BeOne Medicines Presents New Data on TEVIMBRA in Lung Cancer at ESMO 2025

New data from two pivotal TEVIMBRA studies – RATIONALE-307 and -312 – reinforce the PD-1 inhibitor's proven clinical benefit in both NSCLC and ES-SCLC

Early data from investigational HPK1 inhibitor BGB-26808, in combination with TEVIMBRA, show promise in advanced solid tumors

BeOne Medicines Ltd. (NASDAQ:ONC, HKEX: 06160, SSE: 688235)), a global oncology company, today announced the presentation of data from two pivotal Phase 3 trials – RATIONALE-307 and 312 – offering new evidence of the benefits of its PD-1 inhibitor, TEVIMBRA^® (tislelizumab), at the European Society of Medical Oncology 2025 Congress (ESMO 2025) in Berlin, Germany, October 17-21. The results reinforce TEVIMBRA's consistent and durable efficacy across lung cancer subtypes, including non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer (ES-SCLC). In addition, the first clinical data from BeOne's investigational HPK1 inhibitor, BGB-26808, as a single agent and in combination with TEVIMBRA, will be presented, highlighting promising antitumor activity and a generally manageable safety and tolerability profile in patients with advanced solid tumors.

"The results presented at ESMO 2025 strengthen the evidence base for TEVIMBRA in lung cancer, with consistent survival benefit across subtypes. We're also encouraged by clinical activity from our investigational HPK1 inhibitor, BGB-26808, which supports our TEVIMBRA-based combination strategy," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. "With TEVIMBRA's recent European approval in perioperative resectable NSCLC and our diversified, combination-rich pipeline, we are advancing next-generation options for people with lung cancer."

New Data Builds on Strong Evidence Base for TEVIMBRA in Lung Cancer Treatment

The European Commission's approvals of TEVIMBRA in lung cancer are based on five randomized Phase 3 studies from the RATIONALE program. At ESMO 2025, BeOne will present new data from two of these trials, further substantiating TEVIMBRA's efficacy across lung cancer settings, including NSCLC and ES-SCLC, with a consistent safety profile.

• RATIONALE-307 (NCT03594747): Long-term data show TEVIMBRA plus chemotherapy significantly improved overall survival over chemotherapy alone across different subgroups of patients with locally advanced or metastatic squamous NSCLC, including patients with stage IV disease, irrespective of PD-L1 expression. These survival benefits were observed even in the presence of high in-study crossover from chemotherapy to TEVIMBRA, a factor that typically reduces the observed benefit of treatment¹. TEVIMBRA plus chemotherapy demonstrated a generally well-tolerated safety profile with no new safety signals even at the longer follow-up. The most common Grade 3 or 4 treatment-related adverse events (TRAEs) were associated with chemotherapy and included decreased neutrophil counts, neutropenia and leukopenia. (poster #1858, Oct. 18, 12:00-12:45 PM CEST).
  
  
  
  A post-progression analysis from RATIONALE-307 also suggests that continued TEVIMBRA monotherapy may help extend survival in select patients whose disease progresses in a slower, more localized way (poster #1871​, Oct. 18, 12:00-12:45 PM CEST).

• RATIONALE-312 (NCT04005716): Three-year data confirmed long-term efficacy and safety of first-line TEVIMBRA plus chemotherapy in ES-SCLC, with meaningful and sustained improvements in overall survival in both the intent-to-treat population and PD-L1-expressing subgroups, and no new safety signals identified. The most common Grade 3 or 4 TRAEs for TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, thrombocytopenia, and decreased white blood count (poster #2765, Oct. 18, 12:00-12:45 PM CEST).

Pipeline Momentum: Early Findings from HPK1 Inhibitor BGB-26808

Preliminary findings from the Phase 1a dose-escalation trial (NCT05981703) assessing BGB-26808, a novel, second-generation HPK1 inhibitor, as monotherapy and combined with TEVIMBRA showed encouraging antitumor activity in the combination arm. The combination arm achieved an unconfirmed objective response rate (ORR) of 15.4%, including one complete response and seven partial responses. Safety was manageable in patients with advanced, metastatic, and unresectable solid tumors. Grade 3 or 4 TRAEs with single-agent BGB-26808 were reported in 21.8% of patients and in 21.2% of patients in the combination arm (poster #1564, Oct. 19, 12:00-12:45 PM CEST).

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body's immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne's solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 22 registration-enabling studies. TEVIMBRA is approved in 47 markets, and more than 1.7 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

The information in this press release is intended for a global audience. Product indications vary by region.

About BeOne Medicines

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the potential benefits of TEVIMBRA across lung cancer subtypes; the potential benefits of BGB-26808 in combination with TEVIMBRA in patients with advanced solid tumors; the ability of BeOne to advance next-generation options for people with lung cancer; and BeOne's plans, commitments, aspirations, and goals under the heading "About BeOne Medicines." Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled "Risk Factors" in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

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