Shots:ImmunityBio has reported P-II (QUILT-3.055) trial data assessing Anktiva (nogapendekin alfa inbakicept-pmln) + checkpoint inhibitor immunotherapy (CPI) in CPI-resistant advanced NSCLCAmong 86 pts (51% 2L, 49% 3L+), mOS was 14.3mos. (23 alive at Dec 2025); 69/86 achieving ALC ≥1,200 had mOS of 15.8 vs 11.5mos. in non-achievers, while baseline ALC ≥1,200 & mean…
Shots:The UK’s MHRA has approved Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS. MAA is under the EMA’s review & covers all 30 EEA statesApproval was based on safety & efficacy data, incl. CR & DoR, from a single-arm trial in 77 pts treated with Anktiva + BCG, with some…
Shots:The EMA has accepted MAA of Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors, based on an ongoing QUILT 3.032 study. Application covers 27 EU countries, plus Iceland, Norway & Liechtenstein, with submission also made to the UK's MHRA
As of the data cut-off on Jul…
Shots: ImmunityBio’s Anktiva + Bacillus Calmette-Guérin (BCG) has received the US FDA’s approval to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and with/without papillary tumors. The US availability is anticipated by mid-May 2024 The approval & BTD was based on the study of 77 evaluable patients depicting a CR rate…

