The P-III trial evaluating TTFields therapy + ICI or docetaxel vs ICI or docetaxel alone. The trial met its 1EPs & showed a 3mos. improvement in m-OS (13.2 vs 9.9mos.) in patients with TTFields therapy + standard therapies, profound OS benefit in the ICI subgroup
m-OS (18.5 vs 10.8mos.) in patients with TTFields therapy and ICI; 11.1mos. in TTFields therapy & docetaxel vs 8.7mos. in docetaxel alone, was well-tolerated with no added systemic toxicities and few grade 3 device-related AEs
Baseline characteristics were well balanced b/w cohorts, 1yr. & 3yr. survival rates in TTFields therapy + standard therapies (53% vs 42%) & (18% vs 7%); m-PFS (4.8 vs 4.1mos.). Based on the P-III trial results, the PMA submission to the US FDA is expected in H2’23
Ref: Globenewswire | Image: Zai Lab
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