Tesaro’s closely-watched PARP inhibitor niraparib has aced its first Phase III challenge, racking up a slate of promising outcomes for progression-free survival for advanced, recurring ovarian cancer that will take it straight to the FDA — which has already approved a rival with much worse data.
“This is the first randomized Phase III of a PARP inhibitor to be successful,” says Mary Lynne Hedley, the president and COO of Waltham, MA-based Tesaro ($TSRO).
“The hope would be that following submissions from the NOVA study, we could be in a position to launch niraparib next year,” says CEO Lonnie Moulder, who views the Phase III data as a major milestone for Tesaro.
Investors, who watched the biotech’s shares slide 8% yesterday, drove a 112% spike in the company’s share value in pre-market trading Wednesday morning. Tesaro started the day with a $1.7 billion market cap.
The data highlight a clear impact for the targeted drug in a population of germline BRCA mutation carriers, with a median PFS of 21 months in the drug group compared to 5.5 months in the control arm — a 15.5-month advantage.
But it also did better than that, surprising some doubters in two other targeted patient groups.
For patients who were not germline BRCA mutation carriers but whose tumors were determined to be HRD positive, the niraparib arm hit the primary endpoint with a median PFS of 12.9 months compared to 3.8 months for the control arm. And in the overall non-germline BRCA mutant cohort, which included patients with both HRD-positive and HRD-negative tumors, the PFS was 9.3 months for niraparib compared to 3.9 months for control.
“From the outset, we’ve been quite bullish on the trial design,” Moulder added. “People anticipated niraparib would be successful in germline BRCA mutation.” But there was some controversy over what investigators would likely see in the other two groups, with considerable skepticism about the nongermline group regardless of HRD status.
Running the board with positive outcomes was not expected.
“It’s as good as we could ever hope for,” says the CEO. “It is pretty compelling.”
To provide some added context for the data, the FDA approved AstraZeneca’s Lynparza (olaparib) after an advisory board turned their thumbs down on an approval for ovarian cancer in 2014. The pharma giant’s drug failed a Phase III study on overall survival, but the turnaround team at AZ felt they had a clear shot at an approval anyway.
“This trial (for olaparib) has problems,” FDA cancer chief Richard Pazdur conceded in the panel discussion at the time. If investigators had “pristine evidence of a 7-month advantage in PFS, we wouldn’t be here.”
Now niraparib takes the lead among a group of PARP inhibitors jockeying for a lead position in several cancer types, with J&J taking over the development of the drug for prostate cancer and Tesaro pursuing new indications for other cancer types. AstraZeneca has new data coming out soon, but there’s also considerable attention for Medivation’s talazoparib, which Sanofi has been angling to snatch in a $9.3 billion takeover attempt. (Sanofi tried and failed, in this field with iniparib) Then there’s rucaparib, Clovis’ newest lead drug in the wake of roci’s implosion at the FDA’s doorsteps. And AbbVie has veliparib in the clinic.
Clovis will be put to the test once again, as all the players in this field look to position themselves in a hyper-competitive field.
For Tesaro, a new drug launch for niraparib would give the biotech a second drug to market, following rolapitant’s approval, as it beefs up staff from 300 to about 400 employees.
“Next year with a niraparib launch, we’ll increase our commercial presence 25-30%,” Moulder told me in a recent conversation. “Then we’ll be fully scaled for multiple products.”
— Brad Loncar (@bradloncar) June 29, 2016
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