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Aiming to establish itself as a standard-bearer in blood cancer treatment, BeiGene is taking on some of the biggest hits in the field with its next-generation BTK inhibitor, Brukinsa, and building a vibrant hematology franchise that can grow from there.
Brukinsa, the first drug approved by the FDA in 2019 to treat mantle cell lymphoma, was the result of an intense research effort to improve on AbbVie and Johnson & Johnson’s Ibruvica and AstraZeneca’s Calquence, said Dr. Mehrdad Mobasher, chief medical officer of hematology at BeiGene.
“From the beginning, we designed Brukinsa to succeed where other BTK inhibitors have not.”
Mehrdad Mobashir
Chief Medical Officer, Hematology, BeiGene
The pipeline is also expanding with four more approvals for its flagship franchise drugs, including the BCL2 inhibitor sonlotoclax, which is currently in late-stage research in chronic lymphocytic leukemia alongside Brukinsa, and a new treatment called BTK degrader that aims to permanently destroy the disease-causing protein that Brukinsa inhibits.
Increased competition in the hematology field and safety concerns have weighed on Ibrubica sales, Last year it fell by about 20%Brukinsa and Calquence continue to perform well. Global sales of Brukinsa soared last year. 129% increase to $1.3 billion On the other hand, Calquence Revenue: $2.5 billion — 22% increase.
Here, Mobasher discusses the approach BeiGene is taking to build out its hematology franchise in a way that solidifies the company’s position in the blood cancer field and brings new therapies to an area with enormous unmet need.
This interview has been edited for clarity and style.
PHARMAVOICE: What will it take to shape your hematology portfolio to address unmet needs and establish a direction for you to head in the long term?
Dr. Mehrdat Mobasher: Our approach is very research-driven. We have over 1,000 researchers who understand the biology and develop cutting-edge models and processes for how to discover new drugs and develop targets. With this large research group, there are many targets. Brukinsa, a BTK inhibitor, is an example of how we continue to deliver best-in-class and first-in-class drugs. Sometimes there are better drugs out there, which means you can treat patients with the same target in a better way.
Often franchises such as hematology and solid tumors can be siloed at larger companies, so how does BeiGene connect these pipelines to a unified goal?
The short answer is, we call it the BeiGene pipeline. We don’t call it a solid tumor pipeline or a hematology pipeline. I primarily oversee asset development in hematological malignancies, which is my background. We have Dr. Mark LaNasa (Chief Medical Officer) in solid tumors, and we share agents. The two organizations work very closely together, but each has distinct roles and responsibilities for the diseases they oversee.
What is the history of the BTK inhibitor class and how BeiGene became involved in this space with the introduction of Brukinsa?
From the beginning, we intentionally designed Brukinsa to succeed where other BTK inhibitors have not. BTK inhibitors are known and have been on the market for some time. In fact, they have revolutionized the treatment of many B-cell malignancies. What BTK inhibitors do is block what’s called B-cell receptor signaling, which is important for maintaining healthy, normal cells. If we control this signaling pathway, we can control the survival of malignant cells and put them to sleep. This is what we aim to do.
The first generation of BRK inhibitors (AbbVie and Johnson & Johnson’s Ibruvica) was a very important step forward in the therapeutic field, and the second generation (AstraZeneca’s Calquence) has improved safety.
The next generation is Brukinsa, which was designed by understanding the science and optimizing how we approach this target. Brukinsa was designed to be more potent and highly selective for BTK to avoid off-target inhibition and toxicity. And the extensive development plan allows Brukinsa to succeed where other BTK inhibitors have not been as successful.
How did you approach developing and scaling Brukinsa to differentiate it from other products in its class?
The broad development plan that we took with Brukinsa ultimately led to five indications in the U.S., including accelerated approvals for mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma; the other two are chronic lymphocytic leukemia and Waldenstrom’s macroglobulinemia. It’s the only BTK inhibitor with this broad indication, and part of that bold plan was to go head-to-head with a breakthrough BTK inhibitor in CLL patients, Imbruvica, and show efficacy and safety advantages. It’s the only agent that’s ever done that. By taking on a large, broad, and bold head-to-head study, we’re able to show deep and durable responses.
You mentioned that BeiGene’s approach allows you to take a known pathway and improve on it, but how does that happen?
When we look at the science, we see the need for the target and the molecule and how to improve it. If you look at the names of our assets, you will see a number behind them, which indicates how many drugs were initially tested before this drug was launched. We are working with an understanding of the treatment landscape, the evolution of treatments and the unmet needs. We want to cover the patient’s journey until we cure these symptomatic malignancies. In the future, you will see more combinations of our own assets and with important drugs manufactured by other companies. You will also see more drugs coming into our hematology pipeline in the near future.
