Clovis Stalls Mid-Stage Rubraca Study for Bladder Cancer

Clovis Oncology, Inc. CLVS, in a SEC filing, announced the discontinuation of a phase II ATLAS study evaluating Rubraca (rucaparib) monotherapy for treating recurrent, metastatic bladder cancer. The decision is based on a recommendation from an independent data monitoring committee, which reviewed preliminary efficacy data from 62 patients enrolled in the study. Analysis of the preliminary objective response rate (“ORR”) suggested that Rubraca monotherapy is unlikely to provide a meaningful clinical benefit to patients.

However, the company said it will continue development of Rubraca in advanced bladder cancer in combination with other therapies. A phase II ARIES study has been designed to evaluate Rubraca in combination with Bristol-Myers’ BMY Opdivo for locally advanced unresectable/metastatic bladder cancer. The company will start enrolling patients in the study in the second half of 2019.

Clovis’ shares declined 1.2% on Apr 12, following the news However, so far this year, the stock has increased 30.7%, outperforming the industry’s rise of 8.7%.

We would like to remind investors that Rubraca is already approved as a maintenance treatment for the recurrent ovarian cancer patients, irrespective of BRCA-mutation, who have received one prior platinum-based chemotherapy.

Rubraca generated sales of $95.4 million in 2018, reflecting a surge of 71.9% year over year. The drug’s sales have improved steadily since its launch. However, the target market is highly competitive with the presence of Glaxo’s GSK Zejula and Merck/AstraZeneca’s AZN Lynparza.

Meanwhile, Clovis is investigating Rubraca in several label expansion studies. A phase III confirmatory study — ARIEL4 — is evaluating Rubraca versus chemotherapy in patients, who have failed two prior lines of therapy. A phase III study — ATHENA — is probing Rubraca plus Opdivo as part of the alliance with Bristol-Myers for advanced ovarian cancer. Clovis is also looking to expand Rubraca’s label into additional cancer types like prostrate, breast and gastroesophageal cancers among others.

Earlier this month, Clovis announced interim results from a phase II study on Rubraca for the first-line maintenance treatment of advanced pancreatic cancer in platinum-sensitive patients. Interim data from the study showed that treatment with Rubraca led to disease-control benefit with no new safety signals in patients.

Clovis Oncology, Inc. Price

 

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Zacks Rank

Clovis currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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