Genmab (GMAB) Wells Fargo 21st Annual Healthcare Conference summary

Pipeline and upcoming data disclosures

• Three major phase III assets—epcoritamab, Rina-S, and petosemtamab—are advancing, with three phase III readouts expected in the next quarter.

• Epcoritamab's first-line DLBCL study will have an interim analysis in Q4, focusing on PFS as the primary endpoint, with OS data expected to be immature.

• Petosemtamab's first-line head and neck cancer phase III interim readout is expected next quarter, with robust enrollment to accelerate OS data collection.

• Rina-S phase III and phase II arm C data in PROC will be disclosed in Q4, with expectations for best-in-class efficacy and safety.

• Indication expansion is planned for Rina-S in ovarian and endometrial cancers, aiming for broad positioning as the ADC of choice.

Epcoritamab clinical and commercial insights

• DLBCL-4 data showed reduced risk of progression by 60% and death by 56% versus R-GemOx, highlighting versatility in combination regimens.

• The largest commercial opportunity is in first-line DLBCL, with the upcoming DLBCL-02 readout seen as pivotal.

• Removal of mandatory hospitalization and label expansion have accelerated community uptake, with cross-pollination between indications.

• Shorter treatment duration in phase III is not expected to impact efficacy, as responses and MRD negativity occur early.

• PFS is a validated regulatory endpoint for first-line DLBCL, with OS data expected to mature over time.

Petosemtamab development and market positioning

• Phase III interim analysis will focus on ORR and duration of response, with phase II data showing 63% ORR and 79% OS at 12 months in first-line head and neck cancer.

• No cap on HPV-positive patients; efficacy in this subgroup is strong, supporting inclusion without enrichment.

• Second-line study now targets full approval with OS as the primary endpoint, as first-line remains the larger commercial opportunity.

• Competitive landscape includes amivantamab, but petosemtamab is positioned for time and efficacy advantage, especially with a chemo-free regimen.

• In CRC, two phase III trials target KRAS/BRAF wild-type patients, with strong preclinical and clinical rationale for LGR5 targeting.