Ash 2021 late-breakers enable neat comparisons

The Ash late-breaker abstracts, just unveiled, mean that a direct cross-trial comparison of three approved Car-T therapies in second-line lymphoma will be possible after all. Breyanzi’s Transform study and Yescarta’s Zuma-7 had already featured in the meeting’s main programme, and now Kymriah’s failed Belinda study has been confirmed as a late-breaker; no doubt much of the focus will be on trial differences and baseline imbalances. A separate neat comparison will be possible for Sanofi/Alnylam’s delayed haemophilia A and B RNAi project fitusiran, which secured a plenary spot for its Atlas-INH trial in patients with inhibitors. Today it became apparent that Atlas-A/B, in those without, will feature at a late-breaker. While both studies comfortably hit statistical significance in terms of annualised bleeding rate the spotlight will be on adverse events, which had prompted Sanofi to investigate a lower dose of fitusiran. Finally, Roche’s attempt to move Polivy into front-line lymphoma will be scrutinised with full data from the Polarix trial, earlier touted as the first in two decades to show improved PFS in front-line disease. The abstract suggests that the effect is modest, and moreover there is no benefit in overall survival.

Selected Ash 2021 presentations
Project Mech Company Trial Abstract Detail
Car-T therapy in 2nd-line B-cell lymphoma
Yescarta CD19 Car-T Gilead Zuma-7 2 (plenary) Median EFS 8.3mth vs 2.0mth for SoC (HR=0.398; p<0.0001)
Breyanzi CD19 Car-T Bristol Myers Squibb Transform 91 Median EFS 10.1mth vs 2.3mth for SoC (HR=0.349; P<0.0001)
Kymriah CD19 Car-T Novartis Belinda LBA-6 Median EFS 3.0mth vs 3.0mth for SoC (HR=1.07; p=0.69)
Haemophilia A & B
Fitusiran Antithrombin RNAi Sanofi/Alnylam Atlas-INH 4 (plenary) Pts with inhibitors: ABR 1.67 vs 18.07 for on-demand BPA (p<0.0001); 17.1% rate of serious TEAEs (NB old dosing regimen)
Atlas-A/B LBA-3 Pts without inhibitors: ABR 3.1 vs 31.0 for on-demand factors (p<0.0001); 6.3% rate of serious TEAEs (NB old dosing regimen)
1st-line B-cell lymphoma
Polivy CD79B ADC Roche Polarix LBA-1 mPFS HR=0.73 for Polivy-R-CHP vs R-CHOP (p<0.02); no difference in OS (HR=0.94, p=0.75)
Note: ABR=annualised bleeding rate; BPA=bypassing agents. Source: Ash.

Related Topics

Share This Article