Clovis Oncology, Inc. CLVS announced interim results from the phase II study on its PARP inhibitor Rubraca (rucaparib) for the first-line maintenance treatment of advanced pancreatic cancer in platinum-sensitive patients.
Interim data from the investigator-initiated program showed that the treatment with Rubraca led to a disease-control benefit with no new safety signals in patients with BRCA1, BRCA2 or PALB2 mutations following the initial treatment with platinum-based chemotherapy. The evaluation is being conducted by The University of Pennsylvania.
The ongoing phase II study is examining Rubraca (600 mg) twice daily as a monotherapy in the first-line maintenance setting. The study will examine 42 patients, whose disease has not progressed following the treatment with platinum-based chemotherapy for at least four months.
The primary endpoint of the study is to observe the progression-free survival (PFS) rate. In 19 patients that were evaluated, the median PFS was 9.1 months from the start of treatment with Rubraca. The median overall survival has not been reached.
The data was presented at the annual meeting of the American Association for Cancer Research (AACR) held in Atlanta.
Clovis is looking for a potential clinical and regulatory path forward for Rubraca in pancreatic cancer. The company expects to provide more information on the same later this year.
Shares of Clovis were up 2.2% following this news on Tuesday. In fact, so far this year, the stock has surged 38%, outperforming the industry’s increase of 11.7%.
We would like to remind investors that Rubraca is already approved as a maintenance treatment for the recurrent ovarian cancer patients, irrespective of BRCA-mutation, who have received one prior platinum-based chemotherapy.
Rubraca generated sales of 95.4 million in 2018, reflecting a 71.9% surge year over year. The drug’s sale has improved steadily since its launch. However, the target market is highly competitive with the presence of Glaxo’s GSK Zejula and Merck/AstraZeneca’s AZN Lynparza.
Meanwhile, Clovis is investigating Rubraca in several label expansion studies. The company has a collaboration with Bristol-Myers BMY to develop Rubraca in combination with the latter’s PD-L1 inhibitor, Opdivo, for several cancer indications.
A phase III confirmatory study — ARIEL4 — is evaluating Rubraca versus chemotherapy in patients, who have failed two prior lines of therapy. A phase III study — ATHENA — is probing Rubraca plus Opdivo as part of the aforesaid alliance for advanced ovarian cancer. Clovis is also looking to expand Rubraca’s label into additional cancer types like prostrate, breast and gastroesophageal cancers among others.
Clovis has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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