Another day, another label-extension trial disappointment for Johnson & Johnson and Bayer’s blood thinner Xarelto. This time the drug fell short in the Commander HF trial, failing to show a benefit over placebo on death and cardiovascular events in patients with worsening heart failure.
The data, presented at the European Society of Cardiology meeting today, should “close the door” on the theory that this very sick heart failure population could be treated with antithrombin therapy, Commander HF’s lead investigator, Professor Faiez Zannad of the University of Lorraine in France, said during a press conference today.
The study enrolled patients who had recently been hospitalised for heart failure. A major cause of death in this population is progressive pump failure, “which does not seem to be affected by intervening in the coagulation cascade”, Jim List, head of J&J's cardiovascular and metabolism, told Vantage on the sidelines of the conference.
Still, he was upbeat, adding that Xarelto could have utility in a more stable heart failure population, an opinion echoed by Professor Zannad. Notably, the successful Compass trial of Xarelto in coronary and peripheral artery disease also included some stable heart failure patients (ESC 2017 – Bleeding blunts Xarelto’s Compass victory, August 27, 2017).
One finding from Commander HF that might be worth exploring was a stroke, where there was a 34% reduction in risk with Xarelto. However, as the primary endpoint was not met, this can only be treated as an exploratory finding.
In any case, doctors attending the ESC congress were not convinced: a vote from the audience revealed that 91% would not give Xarelto to patients admitted for heart failure.
Mr List is adamant that the huge label-expansion effort for Xarelto, which includes studies in around 275,000 patients, has been useful. “We’re better understanding in which patients and for which purposes Xarelto works very well,” he said.
But today's slip-up in Commander HF, coming so soon after the failure of the Mariner trial yesterday, raise doubts about J&J and Bayer’s label-expansion strategy for their key drug (ESC 2018 – Xarelto’s defence all at sea after Mariner flop, August 26, 2018). And the advantage once against rests with the drug's big rival, Bristol-Myers Squibb and Pfizer's Eliquis.