Health and Healthcare

Why Clovis Bladder Cancer Treatment Rucaparib Is in Big Trouble

Chris Lange

Published: April 15, 2019 10:40 am

Last Updated: January 30, 2020 10:07 pm

Clovis Oncology Inc. (NASDAQ: CLVS) shares dropped on Monday after the firm announced that it would be halting its midstage trial testing its lead drug in bladder cancer patients. Management may have thought that it could sneak this announcement by late on Friday, but shares are definitely paying the price now.

Ultimately, Clovis said its decision to discontinue the trial was based on recommendations of an independent committee, which suggested that the treatment may not provide a meaningful benefit to patients.

However, the biotech company noted that it would continue to test the drug, Rubraca, in combination with other treatments for bladder cancer. Not to mention, the drug is also being tested in late-stage trials as a treatment for ovarian and prostate cancer.

According to an SEC filing the company posted on Friday:

Clovis is discontinuing its sponsored Phase 2 open-label monotherapy clinical trial evaluating rucaparib in recurrent, metastatic bladder cancer (ATLAS). The decision is based on recommendations by an independent data monitoring committee (DMC) following its review of preliminary efficacy data for 62 patients enrolled and treated in the study, which demonstrated that the objective response rate in the intent-to-treat population does not meet the protocol-defined continuance criteria, and suggests that treatment with monotherapy rucaparib may not provide a meaningful clinical benefit to patients. Therefore, the DMC recommended to stop enrollment to the study, and Clovis has decided to terminate the ATLAS trial early. The recommendation of the DMC was not based on the safety profile of rucaparib in this study population.

Clovis is continuing to evaluate the potential for rucaparib in combination with other agents for the treatment of advanced bladder cancer. Clovis also plans to enroll patients with advanced bladder cancer and selected genetic mutations in a planned pan-tumor trial of rucaparib expected to begin in the second half of 2019.

Excluding Monday’s move, Clovis had outperformed the broad markets, with its stock up about 31% year to date. However, in the past 52 weeks the stock was actually down 62%.

Shares of Clovis were last seen down about 11% at $20.82, in a 52-week range of $11.50 to $59.32. The consensus price target is $32.50.