Three days after Bristol-Myers Squibb filed for FDA approval of the NS5A drug daclatasvir combined with asunaprevir, an NS3 protease inhibitor, the biotech company ($BMY) has turned over some of the Phase III cards it will be playing for an approval in markets around the world.
Investigators say that the combo produced a sustained virological response of 90% in one group of patients in the genotype 1b pool, with other treatment-resistant populations registering in the low- to mid-80s. That may well prove good enough for an approval, but the results will also likely trigger considerable jockeying with rival all-oral combination therapies nearing the market.
In the study, 90% of treatment-naïve patients achieved a sustained virological response 12 weeks after treatment ended; 82% of patients resistant to a combination of peginterferon and ribavirin achieved SVR12; and 82% of peginterferon/ribavirin ineligible or intolerant patients achieved SVR12. Among the peginterferon/ribavirin ineligible/intolerant patients, SVR12 was achieved by 91% of patients with anemia/neutropenia, 80% of patients suffering from depression and 73% of a group with advanced fibrosis/cirrhosis with thrombocytopenia.
BMS was definitely thinking globally when it mounted the study. The big biotech notes that there are large genotype 1b populations in Europe as well as Asia, which influenced their site selections for the study.R&D Chief Brian Daniels
"Daclatasvir has unique scientific characteristics that support ongoing research for its use in multiple all-oral HCV regimens," said Brian Daniels, the R&D chief at Bristol-Myers. "In addition to the HALLMARK-Dual study, we are pleased to be presenting data at [the European Association for the Study of the Liver meeting] on our investigational 3DAA fixed-dose-combination, as well as daclatasvir in combination with other HCV compounds."
Just a few weeks ago Bristol-Myers Squibb picked up its second "breakthrough" drug designation for a daclatasvir-based, all-oral combo for hepatitis C from the FDA, potentially shaving some regulatory time off its late-stage program as developers scramble to hijack market share from Gilead's ($GILD) pioneering approach. Last spring their triple drug cocktail, which also includes BMS-791325, an NS5B non-nucleoside polymerase inhibitor, was tapped as a breakthrough for genotype 1 patients.
"In partnership with our biotech team, we are increasing our HCV forecasts for BMY and MRK consistent with the brisk uptake of GILD's Sovaldi in the US and the overall global HCV oppt'y," noted Seamus Fernandez at Leerink. "For BMY, its leadership position with an all-oral two-drug HCV regimen in Japan, competitive positioning with daclatasvir monotherapy, and the triple-drug regimen suggest that BMY should be able to at least achieve sales >$1B in 2018."
Bristol-Myers has earned a sterling reputation for R&D in recent years. Its PD-1 immuno-oncology drug nivolumab is frequently cited as a leader in the race for a market-leading first approval. That said, the biotech has experienced some setbacks in its race to get a cutting-edge hep C therapy on the market, most notably when Gilead rejected its plea to mount a combo late-stage study with Sovaldi, which looked particularly promising at the time.
- here's the release