EU Approves TEVIMBRA for NSCLC Before WCLC 2025 Data Reveal

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

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).

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