The FDA has recently granted expanded approval for BeiGene’s oral Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for patients with chronic lymphocytic leukemia (CLL) or small Lymphocytic Leukemia (SLL). Brukinsa has gained approval after outperforming Abbvie’s Imbruvica, which has been the standard of care in CLL for almost a decade. Brukinsa should largely replace Imbruvica as the preferred regimen and will more often be used as a treatment for patients who’ve relapsed, according to GlobalData, a leading data and analytics company.

In the Phase III ALPINE study, Brukinsa showed superior progression-free survival (hazard ratio [HR]: .65) and a significantly lower incidence of cardiovascular adverse events compared to Imbruvica.

Israel Stern, MSc, Oncology & Hematology Analyst at GlobalData, comments: “Chemotherapy regimens have historically been prescribed by physicians for patients with CLL/SLL. For the past decade the standard of care shifted to targeted therapies with the arrival of the small molecule inhibitor Imbruvica. Brukinsa, an upgraded version of Imbruvica, is a 2nd generation BTKi and more selective than Imbruvica leading to better safety and efficacy as evidenced in the ALPINE study.”

Imbruvica has seen its sales drop precipitously. In Q3 2022 it earned $1.14 billion in net revenue but that is a 17% drop from the same period in 2021. These figures should continue to decrease due to competition. On the other hand, BeiGene’s net sales from Brukinsa rose to $156 million in Q3 2022, up from $66 million for the same period in 2021. These figures are expected to increase significantly as it takes market share from Imbruvica.

Stern continues: “Although Brukinsa only recently gained expanded approval for CLL/SLL, doctors have been prescribing it off-label for several years. A challenge facing BeiGene is that another 2nd generation BTKi, AstraZeneca‘s Calquence  was first-to-market as it gained regulatory approval in November of 2019. A trial where the two drugs go head-to-head could go a long way into predicting future market capture.”

BeiGene’s research into CLL/SLL treatments does not end with Brukinsa. The Chinese company is currently developing BGB-11417, a BCL-2 inhibitor, an alternative targeted therapy for this indication.

Stern Concludes: “Preliminary data from a Phase l trial for BGB-11417 alone or in combination with Brukinsa have been encouraging. BCL-2 inhibitors, specifically Abbvie and Roche’s Venclexta  is a standard of care treatment for CLL/SLL. If approved, the combination of these targeted therapies may lead to the best outcomes for patients and even stronger sales for BeiGene.

“The Chinese company is all in on CLL, an indolent B-Cell malignancy the most common adult leukemia in the US, with approximately 20,000 new cases expected to be diagnosed in 2023. If they are successful, it will have a significant impact on its bottom line; thus far, it is working.”