By Manojna Maddipatla and Tamara Mathias
(Reuters) – BeiGene Ltd said on Monday a late-stage trial failed to show that its cancer treatment Brukinsa was superior to Imbruvica, a rival drug from Johnson & Johnson and AbbVie Inc. The results come merely a month after BeiGene scored a win with Brukinsa’s approval to treat patients with mantle cell lymphoma, who have received at least one prior therapy.
U.S.-listed shares of BeiGene fell 5.2% to $166.9 in early trading on Monday.
The latest trial compared the drugs in 229 patients with Waldenström’s Macroglobulinemia (WM), a rare, slow-growing blood cell cancer characterized by an excess of abnormal white blood cells in the bone marrow.
Brukinsa did not achieve the comparative study’s main goals of showing greater reduction in cancer signs compared with Imbruvica and in reducing at least 90% of production of an antibody that overproduced in patients with WM.
However, it did show greater improvements in safety and tolerability, BeiGene said.
There is sufficient data from the comparative study to have a discussion with the U.S. Food and Drug Administration and the European Medicines Agency for Brukinsa’s approval in WM, the company said and added that it was too early to talk about regulatory filing.
“It is unlikely that we would do other trials, I think that there’s potential that with longer follow up this trial in and of itself could suffice,” Eric Hendrick, chief adviser at BeiGene, told Reuters.
Despite Monday’s failure, the trial data suggests Brukinsa has a differentiated safety profile, with fewer patients discontinuing treatment due to side effects, SVB Leerink analyst Andrew Berens said.
Four patients on Brukinsa discontinued the treatment due to adverse events and there was one death, while the group receiving Imbruvica witnessed nine discontinuations from side effects and four deaths, BeiGene said.
Like Imbruvica, Brukinsa belongs to a class of drugs called Bruton’s tyrosine kinase (BTK) inhibitors. It also competes against AstraZeneca Plc’s Calquence, another BTK inhibitor.
BeiGene likely faces an uphill commercial battle versus Imbruvica and Calquence without positive head-to-head data, Guggenheim analyst Michael Schmidt said.
Brukinsa is currently priced at $12,935 for a 30-day supply, roughly at parity with Imbruvica and slightly below Calquence.
The company said it does not believe the trial results cause it to rethink its strategy around Brukinsa’s pricing.
WM affects about 3 per million people each year in the United States, according to the National Institutes of Health.
(Reporting by Tamara Mathias and Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta and Sriraj Kalluvila)