REG-Genmab Announces Updated Phase 2 Data Demonstrating More Than Two-Year Median Overall Survival with Petosemtamab Plus Pembrolizumab in First-Line Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Key Highlights
- ➤Median overall survival reached 28.2 months in first-line combination arm
- ➤Overall response rate reached 63%, including a 19% complete response rate
- ➤Median progression-free survival was 9.0 months; 12-month PFS rate was 40%
- ➤Phase 3 first-line HNSCC program ongoing, with topline data anticipated later this year
Expert Statements
Amaury Daste, M.D., Medical Oncologist, Hospital Center University de Bordeaux, France, and study investigator
“For patients with recurrent or metastatic head and neck squamous cell carcinoma, there is an ongoing need for new treatment approaches that may help expand options beyond currently available regimens”
Amaury Daste, M.D., Medical Oncologist, Hospital Center University de Bordeaux, France, and study investigator
“The median overall survival of 28 months observed with petosemtamab plus pembrolizumab in this trial, along with a manageable safety profile, are impressive.”
Amaury Daste, M.D., Medical Oncologist, Hospital Center University de Bordeaux, France, and study investigator
“It is also particularly noteworthy that responses were observed across patient subgroups and continued to be maintained at the time of analysis, an important consideration for patients facing a disease where durable disease control remains a critical treatment goal.”
Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab
“These findings strengthen our confidence in petosemtamab’s potential to make a meaningful difference in first-line head and neck cancer”
Tahamtan Ahmadi, M.D., Ph.D., Executive Vice President and Chief Medical Officer, Head of Experimental Medicines, Genmab
“Seeing responses across both HPV-positive and HPV-negative disease reinforces our ambition to reach a broad patient population and our commitment to advancing the petosemtamab clinical development program.”
COPENHAGEN, Denmark; October 26, 2026 * Median overall survival (OS) outcomes and encouraging anti-tumor activity observed with petosemtamab plus pembrolizumab in first-line (1L) recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma (r/m HNSCC), with responses observed across HPV-positive and HPV-negative disease * Phase 3 program in 1L HNSCC is ongoing, with topline data anticipated later this year Genmab A/S (Nasdaq: GMAB) today announced updated results from a Phase 2 trial evaluating petosemtamab, an investigational IgG1-bispecific antibody targeting the epidermal growth factor receptor (EGFR) and leucine-rich repeat containing G-protein-coupled receptor 5 (LGR5), in combination with pembrolizumab for first-line (1L) treatment of recurrent/metastatic PD-L1+ head and neck squamous cell carcinoma (r/m HNSCC). In the 1L combination arm, treatment with petosemtamab plus pembrolizumab achieved a median overall survival (OS) of 28.2 months, associated with an overall response rate (ORR) of 63% and median progression free survival (mPFS) of 9.0 months in efficacy-evaluable patients (n=43), including a complete response (CR) rate of 19%. The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2026, held in Madrid, Spain.
Get started
Create a free account to read the full story.