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BeiGene heaps more pressure on AbbVie, J&J with new Brukinsa head-to-head win over Imbruvica

As BeiGene gears up for an all-out war against AbbVie and Johnson & Johnson’s Imbruvica, the company has turned in more clinical evidence to show it has the winning BTK inhibitor to fight certain blood cancers.

BeiGene’s Brukinsa trounced Imbruvica at preventing disease progression or death in patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), BeiGene said Wednesday.

The data come from the final analysis of the phase 3 ALPINE trial. In the study, Brukinsa showed superiority as assessed by both an independent data review committee and investigator, according to BeiGene.

Brukinsa’s latest progression-free survival win deals another blow to Imbruvica in the rivals’ upcoming face-off in the all-important CLL/SLL arena. Brukinsa last year showed a statistically significant improvement on tumor shrinkage during an interim analysis of the ALPINE study, thereby hitting the study’s primary endpoint.

BeiGene didn’t share detailed tumor progression data in Wednesday’s announcement. The company’s earlier investigator analysis found that Brukinsa shrank tumors in 78.3% of patients, versus 62.5% in the Imbruvica group, according to results shared at the European Hematology Association 2021 virtual congress. At that time, 94.9% of Brukinsa takers were estimated to be alive without disease progression at one year, versus 84% in the Imbruvica arm, leading to a descriptive risk reduction of 60%.

In addition to efficacy, Brukinsa has previously demonstrated an advantage on cardiac toxicity, with a significantly lower rate of atrial fibrillation or flutter, which is a BTK classwide problem.

ALPINE represents the second head-to-head trial between Brukinsa and Imbruvica as part of BeiGene’s latecomer bid to challenge the market-leading Imbruvica. In the phase 3 ASPEN trial, Brukinsa narrowly missed its goal of beating Imburvica at shrinking tumors in Waldenstrom macroglobulinemia.

BeiGene has combined ALPINE and data from the phase 3 SEQUOIA trial in newly diagnosed CLL/SLL—though not head-to-head against Imbruvica—in a new application with the FDA. The application has a target action date of Jan. 20, 2023, which is the result of a three-month extension after BeiGene submitted additional tumor response data from ALPINE.

Together with AstraZeneca’s Calquence—which has its own Imbruvica head-to-head heart safety win—Brukinsa is already giving the market-leading blockbuster a run for its money. Imbruvica’s sales for J&J dropped 3.9% at constant currencies to reach $1.04 billion in the first quarter, and the decline widened to 7.2% in the second quarter, when the haul landed at $970 million. The company’s explanation was simple: Imbruvica suffered from “increased competition, particularly in the U.S.,” Jessica Moore, J&J’s vice president of investor relations, said on the company’s second-quarter earnings call in July.

On BeiGene’s side, Brukinsa sales increased 23% sequentially and reached nearly $129 million in the second quarter. Likely thanks to a positive NCCN guideline recommendation in January, including in front-line CLL/SLL, Brukinsa has seen some off-label CLL use in the U.S., SVB Securities analyst Andrew Berens, M.D., said in an August note, citing a BeiGene executive. The majority of Brukinsa’s growth is coming from new patient starts, with fewer switch patients from Imbruvica as Calquence takes away more share, the exec told the SVB team.