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BeiGene (BGNE) Brukinsa Superior to Imbruvica in Leukemia Study

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BeiGene, Ltd. BGNE announced that the phase III study — ALPINE — evaluating its BTK inhibitor drug, Brukinsa (zanubrutinib), for treating relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), met its primary endpoint of superiority compared to AbbVie’s ABBV popular cancer drug, Imbruvica (ibrutinib).

Per the final response data from the ALPINE study, as assessed by an Independent Review Committee (IRC), Brukinsa demonstrated superiority over AbbVie’s Imbruvica in treating R/R CLL or SLL patients, measured by objective response rate (“ORR”). Data from the study, as determined by the IRC, showed that Brukinsa achieved an ORR of 80.4% versus 72.9% for AbbVie’s Imbruvica. The response data were based on patients in the study who were followed for a median of 24.2 months.

Data from a previously completed interim analysis of the ALPINE data had demonstrated that Brukinsa was superior to AbbVie’s Imbruvica as measured by the investigator-assessed overall response rate.

BeiGene also stated that the safety profile of Brukinsa was consistent with previous studies. The safety profile of Brukinsa seemed to be better than AbbVie’s Imbruvica. In a pre-specified safety analysis following a follow-up of a median of 24.2 months, the rate of atrial fibrillation or flutter was 4.6% for Brukinsa compared to 12% for AbbVie’s Imbruvica. Moreover, 13% of patients in the Brukinsa arm discontinued treatment due to adverse events compared to 17.6% for patients receiving Imbruvica. However, the occurrence of most commonly reported grade 3 or higher adverse events was lower for Brukinsa for pneumonia compared to Imbruvica. In contrast, neutropenia, hypertension, decreased neutrophil count and COVID-19 pneumonia were higher in the Brukinsa arm.

The ALPINE study will continue to follow up patients for measuring progression-free survival (“PFS”) as the final analysis of the study. The potential superiority of Brukinsa over Imbruvica in PFS, coupled with the ORR superiority, will boost the prospect of the drug to receive an FDA approval for treating R/R CLL or SLL.

Shares of BeiGene have declined 31.9% so far this year compared with the industry’s decrease of 12%.

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BeiGene’s Brukinsa was first approved in 2019 for treating mantle cell lymphoma (“MCL”) followed by label expansion to include Waldenström’s macroglobulinemia (“WM”) and marginal zone lymphoma (“MZL”) in 2021.

We note that AbbVie’s Imbruvica is an FDA-approved therapy for treating R/R CLL or SLL. The drug is also approved for treating WM and MZL. BeiGene’s Brukinsa is likely to provide good competition to AbbVie’s Imbruvica going forward as both drugs target similar indications.

Apart from Brukinsa, BeiGene has an anti-PD-1 antibody drug in its portfolio, tislelizumab, which is currently approved in China only. Tislelizumab is available in China for treating advanced squamous non-small cell lung cancer, classical Hodgkin’s lymphoma and locally advanced or metastatic urothelial carcinoma with PD-L1 high expression. BeiGene is seeking approval for the drug as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma in the United States. A decision from the FDA is expected on Jul 12, 2022.

BeiGene’s promising oncology candidates and drugs and its presence in a growing market like China have attracted big pharma companies including Amgen AMGN and Novartis NVS for partnerships.

In 2021, Novartis signed two agreements to gain rights to BeiGene’s pipeline candidates. Novartis signed a strategic collaboration agreement for in-licensing BeiGene’s tislelizumab in major markets outside of China. Novartis inked an option, collaboration and license agreement with BeiGene to obtain the development and commercialization rights to TIGIT inhibitor, ociperlimab, in the United States, Europe and a few other countries.

Amgen and BeiGene had signed an oncology collaboration agreement in 2019. Amgen also made an investment of approximately $421 million in BeiGene in 2020. The company believes that the oncology collaboration is likely to generate enough potential for the company in China.

BeiGene, Ltd. Price

BeiGene, Ltd. Price
BeiGene, Ltd. Price

BeiGene, Ltd. price | BeiGene, Ltd. Quote

Zacks Rank

BeiGene currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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