European Commission Approves TEVIMBRA® as Neoadjuvant/Adjuvant NSCLC Treatment Ahead of Late-Breaking Data Presentation at WCLC 2025

Final analysis of RATIONALE-315 demonstrates clear overall survival benefit in perioperative setting in resectable non-small cell lung cancer

Broad EU label with nine approved indications in solid tumors, including five in lung cancer, highlights TEVIMBRA’s therapeutic range and strong clinical profile throughout the care continuum

SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved TEVIMBRA (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by TEVIMBRA monotherapy as adjuvant treatment, for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. The EC approval is based on results from the Phase 3 RATIONALE-315 trial. The preplanned final analysis of RATIONALE-315 demonstrates that TEVIMBRA, combined with platinum-based chemotherapy before surgery and continued as monotherapy afterward, showed statistically significant and clinically meaningful benefit in overall survival (OS) compared with chemotherapy combined with placebo. Data from this trial will be presented as a Late-Breaking Abstract (#MA04.08)¹ at the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain, September 6-9, 2025.

“Delivering a statistically significant overall survival benefit – a critical endpoint in oncology studies – alongside the European Commission’s approval of TEVIMBRA in perioperative resectable NSCLC marks a pivotal moment for patients and physicians,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. “As only the second PD-1 inhibitor to demonstrate an OS benefit in this setting, TEVIMBRA is poised to reshape lung cancer treatment in Europe.”

Building on the RATIONALE-315 results previously reported at the European Society for Medical Oncology (ESMO) Congress Virtual Plenary in February 2024² and published in The Lancet Respiratory Medicine³, which showed the dual primary endpoints of event-free survival (EFS) and major pathologic response (MPR) were met at the interim analyses, key findings from the final analysis (n=453 patients; randomized 1:1) include:

• With a median trial follow-up of 38.5 months, the TEVIMBRA-based regimen showed a statistically significant and clinically meaningful benefit in OS versus the chemotherapy + placebo arm (HR=0.65 [95% CI: 0.45, 0.93]; one-sided P=0.0093).
• The significant EFS benefit previously reported with TEVIMBRA versus chemotherapy + placebo was sustained in this analysis (HR=0.58 [95% CI: 0.43, 0.79]), and this improvement was consistent across both independent review committee (IRC) and investigator assessments, reinforcing the consistency and robustness of the findings.
• OS and EFS benefits were observed across major sub-groups, regardless of PD-L1 expression, disease stage, and histology.
• As reported at the interim analyses, the trial showed a clinically meaningful and statistically significant improvement in EFS, MPR and pathological complete response (pCR) vs. chemotherapy + placebo.
• The safety profile was consistent with the treatment components and the interim analyses. No new safety signals were identified, and the most common (≥ 10%) Grade 3 or 4 treatment-related adverse events (TRAEs) in both arms were decreased neutrophil count and decreased white blood cell count.

“Patients with resectable non-small cell lung cancer still face alarmingly high recurrence rates,” said Dr. Mariano Provencio, Head of the Medical Oncology Department at Hospital Universitario Puerta de Hierro and Professor at Universidad Autónoma de Madrid. “The RATIONALE-315 results confirm that starting tislelizumab in the neoadjuvant phase, and continuing after surgery, has proven to be a powerful approach to improve outcomes for these patients. Now, with approval in the EU, we have a clinically validated new treatment option in the perioperative setting.”

In lung cancer, TEVIMBRA is already approved in the EU in four indications:

• first-line treatment of patients with squamous NSCLC;
• first-line treatment of patients with non-squamous NSCLC with PD-L1 high expression;
• treatment of patients with locally advanced or metastatic NSCLC after prior platinum-based therapy; and
• first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).

It is also approved in the EU in the following indications:

• first-line treatment for patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma;
• first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC);
• second-line treatment in ESCC after prior platinum-based chemotherapy; and
• first-line treatment for patients with nasopharyngeal carcinoma (NPC).

About NSCLC

Lung cancer is the most commonly diagnosed type of cancer and the leading cause of cancer-related death worldwide.⁴ In Europe, lung cancer is the third most frequent cancer, with 484,306 new cases diagnosed in 2022.⁵ NSCLC accounts for 80–90% of all lung cancers⁶, of which resectable NSCLC patients at diagnosis represent around 25–30%⁷.

About RATIONALE-315

RATIONALE-315 (NCT04379635) is a randomized (1:1), double-blind, placebo-controlled, multicenter, Phase 3 trial, which evaluated TEVIMBRA neoadjuvant/adjuvant treatment in 453 adult patients with previously untreated, resectable, stage II or IIIA NSCLC. The dual primary endpoints are event-free survival (EFS) and major pathologic response (MPR). Key secondary endpoints include overall survival (OS), pathologic complete response (pCR), and disease-free survival (DFS).

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 more than 20 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 ability of TEVIMBRA to improve patient outcome and potentially alter the course of the disease and to potentially help patients earlier in their treatment journey; the impact of TEVIMBRA on lung cancer treatment in Europe; the ability of BeOne to deliver more comprehensive and effective cancer treatment to more patients; 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.

To access BeOne media resources, please visit our Newsroom site.

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1 Yue D, Wang W, Liu H, et al. Perioperative tislelizumab for resectable non-small cell lung cancer: final analysis of RATIONALE-315. IASLC 2025 World Conference on Lung Cancer (WCLC), September 2025. https://cattendee.abstractsonline.com/meeting/21151/Session/203

2 Yue D, Wang W, Liu H, et al. VP1-2024: RATIONALE-315: Event-free survival (EFS) and overall survival (OS) of neoadjuvant tislelizumab (TIS) plus chemotherapy (CT) with adjuvant TIS in resectable non-small cell lung cancer (NSCLC). Ann Oncol. 2024;35(3):332-223. https://www.annalsofoncology.org/article/S0923-7534(24)00012-7/fulltext

3 Yue D, Wang W, Liu H, et al; Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomized clinical trial. Lancet Respir Med. 2025;13(2):119-129. https://www.sciencedirect.com/science/article/abs/pii/S2213260024002698?via%3Dihub

4 Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2022;74(3):229-263. doi:10.3322/caac.21834. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834

5 Ferlay J, Ervik M, Lam F, et al, Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer; 2024. https://gco.iarc.who.int/media/globocan/factsheets/populations/908-europe-fact-sheet.pdf.

6 European Society of Medical Oncology. Non-small-cell lung cancer: A guide for patients. ESMO website. https://www.esmo.org/for-patients/patient-guides/non-small-cell-lung-cancer

7 Isla D, Majem M. A paradigm shift for resectable non-small cell lung cancer. Arch Bronconeumol. 2022;58(12):792-793. https://www.archbronconeumol.org/en-a-paradigm-shift-for-resectable-articulo-S030028962200326X

 

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