Research & Development
BeiGene Receives Positive CHMP Opinion for Brukinsa for the Treatment of Adults with Marginal Zone Lymphoma
20 September 2022 - - The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending approval of Brukinsa (zanubrutinib) for the treatment of adult patients with marginal zone lymphoma who have received at least one prior anti-CD20-based therapy, China-based biotechnology company BeiGene (NASDAQ: BGNE) (HKEX: 06160) (SSE: 688235) said.

The CHMP recommendation is based on positive results from the Phase 2, open-label, multicenter, single-arm MAGNOLIA trial (NCT03846427) in 66 patients with relapsed or refractory MZL who received at least one anti-CD20-based regimen.

In the study, the overall response rate was 68% (95% CI: 55.6, 79.1) with 26% of patients achieving complete response and 42% achieving partial response.

The median time to response was 2.8 months (range: 1.7 to 11.1 months) and ORRs for MZL subtypes extranodal, nodal, splenic, and unknown were 64%, 76%, 67%, and 50%, respectively.

Brukinsa demonstrated favorable and well-defined tolerability consistent with its known safety profile.

The most common adverse reactions, including laboratory abnormalities, in the pooled safety population of 847 patients were decreased neutrophil count, upper respiratory tract infection, decreased platelet count, and hemorrhage.

The observed cardiac safety profile was consistent with previous Brukinsa studies, with low rates of atrial fibrillation and atrial flutter.

Brukinsa was well-tolerated, as demonstrated by low rates of discontinuation due to adverse events.

Following the CHMP positive opinion, the European Commission will consider BeiGene's Marketing Application, with a final decision expected within 67 days of the CHMP opinion.

The decision will be applicable to all 27 member states of the European Union plus Iceland and Norway.

Brukinsa is currently approved in the EU for the treatment of adult patients with Waldenström's macroglobulinemia who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy.

BeiGene has obtained reimbursement for Brukinsa for the treatment of Waldenström's macroglobulinemia in Austria, Belgium, Denmark, England and Wales, Germany, Ireland, Spain, and Switzerland while additional EU countries are currently going through the reimbursement process.

Marginal Zone Lymphoma is a group of ultra-rare, slow growing B-cell malignancies that begin in the marginal zones of lymph tissue.

Epidemiological data from Europe is limited, but the incidence rate of MZL is estimated to range between 20 and 30 per m per year.

There are three different subtypes of MZL: extranodal marginal zone B-cell lymphoma, or mucosa-associated lymphoid tissue, which is most common; nodal marginal zone B-cell lymphoma which develops in the lymph nodes and is rare; and splenic marginal zone B-cell lymphoma which develops in the spleen, bone marrow, or both, and is the rarest form of the disease.

Brukinsa is a small molecule inhibitor of Bruton's tyrosine kinase discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

Because new BTK is continuously synthesized, Brukinsa was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.

With differentiated pharmacokinetics compared to other approved BTK inhibitors, Brukinsa has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

Brukinsa is supported by a clinical program which includes more than 4,500 subjects in 35 trials across 28 markets.

To date, Brukinsa has received more than 20 approvals covering more than 50 countries and regions, including the United States, China, the EU, Great Britain, Canada, Australia, and additional international markets.

Currently, more than 40 additional regulatory submissions are in review around the world, the company said.
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