UPDATE 4-Clovis's ovarian cancer drug set for label expansion, shares soar
* Co to apply for U.S. label expansion within 4 mths
* Shares surge more than 50 pct
* Rival Tesaro's shares slip 3 pct
(Adds analyst comment; updates shares)
By Natalie GroverJune 19 (Reuters) - Clovis Oncology Inc <CLVS.O> said on
Monday late-stage data on its already-approved ovarian cancer
drug showed that the treatment could benefit four times as many
patients, sending shares of the U.S. biotech soaring 50 percent.
Clovis's late-stage trial was designed to move its drug,
Rubraca, up to a second-line treatment and later, a maintenance
treatment. Maintenance therapy immediately follows initial
treatment to keep patients cancer-free if they go into
Rubraca, like Tesaro Inc's <TSRO.O> Zejula and AstraZeneca
Plc's <AZN.L> Lynparza, belongs to a closely watched class of
new medicines called PARP inhibitors, which blocks enzymes that
repair damaged DNA, helping kill cancer cells in the process.
Rubraca was granted accelerated approval in December by the
U.S. Food and Drug Administration (FDA) to treat patients whose
cancer tested positive for defective BRCA genes, and whose
disease had advanced despite two or more rounds of chemotherapy.
BRCA gene mutations are known to raise the risk of breast
and ovarian cancers.
Clovis's latest study included 564 patients and tested
Rubraca against a placebo in patients with various gene
mutations who had undergone initial platinum-based chemotherapy.
When given Rubraca, women with recurrent ovarian cancer
lived a median 10.8 months without their disease worsening,
compared with 5.4 months for women on a placebo, Clovis said.
Overall, data showed Rubraca slowed recurrence in patients
who were in remission, and shrunk tumors in those who entered
the study with residual disease, in some cases even eliminating
Shares of Tesaro, whose Zejula is already approved as a
maintenance treatment for ovarian cancer, were off 3.6 percent
at $139.12 in morning trading.
"Rubraca and Zejula appear to be more similar than
different, leading to a narrowing of the valuation gap between
Clovis and Tesaro," Morgan Stanley analysts said.
Clovis plans to submit an application to the U.S. FDA within
the next four months to expand Rubraca's label.
If approved, the drug could be used as a maintenance
therapy, or to treat the cancer if the patient prefers to wait
for real evidence that the tumor has recurred, Clovis CEO
Patrick Mahaffy said.
More than 22,400 American women will be diagnosed with
ovarian cancer this year, according to the American Cancer
About 25 percent of those diagnosed will carry BRCA
mutations, Mahaffy said, adding that with an expanded label,
Rubraca's addressable population could effectively quadruple.
Shares of Boulder, Colorado-based Clovis were up 48 percent
at $88.76 in morning trading.
(Reporting by Natalie Grover in Bengaluru; Editing by Amrutha
Gayathri and Sai Sachin Ravikumar)
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Keywords: CLOVIS STUDY/ (UPDATE 4)