall C

Rociletinib, the Company’s oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC), is the subject of one oral and three posters presentations:

Abstract #3009 – Activity of rociletinib in EGFR mutant NSCLC patients with a history of CNS involvement

• A Varga
• Monday, Sept. 28, 10:10-10:25am CEST
• Room: Strauss

Poster # P356 – Rociletinib treatment and outcomes in non-small cell lung cancer (NSCLC) patients with negative central testing for T790M

• B Soloman
• Sunday, Sept. 27, 9:15-11:15am CEST
• Room: Hall C

Poster # P356 – Efficacy of rociletinib (CO-1686) in EGFR-mutant non-small cell lung cancer (NSCLC) patients assessed with a plasma EGFR test

• S Gadgeel
• Sunday, Sept. 27, 9:15-11:15am CEST
• Room: Hall C

Poster # P357 – Dose optimization of rociletinib for EGFR mutated NSCLC: Benefit/risk analysis from the TIGER-X trial

• JC Soria
• Sunday, Sept. 27, 9:15-11:15am CEST
• Room: Hall C

About Rucaparib

Rucaparib is an oral, potent small molecule inhibitor of PARP1 and PARP2 being developed for the treatment of ovarian cancer, specifically in patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, such as high genomic LOH, which is commonly referred to as "BRCA-like." Rucaparib was granted Breakthrough Therapy designation by the U.S. FDA in April 2015.

About Rociletinib

Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M, which develops in approximately 60 percent of patients treated with first- and second-generation EGFR inhibitors, while sparing wild-type, or "normal” EGFR at anticipated therapeutic doses. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.

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 diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado.

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. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those 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, the corresponding development pathways of our companion diagnostics, 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, and other matters that could affect the availability or commercial potential of our drug candidates or companion diagnostics, including competitive developments. 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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