CStone and Blueprint’s GAVRETO approved for 1L RET+ NSCLC in China

CAR-T Digest - August 2020

Weekly Digest - 24-30 Jun 2023

27 Jun 2023: GAVRETO (pralsetinib) / 1L NSCLC / CStone: Approved by NMPA in China

The approval was based on the positive results from the Phase 1/2 ARROW trial
Phase 1/2 ARROW study to evaluate the safety, tolerability, and efficacy of GAVRETO in 1L RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC), and other advanced solid tumors with RET alterations (n = 589)
Results: n = 64; Data cut-off date: Mar 4, 2022; Advanced RET fusion-positive NSCLC; Dose: GAVRETO 400 mg QD
- Efficacy:
  - 1L NSCLC (n=30): ORR: 83.3% (1 CRs, 23 PRs); DCR: 86.7%
  - 2L NSCLC (n=33): ORR: 66.7% (1 CR, 21 PRs); DCR: 93.9%
  - mOS: Not reached
  - Long-term survival benefit was observed
- Safety:
  - Manageable safety profile with no new safety signals
This is the 3rd approval for GAVRETO in China and the 11th NDA approval that CStone has obtained in Greater China overall
- The other 2 approvals are for RET fusion-positive NSCLC after platinum-based chemotherapy (Mar 2021) and for RET-altered thyroid cancer (Mar 2022)
GAVRETO was discovered by CStone’s partner, Blueprint Medicines. CStone has an exclusive collaboration and license agreement with Blueprint Medicines for the development and commercialization of GAVRETO in Greater China, which encompasses mainland China, Hong Kong, Macau, and Taiwan
- Earlier in Feb 2023, Roche terminated its commercial collaboration with Blueprint citing falling sales forecasts for the GAVRETO
- Termination to be effective in February 2024 and the two companies will work to ensure continued patient access before Blueprint assumes full control