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Emerging Agents in HNSCC

CE / CME

Emerging Targeted Therapies for HNSCC: A Focus on EGFR-Directed Bispecific Antibodies

Physician Assistants/Physician Associates: 0.25 AAPA Category 1 CME credit

Pharmacists: 0.25 contact hour (0.025 CEUs)

Physicians: maximum of 0.25 AMA PRA Category 1 Credit

Nurse Practitioners/Nurses: 0.25 Nursing contact hour

Released: July 28, 2026

Expiration: January 27, 2027

Activity

Progress
1 2 3
Course Completed

References

Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. The Lancet. 2019;394(10212):1915-1928.

Black CM, Hanna GJ, Wang L, et al. Real-world treatment patterns and outcomes among individuals receiving first-line pembrolizumab therapy for recurrent/metastatic head and neck squamous cell carcinoma. Frontiers in Oncology. 2023;13:1160144.

Chung CH, Li J, Steuer CE, et al. Phase II Multi-institutional Clinical Trial Result of Concurrent Cetuximab and Nivolumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma. Clinical Cancer Research. 2022;28(11):2329-2338.

Gulati S, Crist M, Kashif Riaz M, et al. Durvalumab plus Cetuximab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: An Open-label, Nonrandomized, Phase II Clinical Trial. Clinical Cancer Research. 2023;29(10):1906-1915.

Guo Y, Li DZ, Lin J, et al. Safety and efficacy of toripalimab combined with cetuximab in PD-L1 positive untreated recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): A phase Ib/II study. Presented at: 2024 European Society for Medical Oncology Annual Congress. September 13-17, 2024. Abstract 872P.

Burtness B, Harrington KJ, Ji D, et al. Amivantamab in HPV-unrelated recurrent/metastatic head and neck squamous cell cancer after disease progression on immune checkpoint inhibitor and chemotherapy: Pivotal results from the phase 1b/2 OrigAMI-4 study. Presented at: 2026 American Society of Clinical Oncology Annual Conference. May 29-June 2, 2026. Abstract 6008.

Swiecicki PL, Keam B, Li S-H, et al. Amivantamab plus paclitaxel in recurrent/metastatic (R/M) head & neck squamous cell cancer (HNSCC) after disease progression on checkpoint inhibition: Identification of the recommended combination dose from the phase Ib/II OrigAMI-4 study. ESMO 2025. Abstract 1352P.

Haddad R, Ferrarotto R, Guo Y. OrigAMI-5: A randomized, phase 3 study of amivantamab plus pembrolizumab and carboplatin vs standard of care pembrolizumab plus platinum and 5-fluorouracil as first-line treatment in recurrent/metastatic head and neck cancer. ASCO 2026. Abstract TPS6127. NCT07276399

Hanna G, Zandberg D, Wong D, et al. Ficerafusp Alfa (BCA101) With Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Two-Year Results of an Expansion Cohort of a Phase I/Ib Trial. JCO. 2026;44:1697

Wong D, Chung C, Hanna G, et al. Depth and durability of response with TGF-β trapping in recurrent or metastatic (R/M) HPV-negative head and neck squamous cell carcinoma (HNSCC): Long-term results from two expansion cohorts of a phase 1/1b study of ficerafusp alfa plus pembrolizumab. ASCO 2026. Abstract 6040.

Ferrarotto R, Kaczmar J, Spigel D, et al. A multicenter, randomized, double-blind, phase 2/3 study of ficerafusp alfa (BCA101) or placebo in combination with pembrolizumab for first-line treatment of HPV-negative, PD-L1–positive, recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): FORTIFI-HN01. ASCO 2026. Abstract TPS6129. NCT06788990.

T McDonald, et al. Identification and cloning of an orphan G protein-coupled receptor of the glycoprotein hormone receptor subfamily. Biochem Biophys Res Commun. 1998 Jun 18;247(2):266-70. doi: 10.1006/bbrc.1998.8774

van Herpen C, Daste A, Arrazubi V, et al. Petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of PD-L1+ recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 trial. ASCO 2026. Abstract 6024. NCT03526835.

Cohen EE, Fayette J, Daste A, et al. Clinical activity of MCLA-158 (petosemtamab), an IgG1 bispecific antibody targeting EGFR and LGR5, in advanced head and neck squamous cell cancer (HNSCC). AACR 2023. Abstract CT012. NCT03526835.

Fayette J, Adkins DR, Psyrri A, et al. Petosemtamab plus pembrolizumab vs. pembrolizumab alone for first-line (1L) treatment of recurrent/metastatic (r/m) PD-L1–positive head and neck squamous cell carcinoma (HNSCC): A randomized, open-label, phase III trial. ESMO 2024. Abstract 944TiP. NCT06525220.

Haddad R, Gillison M, Harrington KJ, et al. Petosemtamab compared with investigator’s choice monotherapy in previously treated patients (pts) with recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): A randomized, open-label, phase III trial. Abstract 943 TiP. NCT06496178.