Genmab (GMAB) presented an update on its clinical pipeline at the Morgan Stanley 24th Annual Global Healthcare Conference, highlighting two breakthrough-therapy-designated assets and a pipeline expansion into the colorectal cancer market.
The company's shares have returned 24.9% over the past six months, trading at a P/E ratio of 26.6, while its market capitalization stands at $19.5 billion. Gross profit margin reached 93% in the first half of 2024, with revenue growing 25% year-over-year and operating profit rising 18%.
EPKINLY, Genmab's leading lymphoma franchise, posted 48% growth year-over-year and 28% quarter-over-quarter from Q1 to Q2. The drug has received regulatory approval in second-line follicular lymphoma in the United States, China and Europe, with Japan approval expected soon. Genmab's subcutaneous formulation — delivered as a two-second injection — has eliminated hospitalization requirements through a dedicated community study, shifting administration outside inpatient settings. The company said it is positioned one to one-and-a-half years ahead of major competitors in frontline diffuse large B-cell lymphoma data, a segment representing roughly half of EPKINLY's total addressable market.
Petosemtamab, a second-generation EGFR bispecific antibody targeting the LGR5 stem cell marker, reported an objective response rate of 63%, median progression-free survival of nine months and 12-month overall survival of 79% in its Phase II benchmark dataset. For comparison, pembrolizumab — the current standard of care — yields a response rate of approximately 19% and roughly one year of overall survival. The asset was evaluated across more than 300 clinical trial sites globally.
On Aug. 6, Genmab announced two Phase III trials expanding petosemtamab into colorectal cancer, a market described as approximately three times larger than the head and neck indication. The frontline study will enroll around 900 patients comparing petosemtamab plus FOLFOX or FOLFIRI with cetuximab against chemotherapy plus cetuximab alone. A second-line study will cover a broader population including patients previously treated with cetuximab or bevacizumab-based regimens. Detailed colorectal data is scheduled for presentation at the European Society for Medical Oncology (ESMO) conference in late October.
Genmab submitted its investigational new drug application for petosemtamab 24 hours after closing its Merus transaction on Dec. 12.
Rina-S, a folate receptor alpha-targeting antibody-drug conjugate, showed response rates of approximately 50% across the full range of FRα expression without requiring a companion diagnostic. Median duration of response exceeded 12 months, and the discontinuation rate due to adverse events was 3% to 4%. No eye or neurotoxicity was reported.
Data readouts are expected in the fourth quarter of 2024 for three lead programs: the LiGeR-HN1 frontline head and neck trial for petosemtamab, the frontline DLBCL study for EPKINLY, and the P-ROC ovarian cancer study for Rina-S. The LiGeR-HN2 second-line head and neck data for petosemtamab is expected in the first quarter of 2025, with multiple commercial launches potentially following in 2025.
