As BeiGene sets the stage for a pivotal showdown with the OG BTK inhibitor Imbruvica, its zeroing in on a subset of patients for whom their drug, zanubrutinib, could be especially helpful.
The Chinese biotech also brandished the latest mid-stage results for its PD-1 drug visilizumab, another franchise shaker thats under priority review in China, at the EHA Congress.
Investigators took a data cut from a Phase III open-label trial that is putting zanubrutinib against Imbruvica (ibrutinib) in patients with Waldenstrms Macroglobulinemia to showcase promising response rates. A non-randomized cohort of 26 patients, who has the MYD88WT genotype of WM, all received zanubrutinib. Five of them were treatment-nave while the others had relapsed/refractory disease.
For these patients, who typically have poorer prognoses with lower response rates, we recognize the real need for a highly potent and selective BTK inhibitor that can sustain BTK inhibition and reduce off-target effects, CMO Jane Huang said in a statement.
At a median follow-up of 12.2 months, the drug scored an overall response rate of 80.8%, with 53.8% of patients experiencing a partial response or better. The very good partial response rate was 23.1% while exactly one patient achieved a complete response.
Imbruvica was first approved in 2015 as a monotherapy for WM, a rare, slow-growing and incurable form of non-Hodgkin lymphoma. A combination with Rituxan was also OKd last year based on progression-free survival results. The hazard ratio compared to Rituxan alone was an impressive 0.20 (p
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