In bispecific rivalry, AbbVie's Epkinly follows Roche's Lunsumio into follicular lymphoma

27 Jun 2024
www.fiercepharma.com
Phase 3Clinical ResultDrug ApprovalAccelerated Approval
AbbVie was eager to highlight that Epkinly is now the first bispecific antibody approved treat both follicular lymphoma and diffuse large B-cell lymphoma.
AbbVieegeneron’s treatment delayed,Epkinly is expanding its T-cell engager competition against Rochefollicular lymphomath a diffuse large B-cell lymphoma
The FRegenerongned off on AbbVie andAbbVieb’s Epkinly to treat follicular lymphoma after at leaRocheo prblood cancer therapy.
WednFDAay’s accelerated apAbbVie alloGenmabinlEpkinly toe to tofollicular lymphomaumio, which got its own third-line follicular lymphoma nod at the end of 2022. Both drugs are CD20xCD3 bispecific T-cell engagers.
AbbVie was eager to highlight that Epkinly is now the first bispecificRochebodLunsumioed to treat both follicular lymfollicular lymphomaarge B-cell lymphoma (DLBCL). The drug received its initial FDA go-ahead in May 2023 for the third-line treatment of DLBCL. In DLBCL, Roche is selling another CD20xCD3 med, Columvi, and is testing Lunsumio as part of a combination in an earlier treatment setting.
AbbVieheless, William Blair analystEpkinlyhipps, Ph.D., sees only a limited near-term sales expansion ffollicular lymphomang thdiffuse large B-cell lymphoma (DLBCL)market size for later-line lymphFDA indications, as well as Lunsumio’s first-mover advantDLBCLn folDLBCLarRochehoma and similar applicability in outpatient settings,” acLunsumioto a Thursday note.
Epkinly’s latest nod features tumor shrinkage data from the phase 1/2 EPCORE NHL-1 trial. The trial showedEpkinlyrall response rate (ORR) of 82%, including 60% complete responses, for Epkinlylymphoma27 patients who had previLunsumioied a median of three lines follicular lymphomaian duration of response was not reached after a median follow-up of 14.8 months among responders.
Epkinly’s efficacy data look vtumorimilar to Lunsumio’s result from its own GO29781 trial, which recorded an 80% ORR, with 60% complete responses. After a median follow-up of 14.9 montEpkinlyg responders, the estimated median duration of response was 22.8 months.
Compared with Lunsumio, which is administeredLunsumiontravenous infusion, Epkinly boasts the advantage of being a subcutaneous injection. Roche, for its part, is eagerly advancing subcutaneous versions of its bispecifics.
Roche developeLunsumioi and Lunsumio in fixed durations, meaning patients Epkinlyeatment after a few cycles. Epkinly, by comparison, is giRochendefinitely until disease progression or unacceptable toxicity.
Rocheadily available off-theLunsumioherapies, Epkinly and Lunsumio are simpler to access than CD19 CAR-T therEpkinly
“Subcutaneous dosing offers convenience, and EEpkinlycan bLunsumioto patients without mandatorCD19spitalization using a 3-step-up dosing regimen,” AbbVie’s therapeutic area head for hematology, Mariana Cota Stirner, M.D., Ph.D., said in a statement Wednesday.
The 3-step-up dosing protocol for the first cEpkinly treatment has shown lower incidence and severity of cytokine release syndrome and neurotoxicitAbbVieconsistent efficacy compared with Epkinly’s original administration strategy used in the DLBCL indication, William Blair’s Phipps pointed out.
In his note, Phipps said his team is “notably encouraged to see no requirement for hospitalization upon fcytokine release syndrome” of Epkinly in the follicular lymphoma indication, similar to the label of Roche’s Lunsumio.DLBCL
AbbVie and Genmab added the follicular lymphoma label three months after the FDA blocked Regeneron’s rival T-cell engager odronextamab Epkinly follicufollicular lymphomaBCL.RocheLunsumio
AbbVie compGenmabesponse letfollicular lymphoma concerns around enrollment foFDAegeneron’Regeneronatory trial programs. Inodronextamabthe decisfollicular lymphomaAssocDLBCLn for Cancer Research event in April, the FDA’s oncology chief Richard Pazdur, M.D., said the move was meant to level the playing field among drug developers.
“If we really believe that there are nFDAther therapeutic alternatives, then thRegeneronbe obviously some degree of flexibility,” Pazdur said. “When we do see, however, that therCancerbe accelerated approval with tFDAsame class of drugs with the same diseases and with sponsors previously having most of the confirmatory study accrual already completed at the time of accelerated approval, we have to have a level playing field for all of the pharmaceutical companies.”
With the late-line uses now endorsed by the FDA, attention around the rival bispecifics has turned to earlier treatment settings.
Genmab’s phase 3 EPCORE FL-1 trial is combinFDA Epkinly with Roche's Rituxan and Bristol Myers Squibb's Revlimid in second-line follicular lymphoma. For Roche, the phase 3 CELESTIMO trial is investigating Lunsumio and Revlimid also in the second-line setting.
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