ESMO: Clovis seeking new indication on positive ARIEL3 data
- Clovis Oncology, Inc. presented positive data from the Phase 3 ARIEL3 trial at the European Society of Medical Oncology (ESMO) in Spain this week.
- The data showed that Clovis' PARP inhibitor Rubraca improved progression-free survival (PFS) in all three populations of advanced ovarian cancer patients that were studied when tested against a placebo.
- Based on the results, Clovis plans to file a supplemental New Drug Application (sNDA) with the Food and Drug Administration to expand Rubraca’s approval to second-line maintenance treatment in all advanced ovarian cancer patients, regardless of genetic markers.
The 564-patient study tested the drug in advanced ovarian cancer patients, looking specifically at three subgroups: those with the BRCA mutation, those with a homologous recombination deficiency (HRD) and the overall intent-to-treat study population.
The trial found the drug improved PFS in all three subgroups, showing Rubraca (rucaparib) provided 13.7 months of median PFS.
Rubraca was approved in the U.S. in December for advanced ovarian cancer patients that are positive for the BRCA mutation and have had at least two prior courses of chemotherapy.
Patients with BRCA-mutated cancers — the population Rubraca is already approved for — showed the greatest improvement in the trial, notching a median PFS of 16.6. Numbers for the overall study population were lower, at 10.8 months, but still double the placebo group mark of 5.4 months.
Clovis is hoping these results can help it outpace rival PARP inhibitors from AstraZeneca plc and Tesaro Inc.
All three drugs have shown results broadly in the same ballpark. But Clovis is hoping Rubraca's ability to clear residual tumors could help it stay competitive.
ARIEL3 included a third of patients who had a complete response to prior treatment, and two-thirds who only had partial responses and still had residual tumors. In the BRCA-positive group, Rubraca helped shrink tumors in 38% of patient and clear tumors in 18%. Among the entire intent-to-treat population, treatment with Rubraca led to an overall response rate of 18%, inclusive of a 7% complete response rate.
These results suggest a benefit from Rubraca beyond preventing disease recurrence, which could be help Clovis keep up with AstraZeneca and Tesaro.
- Clovis Oncology Press release
Follow Lisa LaMotta on Twitter