October 2, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Boulder, Colo.-based Clovis Oncology is being eyed by analysts and investors for its promising results in cancer clinical trials, particularly as it goes head-to-head with AstraZeneca PLC on several of its pipeline products.
On Sept. 9, 2015, Clovis announced two major regulatory milestones for its drug for non-small cell lung cancer (NSCLC), roceletinib. In particular, the drug was used to treat patients who have a specific EGFR T790M mutation. At least two drugs, Iressa (AstraZeneca) and Tarceva (Genentech ), target EGFR. However, in patients with the T790 mutation, these drugs become ineffective. Roceletinib appears effective in the typical EGFR mutation-related NSCLCs, but also blocks the T790 mutation.
The U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for the drug and granted priority review status. News on that is expected on March 30, 2016. The European Medicines Agency (EMA) has also accepted receletinib’s Marketing Authorization Application (MAA). It also was given the EMA’s version of priority review status, which shifts the timeframe from 210 days to 150 days.
UK-based AstraZeneca plc (ADR) has an experimental drug, AZD9291, which has also been given FDA priority review status and the EMA’s accelerated review status. The drug, in clinical trials, delays NSCLC disease progression in pre-treated EGFR T790M mutation-positive patients by about 8.6 months, which is very similar to rociletinib’s eight-month progression-free survival rate.
Both drugs are well-tolerated. AstraZeneca’s drug has side effects of rashes and diarrhea. Clovis’s drug causes hyperglycemia, or high blood sugar.
In a research note, Seamus Fernandez, an analyst with Leerink Partners said, “Heading into WCLC (World Conference On Lung Cancer), feedback from MEDACorp key opinion leaders (KOLs) was that if AZD9291 maintained its three-month PFS advantage over rociletinib as highlighted at ECLC and ASCO, they would use AZD9291 in 80 to 90 percent of T790m+ patients. With these data, most KOLs still prefer AZD9291, but the impact frequency of rash with AZD9291 versus diabetes with rociletinib suggests that AZD9291 may not dominate the market to the degree previously assumed.”
In other words, AstraZeneca wins, but Clovis is a close second, eating away at AstraZeneca’s estimated $3 billion in top annual sales should the drugs actually get to market.
The two companies are also competing with ovarian cancer drugs. Clovis has a PARP inhibitor, rucaparib. In May, Clovis showed positive Phase II results from two studies with the drug. “With these data presented at ASCO, we believe rucaparib has clearly emerged as a unique and best-in-class PARP inhibitor,” said Patrick Mahaffy, president and chief executive officer of Clovis in a statement at the time. “In addition, with our now clinically proven BRCA-like clinical assay, we have validated our commitment to develop rucaparib not only for the 25 percent of women with germline and somatic BRCA mutations, but for the additional approximately 35 percent of women with the prospectively identified BRCA-like signature.”
The company plans to file with the FDA for rucaparib in 2016.
AstraZeneca markets Lynparza, which was approved late in 2014, for ovarian cancer. Lynparza has a more mixed history, having been initially rejected by the FDA’s advisory committee. AstraZeneca released more data and the drug was approved. Rucaparib appears, at least in clinical trials, to be a much better drug. Clovis provided data showing an 82 percent response rate and 9.4 months of median PFS rate in treatment-resistant BRCA mutant advanced ovarian cancer patients compared to a 45 percent rate and 7.1 months PFSA rate in patients that were “BRCA-like.”
Compared to that study data, AstraZeneca’s Lynparza showed a 34 percent response rate at an average of 7.9 months among patients that had been previously treated for BRCA ovarian cancer three times. Should Clovis’s rucaparib get approved with similar results next year, AstraZeneca’s Lynparza with face stiff competition.
There have also been rumors that larger companies, such as Gilead Sciences, Inc. and Roche may be interested in acquiring Clovis.
