BeOne Medicines (ONC) JMP Hematology and Oncology Summit 2024 summary

Company overview and pipeline strategy

• Operates globally with 1,100 employees and two approved oncology medicines, Brukinsa (BTK inhibitor) and Tevimbra (PD-1 inhibitor).

• Maintains a large preclinical research team, aiming to bring 8–10 new molecular entities (NMEs) into the clinic annually.

• In 2024, advanced 10 NMEs into clinical trials, focusing on solid tumors (lung, GI, breast) and immunology.

• Pipeline includes CDK4 selective inhibitor, pan-KRAS inhibitor, and multiple ADCs targeting CEA, B7-H3, and B7-H4.

• Emphasizes modality-agnostic development, prioritizing tumor types and targets.

Brukinsa clinical data and market position

• Brukinsa is a best-in-class BTK inhibitor with five labels, including unique approval for follicular lymphoma, and is approved in over 70 countries.

• ALPINE study shows a 50% risk reduction in death/progression versus ibrutinib, with sustained PFS at 42.5 months follow-up.

• SEQUOIA study demonstrates durable PFS in frontline CLL, with efficacy maintained after 60 months, regardless of risk features.

• Safety profile is superior, with lower rates of cardiac events and atrial fibrillation compared to competitors.

• Patent protection remains strong, and Brukinsa is positioned as the leading BTK inhibitor in the U.S.

Upcoming data and pipeline highlights

• Key ASH presentations include long-term SEQUOIA follow-up and new data on Brukinsa’s efficacy and safety.

• BCL-2 inhibitor sonrotoclax shows deep, durable responses and high undetectable MRD rates in combination with Brukinsa.

• BTK degrader program has enrolled over 350 patients, with promising early efficacy and safety in CLL, Waldenström, and indolent lymphomas.

• Multiple phase 3 studies are underway or planned for BTK degrader and sonrotoclax in CLL and mantle cell lymphoma.

• Expansion cohorts and pivotal studies may lead to fast-track designations.