Also known as: HNSCC
Head and neck squamous cell carcinoma (HNSCC) is a group of cancers arising from squamous cells in the mucosal lining of the mouth, nose, and throat. It is strongly associated with tobacco/alcohol exposure and, in some subtypes, HPV infection. Disease biology and treatment response vary by molecular and etiologic subtype.
The FDA approved Keytruda and Keytruda Qlex with paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian-related cancers. The Phase III KEYNOTE-B96 trial showed improved progression-free and overall survival versus placebo.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
A retrospective study of 692 matched HNSCC trials found that sponsor-driven decisions and poor recruitment were the leading causes of early termination. The analysis also identified enrollment, funding source, trial phase, and inclusion of procedures or surgery as factors associated with failure.
The FDA has approved Agilent's PD-L1 IHC 22C3 pharmDx as a companion diagnostic for identifying esophageal cancer patients eligible for Merck's KEYTRUDA immunotherapy. This marks the eighth FDA-approved indication for this diagnostic test with KEYTRUDA. The test helps identify patients whose tumors express PD-L1 for potential treatment with the anti-PD-1 therapy.
Diamyd Medical anticipates March 2026 interim results from its Phase 3 diabetes trial that could support a BLA pathway. Capricor Therapeutics awaits an August 2026 FDA decision on its Duchenne muscular dystrophy treatment BLA. Bicara Therapeutics prepares for Phase 3 study initiation of its oncology candidate toward future BLA submission.
Percheron Therapeutics outlines its phase II development strategy for HMBD-002, a VISTA-targeting immuno-oncology drug. The company reports favorable phase I safety data and plans an adaptive, multi-arm phase II trial starting in 2026. HMBD-002 is designed as a next-generation checkpoint inhibitor with potential to overcome limitations of existing therapies.
Meta-analysis of 23 trials finds neoadjuvant chemoimmunotherapy achieved 66% major pathologic response in head and neck cancer patients compared to 18% for dual-agent and 6% for single-agent immunotherapy, though survival impact remains unclear.
The U.S. FDA granted Breakthrough Therapy Designation for subcutaneous Rybrevant Faspro as monotherapy for adults with advanced head and neck squamous cell carcinoma, based on Phase 1b/2 study data showing rapid and durable responses.
The FDA has approved a monthly dosing schedule for Rybrevant Faspro in EGFR-mutated NSCLC and granted breakthrough therapy designation for the drug as monotherapy in HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma after prior therapy.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07602842 |
A Study of IDP-001 in Advanced or Metastatic Solid Tumors |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07601737 |
Nimotuzumab Combined With PD-1 Inhibitors and Chemotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma |
RECRUITING | PHASE2 |
| NCT07589205 |
Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metastatic Solid Tumors |
RECRUITING | PHASE1 |
| NCT07589049 |
Becotatug Vedotin Combined With Pucotenlimab as Neoadjuvant Therapy for Resectable Recurrent Head and Neck Squamous Cell Carcinoma After Progression on Immunotherapy: A Prospective Phase II Study |
NOT_YET_RECRUITING | PHASE2 |
| NCT07586124 |
Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07572864 |
Neoadjuvant ICI and Mitochondrial Vaccine for Resectable HNSCC |
RECRUITING | PHASE2 |
| NCT07567235 |
Clinical Study of CFH Protein Via Ice Microneedles for Radiation-Induced Skin Fibrosis |
RECRUITING | PHASE1 |
| NCT07554768 |
Neoadjuvant Radio-immunotherapy Versus Immunotherapy Alone for Locally Advanced HNSCC |
NOT_YET_RECRUITING | PHASE2 |
| NCT07552558 |
Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC) |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07535567 |
Postoperative Radiotherapy With Nimotuzumab ± Benmelstobart in Intermediate-Risk Head and Neck Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
