BeiGene tees up 3-way leukemia competition against J&J-AbbVie, AstraZeneca with Brukinsa win

With success from two trials, BeiGene could seek FDA approval for Brukinsa in both front-line and second-line chronic lymphocytic leukemia simultaneously. (BeiGene)

BeiGene’s Brukinsa is already approved in the small indication of mantle cell lymphoma. With a new trial win, the drug is on track to open up a much larger market.

Brukinsa outperformed the combination of bendamustine and rituximab at staving off cancer progression or death in newly diagnosed patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), BeiGene said Thursday.

Although detailed data from the phase 3 Sequoia trial remain under wraps, BeiGene characterized Brukinsa’s advantage as “highly statistically significant.” The win was for patients whose tumor didn’t have a resistance risk factor called del(17p).

The latest win adds onto Brukinsa’s recent success in previously treated CLL/SLL and puts it on a collision course with the other two BTK inhibitors in the key CLL battleground.

In a head-to-head phase 3 trial dubbed Alpine, Brukinsa showed it could trigger a significantly better response than AbbVie and Johnson & Johnson’s market-leading Imbruvica in patients with relapsed or refractory CLL/SLL. Plus, in an important safety win, patients who received BeiGene's drug were less likely to develop atrial fibrillation, or irregular heartbeat.

RELATED: EHA: Watch out, Imbruvica. BeiGene's touting Brukinsa efficacy, safety wins in a key leukemia battleground

Now, with pivotal data available from two trials, BeiGene could seek FDA nods for both front-line and second-line CLL simultaneously. When BeiGene unveiled the second-line win at the European Hematology Association’s virtual congress last month, Jane Huang, M.D., chief medical officer of hematology, told Fierce Pharma that “there may be opportunities” to file both sets of data in one FDA application.

The new data could support an approval and a favorable label, “thus positioning Brukinsa as a key BTK inhibitor in the CLL space, particularly if the asset continues to demonstrate differentiation that could translate into a commercial advantage,” SVB Leerink analyst Andrew Berens wrote in a Friday note.

As the first BTK inhibitor to hit the scene, Imbruvica owns the lion’s share of the market. In the first half of 2021, J&J collected $2.24 billion from Imbruvica global sales, while AbbVie reported $2.65 billion, including $551 million from profit sharing with J&J.

Meanwhile, AstraZeneca’s Calquence is catching up quickly with a first-half haul of $490 million thanks to 150% year-over-year growth. The majority, $445 million, came from the U.S.

RELATED: ASCO: AstraZeneca details Calquence's heart safety edge over Imbruvica as both brace for BeiGene's rival Brukinsa

Calquence’s growth suggests that Imbruvica’s first-mover advantage in CLL isn’t insurmountable, Berens said, adding that Brukinsa seems to have an even better profile than Calquence.

Still, Brukinsa is BeiGene’s first commercial drug in the U.S. Facing those Big Pharma companies with entrenched oncology presence won’t be cakewalk for the Chinese company. Brukinsa’s first-quarter sales came in at $22.1 million, mostly from China, where the drug has been allowed for relapsed or refractory CLL/SLL since last June.