Clovis (CLVS) Focuses on Rubraca Growth Amid Rising Competition

Clovis Oncology, Inc. CLVS has only one marketed drug in its portfolio — a PARP inhibitor, namely Rubraca (rucaparib) — that is approved for the treatment of certain patients with ovarian and prostate cancer.

Currently, Rubraca is approved in the United States for two indications specific to ovarian cancer in the second- and third or later-line setting. The drug is also approved in the United States under accelerated approval as monotherapy for treating BRCA-mutant metastatic castrate-resistant prostate cancer (mCRPC).

During the first half of 2021, Rubraca’s reported sales of $74.9 million were down 9.2% year over year. The decline in sales was attributed to the continuing impact of the COVID-19 pandemic.

We note that though sales have been declining, Rubraca holds bright prospects for the ovarian cancer market. Clovis is also evaluating Rubraca in several label expansion studies across ovarian cancer. Rubraca is being evaluated in a phase III ATHENA study, both as a monotherapy and in combination with Bristol Myers’ BMY Opdivo in advanced ovarian cancer as a first-line maintenance treatment. Data from this study is expected in 2022.

Since the drug was approved by the FDA under accelerated approval setting for mCRPC, a confirmatory phase III TRITON 3 study is evaluating Rubraca in mCRPC patients. Data from this study is anticipated in second-quarter 2022.Clovis is also conducting a head-to-head phase III CASPAR study comparing the efficacy of Rubraca plus Pfizer’s PFE Xtandi with Xtandi alone in mCRPC patients.

Rubraca also has the potential to treat additional prostate, breast, pancreatic, bladder and gastroesophageal cancers. The company has also entered into collaboration with Merck MRK to develop Rubraca in combination with Keytruda for treating several cancer indications.

Rubraca faces intense competition from PARP inhibitors marketed by pharma bigwigs like Merck/AstraZeneca’s Lynparza and Glaxo’s Zejula, approved for ovarian cancer. These big pharma companies have strong cash resources to promote their drugs, which can push Clovis on the back foot.

We note that while the company has other candidates in its pipeline, they are all in early-stage development. It is evaluating lucitanib in early-stage clinical studies in combination with Rubraca in ovarian cancer or Opdivo in advanced gynecologic cancers and other solid tumors. FAP-2286, its peptide-targeted radionuclide therapy and imaging agent candidate, is also being evaluated across multiple tumor types in a phase I/II LuMIERE study.

Clovis remains primarily reliant on a single drug for growth. A lack of candidates in mid-stage and late-stage clinical studies does not bode well for the stock. An unfavorable outcome from any of the development programs could adversely impact the company’s prospects and the stock performance.

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