=Clovis Oncology (CLVS) : ovarian cancer drug Rubraca succeeds in key study

• Tesaro (TSRO), which has its own ovarian cancer drug treatment Zejula, tumbled 11%. Drug giant AstraZeneca (AZN), which could see its Lynparza market share pressured, fell a fraction.
• Rubraca, along with Tesaro's Zejula and AstraZeneca's Lynparza, are so-called PARP inhibitors. PARP inhibitors work by blocking a family of enzymes that cancer cells use to proliferate. Pfizer (PFE) and AbbVie (ABBV) are also working on PARP inhibitors. Credit Suisse analyst Alethia Young sees the class of drugs also having an impact in prostate, breast and lung cancers.

June 19 (Reuters) - Clovis Oncology Inc said its ovarian cancer drug Rubraca slowed disease progression in a late-stage trial involving patients with various gene mutations who had undergone initial therapy.

The U.S. Food and Drug Administration last December granted Rubraca accelerated approval in patients whose tumors have a mutation called BRCA, and whose disease had advanced despite two or more rounds of chemotherapy.

Based on the findings of the trial announced on Monday, Clovis plans to submit an application within the next four months to expand Rubraca's label.

Rubraca, like Tesaro Inc's niraparib and AstraZeneca Plc's lynparza, belongs to a closely watched class of new medicines called PARP inhibitors, which block enzymes involved in repairing damaged DNA, thereby helping to kill cancer cells. 

Clovis Oncology reports data from Phase 3 ARIEL3 study achieved primary endpoint; plans to submit NDA in next 4 months :

• Co announced topline data from the confirmatory phase 3 ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free survival by investigator review in each of the three populations studied.
• PFS was also improved in the rucaparib group compared with placebo by blinded independent central review, a key secondary endpoint.
• Based on these findings, the Company plans to submit a supplemental New Drug Application within the next four months for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy.
• The exploratory PFS endpoints were achieved by both investigator and independent review in the HRD-positive and HRD-negative subgroups of patients without a BRCA mutation
• ARIEL3 patients with residual disease at study entry who were treated with rucaparib showed further reduction in tumor burden, including complete responses
• The safety of rucaparib observed in ARIEL3 was highly consistent with the U.S. treatment label for Rubraca