Perioperative tislelizumab improves survival in resectable NSCLC – a new standard of care?


Encouraging EFS and OS results were presented at an ESMO Virtual Plenary for the use of the immune checkpoint inhibitor prior and after surgery  

Perioperative use of the anti-PD-1 monoclonal antibody tislelizumab improves responses at the time of surgery and reduce the risk of disease recurrence in patients with early-stage resectable non-small cell lung cancer (NSCLC), as confirmed by updated results from the RATIONALE-315 (NCT04379635) presented at the ESMO Virtual Plenary in February 2024.

Although surgery is the most efficient frontline therapy for this tumour type, recurrence rates at 5-years are still unacceptably high, raising the need for more effective neoadjuvant and adjuvant strategies to improve the patients’ outcomes. In the Phase III RATIONALE-315 trial, the efficacy of tislelizumab prior and after surgery was assessed in 453 patients with treatment-naïve resectable stage II–IIIA NSCLC. Patients were randomised to receive either tislelizumab combined with platinum-doublet chemotherapy or a placebo plus chemotherapy in the neoadjuvant setting, and to receive tislelizumab monotherapy or a placebo as adjuvant treatment.

In the interim analysis, a clinically meaningful and statistically significant benefit in event-free survival (EFS) by blinded independent central review, the primary endpoint, in the tislelizumab group was observed at a median follow-up of 22 month (HR=0.56 [95% CI: 0.40, 0.79]; one-sided P=0.0003), and it was generally consistent across all predefined subgroups. The neoadjuvant combination therapy showed a statistically significant improvement in the second primary endpoint, major pathological response (MPR), with a difference of 41.1% between the two groups (95% CI: 33.2, 49.1; P<0.0001).

Encouraging data were also presented for the secondary endpoint, with overall survival (OS) benefit trend favouring perioperative tislelizumab (HR=0.62 [95% CI: 0.39, 0.98]; one-sided P=0.0193) and 40.7% of patients treated with the tislelizumab combination achieving pathological complete response (pCR) compared to 5.7% of patients in the chemotherapy plus placebo arm (35.0%; 95% CI: 27.9, 42.1; P<0.0001).

“The data presented at the ESMO Virtual Plenary confirms the role of tislelizumab as a perioperative strategy for patients with early-stage resectable NSCLC. The benefit in EFS was aligned even in magnitude with that of other PD-1 inhibitors”, says Luis Paz-Ares, Hospital Universitario 12 de Octubre, Madrid, Spain commenting on the study results which are consistent with those from a first interim analysis presented at the ESMO Congress 2023 (Ann Oncol. Volume 34, Supplement 2, S1299, Oct 2023). “The PD-1-based regimen could be considered as a novel standard option of care, particularly in Asia, but validation in Western patients would be welcome in the future.”


Figure. Improvement in Event-Free Survival reported in an interim analysis of the RATIONALE-315 study (ESMO Virtual Plenary, 15-16 February 2024, Abstract VP1-2024)

Abstract discussed

D. Yue et al. 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)​. (VP1-2024). ESMO Virtual Plenary, 15 February 2024.

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