Xian Deng

Xian Deng asked for clarification on the definition of a readout for the Rina-S pivotal Phase II study, given it's not a formal Phase III, and a quick confirmation on whether the EPKINLY frontline DLBCL trial passed its interim analysis.

Answer

CEO Jan van de Winkel, Chief Development Officer Judith Klimovsky, and CMO Tahamtan Ahmadi addressed the questions. Klimovsky explained that the Rina-S pivotal Phase II study is designed for accelerated approval based on ORR and duration of response, which are validated surrogate endpoints for clinical benefit, supported by ongoing Phase III studies with PFS as a primary endpoint. Ahmadi stated that Genmab expects the EPKINLY frontline DLBCL study readout in 2026, declining to comment on interim analysis specifics.

Xian Deng asked about the definition and determinants of the Rina-S pivotal Phase 2 readout, specifically regarding the use of ORR and duration of response (DoR) as endpoints given it's not a formal Phase 3 trial. Additionally, she sought confirmation on whether the Epkinly frontline DLBCL trial had passed its interim analysis.

Answer

Chief Development Officer Judith Klimovsky explained that the Rina-S pivotal Phase 2 study was designed to support accelerated approval based on ORR and DoR, which are validated surrogate endpoints for clinical benefit. She noted that accelerated approval is contingent on having Phase 3 studies with clinical endpoints, such as the ongoing O-two study with PFS as its primary endpoint. CMO Tahamtan Ahmadi stated that the Epkinly frontline DLBCL readout is expected in 2026, declining to comment on the interim analysis status.

Xian Deng of UBS asked for a sales breakdown of EPKINLY between follicular lymphoma (FL) and DLBCL, physician feedback on its differentiation, and the expected duration of use in second-line FL.

Answer

CCO Brad Bailey declined to provide a specific sales split but noted robust uptake post-FL launch, with physicians valuing its dual indication, subcutaneous administration, and no hospitalization requirement. CMO Tahamtan Ahmadi clarified the study regimen for second-line FL is a fixed 12-month duration and the regulatory submission is based on a strong interim overall response rate.

Xian Deng of UBS Group AG posed several questions about acasunlimab (GEN1046), asking about the long-term safety profile regarding liver toxicity, the data cutoff dates for the upcoming ASCO abstract versus the final presentation, and whether the Phase III trial will target all PD-L1 positive patients or a more specific high-expression subgroup.

Answer

Chief Medical Officer Tahamtan Ahmadi confirmed that based on substantial experience, the liver toxicity of acasunlimab appears manageable with no evidence of accumulation over time. He stated that the ASCO presentation will feature more updated data than the abstract. Dr. Ahmadi also clarified that the Phase III trial is intended to enroll PD-L1 positive patients, as PD-L1 expression is required for the drug's mechanism of action, which involves activating 4-1BB on T cells.

Xian Deng asked about VYVGART's Phase 2 myositis data, specifically the 23% injection site erythema, inquiring about its seriousness, mitigation strategies, and physician feedback, especially concerning patients with interstitial lung disease. She also asked for comments on the competitive landscape, given Roivant's recent positive Phase 3 data for brepocitinib in dermatomyositis.

Answer

Tim Van Hauwermeiren, Chief Executive Officer, welcomed Roivant's data, noting that myositis is a large market needing multiple therapies, and brepocitinib will help build the market without being a sole solution. Regarding erythema, he described it as mild, transient, typically occurring with the first administration, and not unusual or a barrier to commercialization.

Xian Deng from UBS asked about the 23% injection site erythema observed in VYVGART's Phase II myositis data, its seriousness, and mitigation strategies. She also inquired about the competitive landscape, specifically Roivant's positive Phase III data for brepocitinib in dermatomyositis, and its implications for argenx's broader myositis trial.

Answer

Tim Van Hauwermeiren, Chief Executive Officer, characterized the injection site erythema as mild, transient, and not a commercialization barrier, noting it's a known phenomenon from gMG and CIDP. Regarding competition, he welcomed Roivant's data in dermatomyositis, stating that the large market and unmet needs will accommodate multiple therapies, and that brepocitinib will help shape and build the market without being a sole solution.

Xian Deng asked for color on the net price difference between the EU and the U.S. and how to assess the commercial opportunity for the pre-filled syringe (PFS) in Europe, considering infrastructure and pricing dynamics.

Answer

Chief Operating Officer Karen Massey reiterated that argenx has taken a disciplined approach to ex-U.S. pricing to ensure financial sustainability and is well-positioned on net price. She agreed that the PFS represents a big opportunity ex-U.S., noting the fast conversion from IV to the Hytrulo butterfly presentation in Europe. She expects the PFS to accelerate this trend and drive continued growth outside the U.S., with the first patient already dosed in Germany.

Xian Deng asked what gives Argenx confidence in its Sjogren's disease Phase III trial, given the indication has been historically challenging for biologics, and how it will manage patients on prior medications.

Answer

CEO Tim Van Hauwermeiren explained that confidence comes from the Phase II signal-finding study, which demonstrated a convincing biological signal. He noted that clearing immune complexes led to consistent improvements across multiple clinical scales. The study also provided crucial learnings on how to mitigate the impact of background medications for the Phase III design.

Xian Deng from Berenberg inquired if the U.S. technology transfer for the CAR-T platform is the primary gating factor for accelerating trial enrollment and advancing to pivotal stages, or if progress is more dependent on strategic capital allocation.

Answer

Jeevan Shetty, Head of Development Oncology, confirmed the tech transfer is a crucial step linked to the IND filings for NHL and CLL, which will accelerate U.S. recruitment. CFO & COO Thad Huston added that the Landmark Bio site is ready, with more sites being added in the U.S. and Europe to support all clinical studies, indicating a clear focus on platform expansion.