What happened
Shares of Clovis Oncology (CLVS +0.00%) jumped 80% this week, according to data from S&P Global Market Intelligence. The stock closed at $1.60 last Friday, then opened on Monday at $1.62. Clovis' big move didn't come until Thursday, however, when the company announced positive data regarding its drug Rubraca (rucaparib). The stock, after closing at $1.65 on Wednesday, opened at $2.33 on Thursday and rose as high as $2.88 in the first hour of trading. It was a big development for the company as its shares had fallen significantly from last year, when it was trading as high as $11 a share early in February.
So what
Clovis said its phase 3 trial found Rubraca extended the progression-free survival rate in ovarian cancer to 20.2 months, compared to an average of 9.2 months in the placebo group.
OTC: CLVS
Key Data Points
The drug works by inhibiting poly (ADP-ribose) polymerase (PARP), robbing tumor cells of their ability to repair their DNA. However, it isn't the only PARP inhibitor on the market with Lynparza, sold by AstraZeneca and Merck, earning $2.3 billion in sales in 2021.
"The results from the ATHENA-MONO study of Rubraca in first-line maintenance treatment [of] ovarian cancer exceeded our expectations," said Clovis President and CEO Patrick J. Mahaffy in the company's announcement. "We believe that the positive results from ATHENA-MONO demonstrate that Rubraca will provide an important new treatment option for women with advanced ovarian cancer in the first-line maintenance setting, and we look forward to submitting these data to the regulatory authorities in the U.S. and Europe during Q2 and Q3 2022, respectively."
Image source: Getty Images.
Clovis said it expects to file a supplemental New Drug Application to the Food and Drug Administration during the second quarter for a first-line treatment for patients with advanced ovarian cancer who have responded to first-line platinum-based chemotherapy. The drug, which the company purchased from Pfizer in 2011, has already been approved to treat patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in the United States and Europe. It also has been approved as a monotherapy for adults with the breast cancer gene, in addition metastatic castrate-resistant prostate cancer with tumors that have a genetic mutation. With the latest results, the company could market the drug as a first-line therapy to treat ovarian cancer. According to National Cancer Institute (NCI) data, 21,410 patients were diagnosed with the disease last year, and there were 13,770 deaths from the disease in 2021 in the United States. Ovarian cancer has a low survival rate, 49.1%, based on NCI data from 2011 to 2017.
Now what
The news should be a shot in the arm for the biotech company, which reported $148.8 million in revenue last year, down 9.5% over the prior year. The company has already reined in expenses and lost $2.38 a share last year, an improvement from the $4.38-per-share loss it reported in 2020. The additional revenue from another indication will help the company pay for its small pipeline, which includes several cancer therapies in early-stage trials.
