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BeiGene Announces the Phase 3 RATIONALE 315 Trial Met Primary Endpoints of Major Pathological Response Rate and Event-Free Survival for Tislelizumab Plus Chemotherapy in Patients with Resectable Non-Small Cell Lung Cancer (NSCLC)

Published: 2023-10-17 20:01:00 ET

Late-breaking ESMO data show 56.2% of patients with resectable NSCLC who received tislelizumab plus chemotherapy before surgery achieved major pathological response, versus 15.0% of those treated with neoadjuvant chemotherapy alone
Analysis also found 40.7% of patients on the tislelizumab-based regimen achieved the key secondary endpoint of pathological complete response, compared to 5.7% of patients who received neoadjuvant chemotherapy alone
In a subsequent interim analysis from RATIONALE 315, addition of tislelizumab to neoadjuvant platinum-based chemotherapy followed by adjuvant tislelizumab monotherapy demonstrated statistically significant improvement in event-free survival compared to neoadjuvant chemotherapy alone

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced that the Phase 3 RATIONALE 315 study met its dual primary endpoints of major pathological response (MPR) by Blinded Independent Pathology Review (BIPR) and event-free survival (EFS) by Blinded Independent Central Review (BICR), demonstrating statistically significant and clinically meaningful improvements in patients with resectable Stage II or IIIA NSCLC treated with tislelizumab in combination with chemotherapy before surgery and as a single agent after surgery versus neoadjuvant chemotherapy plus placebo followed by placebo after surgery. The tislelizumab plus chemotherapy regimen also showed a statistically significant improvement in pathological complete response (pCR), the key secondary endpoint, after neoadjuvant therapy versus chemotherapy. The MPR and pCR data will be featured as a late-breaking mini oral presentation on October 23 at 2:55 p.m. CEST at the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract #LBA58).

In the study, 56.2% of NSCLC patients treated with tislelizumab in combination with chemotherapy before surgery achieved MPR, compared to 15.0% of patients treated with chemotherapy alone (difference: 41.1%; 95% CI: 33.2-49.1, p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.