Head and Neck Cancer Disease Coverage Forecast and Market Analysis to 2024

Latest Key Takeaways

The publisher estimates that in 2018, there were 880,700 incident cases of head and neck cancer (HNC) worldwide, and expects that number to increase to 967,000 incident cases by 2027.

The majority of HNC diagnoses (75.2%) worldwide are in males, ranging from 64.9% to 76.3% across regions.

Though a heterogenous group of diseases, the overwhelming majority (90%) of HNCs are comprised of head and neck squamous cell carcinomas (HNSCCs).

Most HNC patients are treated with surgery, radiotherapy, and/or platinum-based chemotherapy.

Erbitux, once among the dominant branded systemic therapies for HNC, is being eclipsed by newer checkpoint inhibitors. Erbitux is approved for use in combination with radiation therapy to treat patients with unresectable HNSCC and both first- and subsequent-line recurrent/metastatic HNSCC as monotherapy and in combination with chemotherapy.

HNSCC tumors are highly immunogenic and have elevated expression of immune checkpoint modulators. As such, there has been much interest in the development of immunotherapies to allow for a more targeted treatment program.

The first immunotherapies approved for recurrent/metastatic HNSCCs are the checkpoint inhibitors Keytruda (for first and second line) and Opdivo (second line only). They have quickly established themselves as the most successful marketed drugs in this treatment setting. Keytruda is only approved for second-line patients with a tumor proportion score (TPS) of >50%, while Opdivo has no such restrictions.

Setbacks in the pipeline for treatments being developed for recurrent/metastatic HNSCCs, such as Imfinzi and Gilotrif, and, most recently, retifanlimab and enoblituzumab, have allowed Keytruda and Opdivo to consolidate their leading positions in this setting.

Keytruda is favored by US physicians, and, unlike Opdivo, is available for first- as well as second-line intervention for recurrent/metastatic HNSCC. However, Keytruda is not broadly available in the UK in the first-line setting due to a recent rejection by NICE, and Opdivo is typically favored by UK physicians in the second-line setting.

The ongoing Phase III CheckMate-651 trial seeks to gain approval for Opdivo for first-line recurrent/metastatic HNSCC, and challenge Keytruda in this setting.

Keytruda is in Phase III trials in the lucrative newly diagnosed, locally advanced HNSCC setting. KEYNOTE-412 is evaluating Keytruda combined with chemoradiation and as maintenance therapy for non-resectable HNSCC (a setting now rendered largely unchallenged since the suspension of Bavencio in JAVELIN Head and Neck 100), while KEYNOTE-689 is evaluating Keytruda as neoadjuvant therapy and in combination with standard-of-care adjuvant therapy for resectable HNSCC. Keytruda is also seeking its first approval for nasopharyngeal cancer, as KEYNOTE-122 is evaluating the drug versus standard-of-care chemotherapy for recurrent/metastatic nasopharyngeal cancer. Success in these areas would result in unrivaled availability for Keytruda across the HNC treatment landscape.

The other checkpoint inhibitor in Phase III development for newly diagnosed, locally advanced HNSCCs is Tecentriq. IMvoke010 is evaluating Tecentriq as single-agent adjuvant therapy for resectable, locally advanced HNSCC. IMvoke010 may offer an attractive alternative by using checkpoint inhibition as a monotherapy in locally advanced HNSCC, thereby avoiding the toxicity of platinum-based chemotherapy.

Immunotherapy approaches outside of checkpoint inhibitors, such as targeted T-cell therapy (TT10-EB-VST for EBV-positive nasopharyngeal cancer) and ICOS agonists (GSK3359609), are also in development for HNCs. Such advances look set to ensure the dominance of immunotherapy sales in HNC for the foreseeable future.