Genmab A/S NASDAQ: GMAB expects a pivotal fourth quarter, with Phase III readouts planned for three late-stage oncology programs that the company views as potential first-in-class opportunities, according to Andrew Carlsen, the company’s vice president and head of investor relations.
Carlsen said Genmab had a “strong first half” operationally and financially and raised its guidance following second-quarter results. The top-line guidance increase was driven primarily by DARZALEX, with EPKINLY also contributing, he said.
Three Phase III Readouts Planned for Fourth Quarter
The company expects results during the fourth quarter from its frontline diffuse large B-cell lymphoma, or DLBCL, study of EPKINLY plus R-CHOP versus R-CHOP. The readout will be based on a prespecified interim analysis.
Genmab also expects a Phase III readout for Rina-S in second-line-plus platinum-resistant ovarian cancer during the quarter. Carlsen said the study was brought forward and could position Rina-S as a first-in-class next-generation folate receptor alpha antibody-drug conjugate in ovarian cancer.
The third expected Phase III result is from a study of petosemtamab plus KEYTRUDA versus KEYTRUDA in first-line metastatic head and neck cancer. Carlsen said the company sees the potential for each of the three programs to be first in class in their respective settings.
- EPKINLY could become the first bispecific to report Phase III data in frontline DLBCL.
- Rina-S could be first among next-generation folate receptor alpha ADCs in ovarian cancer.
- Petosemtamab could be first in frontline head and neck cancer.
Genmab has not provided a sequence or more specific timing for the individual fourth-quarter readouts. However, Carlsen said petosemtamab colorectal cancer data will be presented at the European Society for Medical Oncology congress, scheduled for Oct. 23 through Oct. 27.
Broader Development Plans for Rina-S and Petosemtamab
Rina-S entered Genmab’s portfolio through the 2024 acquisition of ProfoundBio. Carlsen said the program now has five active Phase III trials. Beyond the expected ovarian cancer readout, the company is advancing Phase III studies in second-line endometrial cancer and platinum-sensitive maintenance, while it announced trials in platinum-sensitive replacement and frontline endometrial cancer this year.
Genmab has also started Phase II signal-seeking studies of Rina-S in lung cancer and gastrointestinal solid tumors. Carlsen said the broad development effort reflects the company’s confidence in Rina-S across gynecologic oncology.
Petosemtamab was acquired through Genmab’s Merus acquisition, completed in December 2025. The company inherited Phase III studies in first-line and second-line metastatic head and neck cancer, and expanded enrollment by 200 patients in the first-line trial and 100 patients in the second-line trial.
The first-line study retains co-primary endpoints involving objective response rate and duration of response, as well as overall survival. The second-line trial was changed to a sole primary endpoint of overall survival. Genmab recently announced plans to initiate Phase III trials in first-line and second-line colorectal cancer, which Carlsen said were started earlier than initially anticipated because of encouraging underlying data.
For the planned fourth-quarter first-line head and neck update, Genmab expects to report objective response rate for petosemtamab plus pembrolizumab compared with pembrolizumab. Carlsen said the company’s prior Phase III disclosures have generally focused on the primary endpoint, with additional data typically presented later at medical conferences.
Confidence in Competitive Positioning
Carlsen said Genmab remains confident in petosemtamab’s profile versus competing programs, while acknowledging the limitations of cross-trial comparisons. He said the company believes the asset compares favorably on both efficacy and safety across the heterogeneous head and neck cancer population.
In previously presented Phase II data, petosemtamab showed a 50% objective response rate among a smaller group of HPV-positive patients, according to Carlsen. He said Genmab believes that signal is robust and that the Phase III trial was designed to reflect real-world metastatic head and neck cancer demographics.
For second-line head and neck cancer, Genmab expects a global randomized Phase III readout based on overall survival in the first quarter of next year. Carlsen said the company believes petosemtamab can compete in the setting despite Johnson & Johnson pursuing an accelerated-approval path for RYBREVANT based on response rate and duration of response.
In colorectal cancer, Genmab has followed patients longer and added more patients to the data set inherited from Merus. Carlsen said the decision to proceed into two Phase III colorectal trials indicates that the company continued to see encouraging signals.
Launch Expectations and Financial Considerations
Carlsen said Genmab anticipates launching all three major assets—EPKINLY in frontline DLBCL, Rina-S in platinum-resistant ovarian cancer, and petosemtamab in frontline head and neck cancer—during 2027 if the data and regulatory reviews support that timeline. The company has not specified whether priority reviews would be involved.
Genmab has projected petosemtamab could generate more than $1 billion in sales by 2029, though it has not provided comparable uptake guidance for EPKINLY or Rina-S. The company continues to describe petosemtamab’s peak-sales potential as “multi-billion dollar,” saying it is too early to provide a more specific estimate while colorectal and locally advanced head and neck studies remain in development.
Carlsen characterized Genmab’s strategy as building a standalone growth oncology franchise alongside its royalty portfolio. He said the company has expanded its commercial capabilities through the launches of TIVDAK and EPKINLY and is preparing to commercialize wholly owned medicines including Rina-S and petosemtamab.
He also noted that consensus estimates may need to account for additional research and development spending from newly added colorectal trials and anticipated locally advanced head and neck studies. Upon approvals and launches, Genmab expects to begin straight-line amortization of close to DKK 7 billion related to petosemtamab and more than DKK 1 billion related to Rina-S, Carlsen said.
About Genmab A/S (NASDAQ:GMAB)
Genmab A/S is a biotechnology company headquartered in Copenhagen, Denmark, focused on discovering, developing and commercializing differentiated antibody-based medicines. The company's research platforms include technologies designed to create human antibodies and bispecific antibodies that engage the immune system to target cancer and other serious diseases.
Genmab's products and partnered medicines include DARZALEX (daratumumab) for multiple myeloma, developed with Johnson & Johnson; Kesimpta (ofatumumab) for multiple sclerosis, developed with Novartis; and Tivdak (tisotumab vedotin) for cervical cancer, developed with Pfizer.
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