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Clovis Oncology - Back On Track

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Shares of Clovis Oncology Inc. (CLVS) are up an impressive 48% year-to-date while the iShares Nasdaq Biotechnology ETF (IBB) index has gained only 19% during the same period.

Clovis Oncology is a commercial-stage biotechnology company focused on acquiring, developing and commercializing cancer treatments in the United States, Europe, and other international markets.

The Company has 1 marketed drug - Rubraca, which is indicated for the treatment of patients with deleterious BRCA mutation-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies; and 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.

The drug was launched in the U.S. in December 2016, and awaits the initial European launch in Germany on March 1, 2019.

Sales of Rubraca in the U.S. have steadily increased since its launch as can be seen from the numbers - $78 thousand in full-year 2016; $55.5 million in 2017; and $95.4 million in 2018.

Rubraca is also being explored as a single-agent in a variety of solid tumor types, including prostate and bladder cancers.

-- A single-arm phase II monotherapy study of Rubraca in recurrent, metastatic bladder cancer, dubbed ATLAS, is underway - with initial data anticipated at a Fall 2019 medical meeting.
-- A phase III study comparing Rubraca to physician's choice of androgen-receptor-targeted therapy or chemotherapy in prostate cancer patients, dubbed TRITON3 is ongoing.
-- A phase II single-arm study of Rubraca in prostate cancer patients, dubbed TRITON2, is underway - with updated data anticipated at a Fall 2019 medical meeting.

The other ongoing clinical trials with Rubraca are:

-- A phase III study of Rubraca versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of therapy, dubbed ARIEL4.
-- A phase III study in advanced ovarian cancer in the first-line maintenance treatment setting evaluating Rubraca plus Opdivo, Rubraca, Opdivo and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy, dubbed ATHENA.
-- A phase I study, known as RUCA-J, evaluating 600mg BID dose (two times) of Rubraca in Japanese patients.
-- A phase II study evaluating the combination of Rubraca and Opdivo in patients with relapsed ovarian cancer and patients with locally advanced or metastatic bladder carcinoma, dubbed ARIES. This study is sponsored by Clovis and is expected to begin enrolling patients in the first half of 2019.
-- A phase I/II combination study of sacituzumab govitecan and Rubraca for the treatment of advanced metastatic triple-negative breast cancer, relapsed platinum-resistant ovarian cancer, and metastatic urothelial cancers is expected to begin enrolling patients in 2019.
-- A phase II combination study of Opdivo with Rubraca for the treatment of metastatic castration-resistant prostate cancer, sponsored by Bristol-Myers Squibb, is currently enrolling patients.

There is one more drug candidate in Clovis Oncology's pipeline - Lucitanib. This compound was previously evaluated in breast and lung cancers by Clovis in partnership with French pharmaceutical company Servier. However, data in breast and lung cancer trials were insufficient to move the program forward.

Clovis now owns the global rights (excluding China) to Lucitanib. A study of Lucitanib in combination with Rubraca is expected to be initiated before the end of Q1, 2019.

The Company ended December 31, 2018, with cash of $520.1 million.

CLVS has traded in a range of $11.50 to $65.24 in the last 1 year. The stock closed Tuesday's trading at $26.05, up 2.28%.

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