BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
Shots:
- The MAA was based on the evaluation of NSCLC patients (n=1,499) in 3 P-III studies incl. (RATIONALE 307) for Tevimbra + carboplatin + paclitaxel/nab-paclitaxel vs CT (1L treatment for sq. NSCLC), (RATIONALE 304) for Tevimbra + pemetrexed + platinum-containing CT vs CT (1L treatment for non-sq. NSCLC) & (RATIONALE 303) for Tevimbra vs CT (locally advanced/metastatic NSCLC)
- At 8.6mos. follow-up, (RATIONALE 307) showed a PFS of 7.6 & 7.6 vs 5.5mos. & ORR of 72.5 & 74.8 vs 49.6%, at 9.8mos. follow-up (RATIONALE 304) showed a PFS of 9.7 vs 7.6mos & (RATIONALE 303) showed an OS of 17.2 vs 11.9mos.
- Tevimbra, an IgG4 anti-PD-1 mAb, received the EC’s approval for ESCC in 2023 & is under review by the US FDA for ESCC
Ref: BeiGene | Image: BeiGene
Related News:- BeiGene to Present P-III Trial (RATIONALE 315) Results of Tislelizumab for Resectable Non-Small Cell Lung Cancer at ESMO Congress 2023
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
