BeiGene, Ltd. announced the presentation of new data across a range of assets and blood cancers at the upcoming 65thAmerican Society of Hematology (ASH) Annual Meeting and Exposition, taking place December 9-12 in San Diego, California. BeiGene has 24 abstracts accepted at ASH, with three abstracts scheduled for oral presentations. Furthering Leadership in BTK Inhibition with BRUKINSA: BRUKINSA continues to show sustained PFS benefit versus ibrutinib in the global Phase 3 ALPINE trial of patients with R/R CLL/SLL with this longer follow up.
Durable PFS was observed across major subgroups, including in the high-risk 17p deletion/TP53 mutated patient population. In addition, the overall safety and tolerability profile was consistent with previous ALPINE analyses, including persistently lower rates of cardiovascular events reported with BRUKINSA. Based on these results among patients receiving more than three years of treatment, BRUKINSA continues to be a more efficacious and better-tolerated treatment than ibrutinib for patients with R/R CLL/SLL.
(Abstract #202, oral presentation). Data from Waldenström Macroglobulinemia patients treated with and tolerating ibrutinib on the Phase 3 ASPEN trial who switched to receive BRUKINSA on a long-term extension study demonstrate generally improved safety and deepening of responses with the switch to BRUKINSA. (Abstract #3043).
In an ongoing Phase 2 study, patients with B-cell malignancies experiencing intolerance to acalabrutinib were transitioned to BRUKINSA, with favorable results. The data suggest that for patients intolerant of acalabrutinib, switching to BRUKINSA leads to better tolerance (rare recurrence of adverse events) while maintaining or deepening response. (Abstract #3279).
Advancing BeiGene?s Pipeline of Next-Generation Blood Cancer Treatments: In an ongoing Phase 1/2 study, patients with treatment-naïve (TN) CLL/SLL were treated with sonrotoclax in combination with BRUKINSA. The combination was observed to be well tolerated; no cases of tumor lysis syndrome (TLS) were observed. There was a 100% response rate, including deep responses, and at time of follow-up no patient experienced disease progression (100% PFS).
(Abstract #327, oral presentation) Based on these results, a Phase 3 study assessing a fixed duration combination of sonrotoclax and BRUKINSA is planned. Sonrotoclax has also been well tolerated with high response rates as monotherapy in a continuing Phase 1 study in patients with R/R marginal zone lymphoma (MZL). (Abstract #3032).
Sonrotoclax was also evaluated in combination with dexamethasone in patients with R/R multiple myeloma (MM) harboring t(11;14) at doses up to 640 mg. Promising initial data indicate the combination is safe and efficacious, with the majority of patients across all dose levels achieving clinical response, including deep responses. Further investigations in this setting are ongoing.
The US Food and Drug Administration recently granted Orphan Drug Designation to sonrotoclax for treatment of multiple myeloma. (Abstract #1011, oral presentation). The first presentation of data from an ongoing, first-in-human study of BeiGene?s novel, orally available BTK-targeted chimeric degradation activation compound (CDAC), BGB-16673, demonstrates a tolerable safety profile and notable clinical responses that are durable at this clinical cut off in heavily pretreated patients with B-cell malignancies, including those with BTKi-resistant disease.