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DelveInsight estimates that in 2024, there were approximately 168,000 incident cases of head and neck cancer across the seven major markets [the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Most of the head and neck tumors are histologically classified as squamous cell carcinomas (nearly 90%). The rising incidence of head and neck squamous cell carcinoma (HNSCC) is strongly associated with human papillomavirus (HPV) infection, with more than 90% of oropharyngeal cancer cases attributed to HPV in the US. Among these, the HPV16 subtype is responsible for around 90% of the cases. There is an opportunity to enhance current HNSCC treatments by developing immunotherapeutic approaches specifically designed to target HPV biology. The current treatment landscape of head and neck cancer is primarily dominated by targeted therapies and immunotherapies, such as ERBITUX (cetuximab), OPDIVO (nivolumab), and KEYTRUDA (pembrolizumab), which continue to serve as the backbone of clinical management.
Leading companies, including Merck Sharp & Dohme, Bristol Myers Squibb, Sichuan Kelun-Biotech Biopharmaceutical, Shanghai Miracogen, Janssen, Merus, Bicara Therapeutics, and Pfizer—will present their latest clinical developments in head and neck cancers.
Major highlights among several abstracts include data from Bristol Myers Squibb’s Phase III NIVOPOSTOP trial. This study aims to determine whether adding adjuvant OPDIVO to standard chemoradiation can help reduce relapse rates in patients with high-risk resected head and neck squamous cell carcinoma. Apart from this, experts are likely to closely monitor data from Merus’ bispecific antibody [Petosemtamab (MCLA-158)] and Bicara’ bispecific fusion protein (Ficerafusp alfa).
Petosemtamab (EGFR x LGR5 Mab) and ficerafusp (EGFR x TGF-β fusion protein) are both EGFR-targeting bispecifics, however differ in secondary targets and structural format. Petosemtamab and ficerafusp targeting first-line PD-L1-positive head and neck cancer in combination with KEYTRUDA. Recently, Merus announced Phase II clinical results showing that Petosemtamab combined with KEYTRUDA achieved nearly an 80% overall survival rate, and 63% confirmed overall response rate as a frontline treatment for select head and neck cancer patients, reinforcing its potential as a 'best-in-disease' therapy. These findings underscore the promise of this combination in establishing a new standard of care across both HPV-positive and HPV-negative first-line HNSCC.
Results from a Phase II study evaluating RYBREVANT for Adenoid Cystic Carcinoma (ACC) will be unveiled at ASCO 2025. ACC is a rare form of head and neck cancer with no established systemic treatment. ACC typically presents with locoregional disease and is treated with curative intent surgery and adjuvant radiation, but many patients develop locally recurrent/metastatic (R/M) disease even years later. Existing therapies often have poor tolerability, and the disease frequently develops resistance, underscoring the urgent need for more effective treatment options.
Among the several abstracts presented for Head and Neck Cancer, DelveInsight highlights a selection of abstracts that holds potential to drive meaningful clinical progress—ultimately aiming to improve the quality of life and prognosis for patients affected by this challenging cancer type.
|
Company/ Institute |
Drug |
Trial ID/ Acronym |
Patient Segment |
Phase |
Abstract ID |
Session type |
Abstract Title | |
|
Bristol Myers Squibb |
OPDIVO |
NCT03576417 (NIVOPOSTOP) |
HNSCC |
III |
#LBA2 |
Plenary Session |
NIVOPOSTOP (GORTEC 2018-01): A Phase III randomized trial of adjuvant nivolumab added to radio-chemotherapy in patients with resected head and neck squamous cell carcinoma at high risk of relapse. | |
|
Shanghai Miracogen |
Becotatug vedotin (MRG003) |
NCT05126719 |
Metastatic nasopharyngeal carcinoma |
II |
#LBA6005 |
Oral |
Becotatug vedotin vs. chemotherapy in pre-heavily treated advanced nasopharyngeal carcinoma: A randomized, controlled, multicenter, open-label study. | |
|
Sun Yat-sen University |
Toripalimab |
NCT04907370 |
Locoregionally advanced nasopharyngeal carcinoma |
III |
LBA6003 |
Oral |
PD-1 blockade with toripalimab incorporated into induction chemotherapy and radiotherapy with or without concurrent cisplatin in locoregionally advanced nasopharyngeal carcinoma (DIAMOND): A multicenter, non-inferiority, phase 3, randomized controlled trial. | |
|
Sichuan Kelun-Biotech Biopharmaceutical |
Tagitanlimab |
NCT05294172 |
R/M Nasopharyngeal Carcinoma |
III |
#6004 |
Oral |
Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, Phase III study. | |
|
Merus |
Petosemtamab (MCLA-158) |
NCT03526835 |
R/M HNSCC |
II |
#6024 |
Poster |
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 II trial. | |
|
Johnson & Johnson (Janssen Pharmaceuticals) |
RYBREVANT |
NCT05074940 |
R/M adenoid cystic carcinoma |
II |
#6101 |
Poster |
Amivantamab for recurrent/metastatic adenoid cystic carcinoma: A multicenter, single-arm, Phase II clinical trial. | |
|
Pfizer |
ADCETRIS + KEYTRUDA |
NCT04609566 |
HNSCC |
II |
#6015 |
Rapid Oral |
Phase II open-label study of brentuximab vedotin (BV) + pembrolizumab (pembro) in patients (pts) with treatment (tx)-naive metastatic head and neck squamous cell carcinoma (HNSCC). | |
|
BioAtla |
Ozuriftamab vedotin |
NCT03504488 |
HNSCC |
I/II |
#6048 |
Poster |
Phase II trial of ozuriftamab vedotin (BA3021), a conditionally binding ROR2-ADC, in patients with heavily pretreated squamous cell carcinoma of the head and neck. | |
|
Pfizer |
PF-08046054 (PDL1V) |
NCT05208762 |
R/M HNSCC |
I |
#6033 |
Poster |
Initial safety and efficacy of PDL1V (PF-08046054), a vedotin-based ADC targeting PD-L1, in combination with pembrolizumab in patients with recurrent or metastatic (R/M) HNSCC. | |
|
Bicara Therapeutics |
Ficerafusp alfa (BCA101) |
NCT04429542 |
R/M HNSCC |
I |
#6017 |
Rapid Oral |
Ficerafusp alfa with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: Updated results from an expansion cohort of an open-label, multicenter, Phase I/Ib trial. | |
Most of the head and neck tumors are histologically classified as squamous cell carcinomas (nearly 90%). The rising incidence of head and neck squamous cell carcinoma (HNSCC) is strongly associated with human papillomavirus (HPV) infection, with more than 90% of oropharyngeal cancer cases attributed to HPV in the US.