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: | Image: | Press Release
Related News:- BeiGene Reports the US FDA approval for Tevimbra + CT as a 1L Treatment of Advanced ESCC
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