Chinese pharma company BeiGene has revealed new data for its BTK inhibitor Brukinsa in a head-to-head trial against AbbVie and Johnson & Johnson’s rival drug Imbruvica.
The ALPINE trial is comparing Brukinsa (zanubrutinib) to Imbruvica (ibrutinib) in adult patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The results from an interim analysis of the trial, presented at the European Hematology Association 2021 (EHA2021) virtual congress, were based on the first 415 patient enrolled in the study.
Of these patients, 207 were on Brukinsa treatment and 208 were on Imbruvica treatment.
With a median follow-up time of 15.3 months, the trial met the primary endpoint with Brukinsa demonstrating superior overall response rates (ORR), defined as the combined rate of complete responses (CR) and partial responses (PR).
As investigated by the trial investigator, Brukinsa achieved an ORR of 78.3% – reflecting a statistically significant improvement compared to a rate of 62.5% with Imbruvica treatment.
In the ORR analysis conducted by the independent review committee (IRC), BeiGene’s drug demonstrated non-inferiority in the interim analysis.
When assessed by the IRC, Brukinsa achieved an ORR of 76.3%, numerically higher although not statistically significant compared to 64.4% for Imbruvica treatment.
On a specific biomarker – patients with tumours exhibiting chromosome 17p deletion – the ORR was 83.3% in the Brukinsa arm, compared to 53.8% in the Imbruvica arm.
BeiGene said that the progression-free survival data was not available at the time of the interim analysis, adding that a formal analysis will be carried out when the target number of events are achieved.
At 12 months, the PFS rate was 94.9% in the Brukinsa arm, compared to 84.0% in the Imbruvica arm.
In addition, the overall survival (OS) data was also immature at the time of the analysis, although at 12 months the OS rate was 97% in the Brukinsa arm compared to 92.7% in the Imbruvica arm.
“As evidenced in ALPINE and ASPEN, our head-to-head trials of Brukinsa against the first-generation BTK inhibitor [Imbruvica], this potentially best-in-class molecule can provide meaningful responses and consistent safety advantages for these patients,” said Jane Huang, chief medical officer, Haematology at BeiGene.
“In addition to ALPINE, we are evaluating Brukinsa in the phase 3 SEQUOIA trial in treatment-naïve CLL, and expect to share topline results as early as later this year,” she added.