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Baekje Shenzhou: Phase 3 RATIONALE 315 trial of tirelizumab combined with chemotherapy for resectable NSCLC achieved its primary endpoint of MPR and EFS

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On October 22nd, the Baekje Shenzhou official announced that the Phase 3 clinical trial of Tirelizumab combined with chemotherapy for resectable NSCLC achieved its primary endpoints of MPR and EFS in the Phase 3 RATIONALE 315 trial. The Phase 3 clinical trial achieved its dual primary endpoints: primary pathological response (MPR) evaluated by blind independent pathological review (BIPR) and event free survival (EFS) evaluated by blind independent center review (BICR). Compared with placebo combined chemotherapy as a neoadjuvant treatment and receiving placebo treatment after surgery, resectable stage II or IIIA non-small cell lung cancer (NSCLC) patients who received tirolizumab combined chemotherapy before surgery and tirolizumab monotherapy after surgery showed statistically significant and clinically significant improvements. After neoadjuvant therapy, the combination of tirelizumab and chemotherapy also showed statistically significant improvement in pathological complete response (pCR) in the key secondary endpoint compared to chemotherapy alone.
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