Clovis Oncology (CLVS): ESMO A Possible Catalyst For Clovis - Stifel
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Stifel analyst, Thomas Schrader, reiterated his Buy rating on shares of Clovis Oncology (NASDAQ: CLVS) ahead of the upcoming ESMO 2016 meeting from October 7-11. This event will feature significant data readouts for both Clovis’ rucaparib (Friday at 8:45 in the morning; NYC time zone) and Tesaro’s niraparib (Saturday at 11:30 in the morning, analyst event that evening).
Both drugs appear to be more active in treatment setting ovarian cancer than the only approved PARP inhibitor – AZ’s olaparib (Lynparza). However, the analyst believes many of the details defining each drug’s risk--reward profile remain important unknowns including the characteristics of the patients.
The FDA has accepted Clovis’ NDA submission, granted the application priority review status, and assigned a PDUFA date of February 23, 2017. This first application is for the relatively straightforward treatment setting – so the medical need is easy to gauge. The FDA has also told Clovis it does not expect to discuss the application at an ODAC panel. We believe the BRCA-mutant response rate of 54% and median DoR of 9.2 months (median prior number of therapies = 3), along with a favorable safety/tolerability profile, should satisfy the requirements for FDA approval. Although patient mix remains unknown, these data seem better than those reported for olaparib. In a similar setting, olaparib’s label lists a response rate of 34% and a median duration of response of 7.9 months.
PARP enzymes help repair single-stranded (ss) DNA breaks so PARP inhibitors lead to the accumulation of ssDNA breaks. Left uncorrected, ssDNA breaks become double-stranded DNA breaks that kill the cell. As a result, there was an early expectation that PARP-inhibitors will synergize with other drugs that cause ssDNA breaks (alkylating agents and radiation) and be more effective in cells unable to repair dsDNA breaks. This later hypothesis was rapidly confirmed by showing PARP inhibitors were highly synergistic with BRCA mutations that impair dsDNA breaks. More recently, it has become appreciated that PARP inhibitors will be synergistic with other mutations in DNA repair enzymes. This property is one of the most important features of these drugs as it makes PARP inhibitors unusually active against mature and highly mutated tumors.
All the PARP inhibitors have a pretty significant toxicity profiles with fatigue, nausea and hematological toxicity as the major offenders.
along with a price target of $45.
Shares of Clovis Oncology closed at $35.35 yesterday.
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