Global Pharmaceuticals "ABBV/GMAB - reiterating high conviction on Epkinly..."

Research evidence excerpt

Global Pharmaceuticals "ABBV/GMAB - reiterating high conviction on Epkinly..."

years or so. As the P3 Epkinly 1L DLBCL trial is a large, well designed study run by ABBV

and GMAB, we believe it is likely that the control arm in this trial is consistent versus R-

CHOP arms in prior trials, and we are cautiously optimistic that the slow event accrual

rates might be another positive on top of the fact that the interim has not passed.

Having said that, all clinical trials carry execution risks, and generally it is hard to call the

potential implication when events happen slower than expected in oncology trials.

See Figure 4R-CHOPPFScurvesfor1LDLBCLinIPI3-5patientsfromMonjuviP3frontMINDstudy,Sehnet.al.realworldanalysis,andRupertet.al.metaanalysis,sugestingR-CHOPperformanceisrelativelyconsistentacrostrialsandrealworld. for R-CHOP PFS comparison in IPI 3-5 patients from Monjuvi P3 frontMIND

study, Sehn et. al. real world analysis, and Ruppert et. al. meta analysis, and Figure 5R-CHOPPFScurvesfor1LDLBCLinP3GOYAtrial(alIPI),P3REMoDL-Btrial(alIPI)andP3POLARIXtrial(IPI2-5) for

R-CHOP PFS comparison for patients with all IPI status from GOYA P3 and REMoDL-B

trial (even the R-CHOP arm from the POLARIX trial with IPI 2-5 is fairly comparable).

Up/downside on GMAB, and what if the trial does not stop for interim and

progress to full readout?

We believe GMAB could be up ~20% in our blue sky scenario if Epkinly 1L DLBCL trial is

positive with HR < 0.65, the efficacy level where KOLs believe is enough to drive usage

versus Polivy-R-CHP regimen, which is approved in 1L DLBCL (Figure 1GenmabEpkinlyP31LDLBCLscenarioup/downsideanalysis). However, as the

interim has not passed, and though GMAB has guided for 2026 for this readout, we