Neil Stone, Honorary Associate Professor at University College London, shared on X:
“A real cancer breakthrough this week: petosemtamab plus pembrolizumab halved the risk of death in a phase 3 head and neck cancer trial.
Humans, not mice.
No ivermectin in sight.”
About Petosemtamab and Phase 3 LiGeR-HN1 trial
Petosemtamab (GEN1158) is an investigational IgG1 bispecific antibody targeting EGFR and LGR5 (expressed on cancer stem-like cells). There are three complementary mechanisms:
- blocking EGFR signaling,
- inducing EGFR degradation through LGR5 internalization,
- and triggering antibody-dependent cell-mediated cytotoxicity (ADCC).
Petosemtamab holds U.S. FDA Breakthrough Therapy Designation for first-line PD-L1+ recurrent/metastatic HNSCC (in combination with pembrolizumab) and for previously treated recurrent/metastatic HNSCC.
Genmab announced positive results from the Phase 3 LiGeR-HN1 study (NCT06525220) evaluating petosemtamab combined with pembrolizumab versus pembrolizumab alone as first-line treatment for patients with PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
The trial met both co-primary endpoints at the first interim analysis, demonstrating a statistically significant and clinically meaningful improvement in both Overall Survival (OS) and Objective Response Rate (ORR), regardless of HPV status. The petosemtamab combination reduced the risk of death by 50% compared to pembrolizumab monotherapy.
Genmab plans to engage global regulatory authorities based on these results and will present full data at an upcoming medical meeting.
Beyond LiGeR-HN1, petosemtamab is being evaluated in Phase 3 trials for second/third-line HNSCC (LiGeR-HN2) and metastatic colorectal cancer (LiGeR-CRC1 and LiGeR-CRC2).
You can also read: Cesar Perez: New LiGeR-HN1 Results Mark a Milestone in Head and Neck Cancer Treatment