The "Head and Neck Cancer Disease Coverage Forecast and Market Analysis to 2024" report has been added to ResearchAndMarkets.com's offering.
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 squamous cell carcinomas of the head and neck (HNSCCs). Most HNC patients are treated with surgery, radiotherapy, and/or platinum-based 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 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, the suspension of JAVELIN 100 (which tested Bavencio combined with chemoradiotherapy for non-resectable HNSCC), have allowed Keytruda and Opdivo to consolidate their leading positions in this setting.
Keytruda is favored by American 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 British 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, 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. KEYNOTE-122 is evaluating Keytruda 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.
Key Topics Covered:
- Latest key takeaways
3. DISEASE BACKGROUND
- Patient segmentation
- Risk factors
- Referral patterns
- Standard of care by disease progression
- Preferred systemic therapy regimens for locally advanced disease
- Preferred systemic therapy regimens for very advanced disease
- Approved marketed drugs
- Incidence methodology
6. MARKETED DRUGS
7. PIPELINE DRUGS
8. KEY REGULATORY EVENTS
- NICE Draft Guidance: Rejects Keytruda In Head And Neck Cancer
- EU Approvals: Keytruda Cleared For First-Line Head And Neck Cancer
- Keytruda Swells In Head And Neck Cancer With First-Line Claim, Full Approval
9. PROBABILITY OF SUCCESS
10. LICENSING AND ASSET ACQUISITION DEALS
- Tech Transfer Roundup: MD Anderson Inks Set of IO Deals Covering US, UK, Japan, China
- Idera Pharmaceuticals Inc. and AbbVie Inc. Forged a Trial Collaboration to Study Combinations of ABBV368, Tilsotolimod,
- Nab-Paclitaxel, and/or ABBV181
- Well-Funded I-Mab Gains Chinese Rights to MacroGenics' Enoblituzumab
- Immuno-Oncology Firm Elicio Launches, Raises $30m in First Round
- Immunomedics Inc. Granted Everest Medicines Ltd. Exclusive Rights to Develop, Register, and Sell Sacituzumab Govitecan in Asia
11. CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
12. DRUG ASSESSMENT MODEL
13. MARKET DYNAMICS
14. FUTURE TRENDS
- Standard of care shifting to immunotherapies
- Keytruda's dominant position bolstered by label expansions
- Immunotherapies compete for approval in newly diagnosed HNSCC
- Growing interest in combination immunotherapies in recurrent/metastatic HNSCC
- Other novel approaches lag behind checkpoint inhibitors
15. CONSENSUS FORECASTS
16. RECENT EVENTS AND ANALYST OPINION
- Bavencio for Head and Neck Cancer (March 13, 2020)
- Debio 1143 for Head and Neck Cancer (September 30, 2019)
- Monalizumab for Head and Neck Cancer (September 30, 2019)
- ABBV-368 for Head and Neck Cancer (September 4, 2019)
- Enoblituzumab for Head and Neck Cancer (July 10, 2019)
- SD-101 for Head and Neck Cancer (June 1, 2019)
- ASP-1929 for Head and Neck Cancer (June 1, 2019)
- Keytruda for Head and Neck Cancer (May 31, 2019)
- Imfinzi for Head and Neck Cancer (May 15, 2019)
- Ibrance for Head and Neck Cancer (May 15, 2019)
- Sacituzumab Govitecan for Head and Neck Cancer (April 29, 2019)
- Opdivo for Head and Neck Cancer (April 25, 2019)
- Imfinzi for Head and Neck Cancer (December 7, 2018)
- Enoblituzumab for Head and Neck Cancer (November 9, 2018)
- Tipifarnib for Head and Neck Cancer (October 22, 2018)
- Keytruda for Head and Neck Cancer (October 22, 2018)
17. KEY UPCOMING EVENTS
18. KEY OPINION LEADER INSIGHTS
- Prescription information
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