BeiGene saw huge growth in its BTK inhibitor Brukinsa this quarter, marking a 139% increase from the same time last year and a 46% increase from the first quarter.
Brukinsa brought in $308 million this quarter, driving the company’s 82% increase in total product revenue — $554 million — compared to this time last year.
The Brukinsa growth stems from several label expansions and approvals globally this year with the launch of the drug for the treatment of adult patients with chronic lymphocytic leukemia (CLL) in the US, along with approvals for expanded indications in China, Australia and Canada.
US sales alone for Brukinsa totaled $233.5 million this quarter, over 150% growth from 2022 “as adoption for adult patients with CLL/SLL accelerated and use across all FDA-approved indications continued to expand,” BeiGene said in a press release. China sales totaled $48.5 million, showcasing a 32.2% growth.
Meanwhile, Brukinsa’s competitor and current standard-of-care for CLL, Imbruvica by Abbvie and J&J, posted a 20% decline to $907 million this quarter.
BeiGene put Brukinsa and Imbruvica head-to-head in its Phase III ALPINE trial, showing that BeiGene’s contender beat Imbruvica on metrics in progression-free survival and safety in patients with relapsed/refractory CLL or small lymphocytic lymphoma.
“As demonstrated by the growing prescriber use for patients with CLL, Brukinsa is becoming the BTK inhibitor of choice, driven by compelling efficacy and safety data across indications, including superiority versus Imbruvica in relapsed/refractory (R/R) CLL,” BeiGene co-founder, chairman and CEO John Oyler said in a statement.
Brukinsa is making headway in other indications in the US. The FDA accepted an sNDA for the drug in combination with Gazyva (obinutuzumab) as a treatment for patients with relapsed/refractory follicular lymphoma with a PDUFA date in the first quarter of 2024.
BeiGene also credited part of its success this quarter to its monoclonal antibody tislelizumab for advanced solid tumors, which received a positive opinion from the CHMP of the European Medicines Agency as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after chemo.
The drug brought in $149.5 million in China for this quarter — a growth of 42.5% compared to last year — thanks to new patient demand and expansion of BeiGene’s “salesforce efficiency and hospital listings.” It had new approvals in China for the treatment of first-line gastric cancer and first-line ESCC.
Approvals in the US for the antibody are slower in the US, however, and may never come.
BeiGene announced this July that the FDA had completed its manufacturing inspection for the drug and the application was finally moving forward after a year-long delay because the FDA couldn’t complete the inspection due to Covid-related travel restrictions. If tislelizumab wins approval in the US, it would become the first checkpoint inhibitor initially developed in China to enter the US market.
BeiGene is partnered with Novartis on the drug and submitted an application for second-line ESCC. Novartis has rights to it in the US, Europe and Japan. A Novartis spokesperson for the company told Endpoints News that Novartis is planning for upcoming filings for tislelizumab in first-line ESCC and first-line gastric cancer in the US and EU. Timing is still being worked out with regulatory bodies.
The spokesperson added that the company decided last July not to submit the drug as a monotherapy in locally advanced or metastatic non-small cell lung cancer “based on regulatory feedback regarding IO therapies available in the US and the evolving treatment landscape.”
