Shots:
- The US FDA has approved Ibtrozi (taletrectinib) for treating locally advanced or metastatic ROS1+ NSCLC
- Approval was based on the P-II [TRUST-I (China) & TRUST-II (global)] studies assessing Ibtrozi monotx. in 173 & 164 pts with ROS1+ NSCLC, respectively
- TRUST-I showed a cORR of 90% in TKI-naïve pts, with longest DoR of 46.9mos. & ongoing (mFU: 40mos.) while TRUST-II showed 85% cORR with DoR of 30.4mos. & ongoing, as of Oct 2024 (mFU: 19mos.); mDoR was not yet reached for either trial. Among TKI-pretreated pts, TRUST-I showed a cORR of 52% with a mDoR of 13.2mos. (mFU: 33mos.), & TRUST-II showed a cORR of 62% with a mDoR of 19.4mos. as of Oct 2024 (mFU: 19mos.); due to TRUST’s single-arm design, mPFS was not incl. in label
Ref: Nuvationbio | Image: Nuvationbio| Press Release
Related News:- BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors
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