Shots:
- The EC has granted conditional approval to Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors in all 30 EEA states, based on P-II/III (QUILT-3.032) study (n=100)
- Trial showed a 71% CR rate, with a median duration of CR of 26.6mos., plus DoR range was as long as 54mos. & ongoing. Among responders, CR rates were 66% at 12mos. & 42% at 24mos.
- Also, the cystectomy-free survival was 96%, 90%, & 84% at 12, 24, & 36mos., respectively, while disease-specific survival for all pts was 99% at both 24 & 36mos. Under the conditional approval, ImmunityBio will continue patient follow-up & submit long-term data to the EMA
Ref: Businesswire | Image: ImmunityBio | Press Release
Related News: ImmunityBio Reports Positive Clinical Results of ANKTIVA Plus Checkpoint Inhibitors in NSCLC
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