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The ongoing phase I/Ib BGB-11417-101 trial (NCT04277637) is evaluating the safety and efficacy of sonrotoclax ± zanubrutinib ± obintuzumab, in patients with B-cell malignancies.1 Updated results from the cohort of patients with R/R MCL who received sonrotoclax + zanubrutinib (N = 51) were presented at the 2025 European Hematology Association (EHA) Congress by Raul Cordoba.1 |
Key learnings |
The safety profile was consistent across all sonrotoclax doses tested, with no DLTs, and the MTD was not reached up to sonrotoclax 640 mg; sonrotoclax 320 mg was chosen as the RP2D (any TEAEs, 96.3%; Grade ≥3 TEAEs, 51.9%). |
With a median follow-up of 16.4 months, the ORR and CR rate were 78% and 70%, respectively, in the sonrotoclax 320 mg + zanubrutinib group (n = 23). |
The median DoR in the sonrotoclax 320 mg + zanubrutinib group was not reached, with a 24-month DoR rate of 80.1%. |
Sonrotoclax + zanubrutinib had a tolerable safety profile and encouraging antitumor activity, with early, deep, and durable responses in patients with R/R MCL. This combination is being evaluated in the phase III CELESTIAL-RRMCL trial (NCT06742996), with enrollment currently ongoing. |
BCL-2i, B-cell lymphoma 2 inhibitor; BTKi, Bruton’s tyrosine kinase inhibitor; CR, complete remission; DLT, dose-limiting toxicity; DoR, duration of response; EHA, European Hematology Association; MCL, mantle cell lymphoma; MTD, maximum tolerated dose; ORR, overall response rate; RP2D, recommended phase II dose; R/R, relapsed/refractory; TEAE, treatment-emergent adverse event.
References
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