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BeiGene's Brukinsa wins CLL approval after outperforming Imbruvica in head-to-head test – Endpoints News

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The FDA has given the green light to BeiGene’s Brukinsa for use in chronic lymphocytic leukemia, an approval that is expected to substantially expand the market for the drug in the United States after it outperformed the current leading therapy in a trial.

The approval, which is for relapsed/refractory and first-line treatment for adults with CLL as well as small lymphocytic lymphoma, is the drug’s fourth release in the United States. This comes after BeiGene showed the twice-daily oral drug outperformed Johnson & Johnson’s standard of care, AbbVie and Imbruvica, in a head-to-head test.

“That’s what’s most important to BeiGene,” said Mehrdad Mobasher, who replaced Jane Huang last year as CMO of Hematology Biotechnology. What’s New About Endpoints before the FDA decision. “CLL is the most common leukemia in adults.”

BeiGene counts the decision as a crucial step in significantly expanding its US sales and helping the company realize its ambitions to expand further in cancer, as well as other areas. And while the data is solid, the company will face an entrenched competitor.

In the first three quarters of 2022, BeiGene accrued $388.5 million in global revenue for Brukinsa, according to financial reports. Imbruvica’s global net income was US$3.45 billion in the same period and Calquence generated US$1.46 billion in worldwide revenue in that nine-month period.

Imbruvica has been in business for nearly nine years and made impressive headlines for AbbVie’s $21 billion purchase of Pharmacyclics in 2015. AstraZeneca followed suit half a year later with a multi-billion dollar purchase of second-generation BTK inhibitor Calquence from Acerta , which was brought to the clinic by many of the leaders who spearheaded Imbruvica’s early investigation plans.

face to face judgment

Study investigator Jennifer Brown said that the safety of Brukinsa was also better than that of Imbruvica, including a lower rate of heart disorders. Brown, who is also director of the Dana-Farber Center for Chronic Lymphocytic Leukemia, told reporters at the American Society of Hematology meeting last month that she doesn’t think there is a group of patients with CLL for whom Imbruvica would remain the standard .

In the ALPINE study of nearly 650 patients, the progression-free survival rate was 79.5% for patients receiving BeiGene and 67.3% for those receiving Imbruvica at 24 months. In the relapsing/refractory setting, BeiGene said that 80.4% of patients in Brukinsa responded, versus 72.9% in Imbruvica, with a p-value of 0.0264.

In a different Phase III trial, dubbed SEQUOIA, BeiGene showed that Brukinsa led to better progression-free survival than the combination of the cancer drugs bendamustine and Rituxan.

Brukinsa won its first FDA win in November 2019 for patients with the rare and aggressive blood cancer known as mantle cell lymphoma. Another nod came in August 2021 for a rare form of lymphoma known as Waldenström’s macroglobulinemia, despite Brukinsa failing in the head-to-head against Imbruvica.

A month later, in September 2021, the FDA expanded the label to include adult patients with relapsed or refractory marginal zone lymphoma (MZL) who received at least one anti-CD20-based regimen.

Mehrdad Mobasher

It’s good for an elderly population to have “more medications and more tolerable treatments,” he added.

The National Comprehensive Cancer Network has also shown its preference for Brukinsa in recent months, ahead of the expanded label, updating its guidelines to recommend that doctors choose the drug over Imbruvica for the treatment of CLL.

The European Commission approved the drug for CLL in November. Overall, Brukinsa is approved in more than 60 markets and has been studied in more than 30 clinical trials, BeiGene said.

company ambitions

“Most of our time is spent looking at oncology because this is our strength,” Beigene CEO John Oyler told Endpoints at the JP Morgan health conference in San Francisco earlier this month. “We’re starting to look at other areas that are tangential to this one and other things we could do to leverage some of the infrastructure that we have.”

About 20,000 new cases of the specific lymphoma were expected in 2022, according to Dana-Farber. CLL is when cancer cells populate the bone marrow and bloodstream, whereas with small lymphocytic the cancer occurs primarily in the lymph nodes.

Brukinsa and Imbruvica are covalent inhibitors of Bruton’s tyrosine kinase, which aim to block a protein that helps send signals that drive the growth of leukemia and lymphoma cells. If the protein’s signal is blocked in B cells, the cancer cells should be eliminated, the researchers believe. But Imbruvica has been shown to have off-target effects, meaning it harms not just the BTK protein.

The next generation of BTK inhibitors, those that don’t covalently bind, could hit the market soon. Earlier this year, the FDA is expected to decide whether to approve Eli Lilly’s pirtobrutinib in patients with mantle cell lymphoma pretreated with BTK.

Paul Schloesser contributed reports.

Editor’s note: CLL is an abbreviation for chronic lymphocytic leukemia, not lymphoma.