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 granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
Kura Oncology's ziftomenib shows 96% complete response in frontline AML and $5.8M in early commercial sales; updated FIT-001 trial data for kidney cancer to be presented at 2026 summit; analysts see significant upside with an average target of $32.45.
A JAMA Otolaryngology study found most head and neck trial failures stem from strategic sponsor decisions and poor recruitment, while broader analysis shows site selection and feasibility missteps often cause trials to struggle before enrollment.
Three trials show ultra-low-dose checkpoint inhibitors retain efficacy with reduced toxicity and dramatically lower costs. DELII and Patil et al. trials tested low-dose nivolumab in solid tumors and HNSCC; NIVIPIT tested intratumoral low-dose ipilimumab in melanoma.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07766226 |
Online Sharing for Head & Neck Cancer Support |
NOT_YET_RECRUITING | NA |
| NCT07758621 |
SYS6010 vs Investigator's Choice of Monotherapy in Patients With Recurrent or Metastatic HNSCC |
NOT_YET_RECRUITING | PHASE3 |
| NCT07744126 |
A Study to Assess Adverse Events, Change in Disease Activity and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan With IV Pembrolizumab for First-Line Treatment of Adult Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07743723 |
A Study of IOV-5001 in Adults With Advanced Solid Tumors |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07690618 |
Thermotherapy for Head and Neck Cancer Patients |
NOT_YET_RECRUITING | PHASE1 |
| NCT07683507 |
Becotatug Vedotin Plus PD-1 Inhibitor for Head and Neck Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07682285 |
Taiwanese Green Propolis for Lipid Profiles, Fatigue, and Quality of Life in Oral Cavity Cancer Survivors |
COMPLETED | NA |
| NCT07677475 |
MRG003 Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07667400 |
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07659678 |
CCR2 PET Imaging Head and Neck Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
