- AstraZeneca said Monday its drug Calquence is similarly effective as AbbVie and Johnson & Johnson's Imbruvica in treating patients with a type of leukemia, and could be safer. The data may persuade more physicians to prescribe Calquence, which launched four years after Imbruvica.
- The head-to-head trial, called ELEVATE-RR, found the two drugs were equivalent in keeping patients' disease from progressing, while patients who were treated with Calquence were significantly less likely to develop an irregular heartbeat, a side effect that can result in stroke or heart-related complications.
- The Calquence data underscores growing competition in this drug class, which now includes three marketed therapies — BeiGene's Brukinsa gained approval in 2019. Eli Lilly and Merck & Co. are also developing experimental candidates similar to the other three, which are effective in treating blood cancers like leukemia and lymphoma.
Patients treated with this class of drugs, called Bruton's tyrosine kinase, or BTK, inhibitors, can take them for years, making it essential treatment has few and manageable side effects. The irregular heartbeat, or atrial fibrillation, that sometimes occurs with patients taking Imbruvica can increase their risk of stroke or heart failure, highlighting the need for safer medicines.
ELEVATE-RR enrolled 533 previously treated patients with high-risk cases of a type of disease called chronic lymphocytic leukemia, and randomized them to take either Calquence or Imbruvica. The study was the first Phase 3 head-to-head trial of BTK inhibitors in this disease setting.
The primary goal was determining whether there was any significant difference in disease progression. A secondary endpoint measured whether there was any meaningful difference in occurrence of atrial fibrillation. Other secondary endpoints included infection rate and progression to a severe form of lymphoma, and AstraZeneca said Calquence and Imbruvica were equal on both.
AstraZeneca didn't disclose specific data, but said it will be announced at an upcoming medical meeting. A study called RESONATE found that half of all previously treated chronic lymphocytic leukemia patients given Imbruvica went more than 44 months without experiencing disease progression, so the ELEVATE-RR progression data should look similar.
In overall clinical testing of Imbruvica, 8% of patients on the drug experienced atrial fibrillation, about half of whom couldn't control it using other drugs or medical devices.
In the first nine months of 2020, Imbruvica recorded $3.1 billion in sales, which was split between AbbVie and J&J. By comparison, Calquence had $340 million in sales over the same time period.
Calquence is one of four cancer drugs that are helping AstraZeneca in its shift away from respiratory and cardiovascular medicines. Lung cancer drug Tagrisso is now the British drugmaker's biggest-selling product, with $3.2 billion in sales in the first nine months of 2020.
But the BTK class is a big target of other developers. Eli Lilly is preparing to conduct head-to-head trials of its experimental candidate LOXO-305 against Imbruvica. Merck & Co., meanwhile, acquired a BTK inhibitor via its buyout of ArQule.