# EGFR-directed bispecific + PD-1 blockade

Source: https://onco.cc/pairings/egfr-bispecific-plus-pd1-hnscc/  
OnCo record `egfr-bispecific-plus-pd1-hnscc` (Pairing). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Pairing a new EGFR antibody with immunotherapy tripled the response rate seen with immunotherapy alone in early trials.

## Summary

This combination pairs an EGFR-directed bispecific antibody, petosemtamab or ficerafusp alfa, with the PD-1 inhibitor pembrolizumab in head and neck squamous cell carcinoma. EGFR blockade with ADCC-competent antibodies induces immunogenic cell death and, in the case of ficerafusp, also removes TGF-beta-mediated immune exclusion; PD-1 blockade then sustains the resulting T-cell response. In phase 2 single-arm studies, petosemtamab with pembrolizumab produced a response rate far above that expected with immunotherapy alone, and ficerafusp alfa with pembrolizumab produced durable responses in HPV-negative disease. Both pairings are now in registrational phase 3 trials, LiGeR-HN1 and FORTIFI-HN01, so the evidence remains uncontrolled for the moment.

## Fields

- Kind: Pairing
- Last checked: 2026-09-07
- Pairs: Petosemtamab + Pembrolizumab
- Type: combination
- Rationale: EGFR blockade with ADCC-competent antibodies induces immunogenic cell death and, for ficerafusp, removes TGF-β-mediated exclusion; PD-1 blockade sustains the resulting T-cell response.
- Evidence: Phase 2 single-arm data; phase 3 pending (LiGeR-HN1, FORTIFI-HN01).

## Sources

- ClinicalTrials.gov NCT06525220: LiGeR-HN1: https://clinicaltrials.gov/study/NCT06525220
- ClinicalTrials.gov NCT06788990: FORTIFI-HN01: https://clinicaltrials.gov/study/NCT06788990

## Connected records

- cancers: [Head and neck squamous cell carcinoma](https://onco.cc/cancers/head-and-neck/)
- targets: [EGFR](https://onco.cc/targets/egfr/), [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Ficerafusp alfa](https://onco.cc/drugs/ficerafusp-alfa/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/), [Petosemtamab](https://onco.cc/drugs/petosemtamab/)
- trials: [FORTIFI-HN01](https://onco.cc/trials/fortifi-hn01/), [LiGeR-HN1](https://onco.cc/trials/liger-hn1/)

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