Head and Neck Cancer Disease Coverage Forecast and Market Analysis to 2024
Author: Tom Tyler
Publisher: Datamonitor Healthcare
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Latest key takeaways
- Datamonitor Healthcare 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.
- 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 SCCHN and both first- and subsequent-line recurrent/metastatic SCCHN 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 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.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Patient segmentation
10 Risk factors
11 Symptoms
11 Diagnosis
13 TREATMENT
13 Referral patterns
13 Standard of care by disease progression
13 Preferred systemic therapy regimens for locally advanced disease
14 Preferred systemic therapy regimens for very advanced disease
15 Approved marketed drugs
17 EPIDEMIOLOGY
17 Incidence methodology
21 MARKETED DRUGS
24 PIPELINE DRUGS
43 KEY REGULATORY EVENTS
43 NICE Draft Guidance: Rejects Keytruda In Head And Neck Cancer
43 EU Approvals: Keytruda Cleared For First-Line Head And Neck Cancer
43 Keytruda Swells In Head And Neck Cancer With First-Line Claim, Full Approval
44 PROBABILITY OF SUCCESS
45 LICENSING AND ASSET ACQUISITION DEALS
45 Tech Transfer Roundup: MD Anderson Inks Set of IO Deals Covering US, UK, Japan, China
45 Idera Pharmaceuticals Inc. and AbbVie Inc. Forged a Trial Collaboration to Study Combinations of ABBV368, Tilsotolimod,
Nab-Paclitaxel, and/or ABBV181
45 Well-Funded I-Mab Gains Chinese Rights to MacroGenics’ Enoblituzumab
45 Immuno-Oncology Firm Elicio Launches, Raises $30m in First Round
45 Immunomedics Inc. Granted Everest Medicines Ltd. Exclusive Rights to Develop, Register, and Sell Sacituzumab Govitecan in Asia
47 CLINICAL TRIAL LANDSCAPE
48 Sponsors by status
49 Sponsors by phase
50 Recent events
52 DRUG ASSESSMENT MODEL
55 MARKET DYNAMICS
56 FUTURE TRENDS
56 Standard of care shifting to immunotherapies
56 Keytruda’s dominant position bolstered by label expansions
56 Immunotherapies compete for approval in newly diagnosed HNSCC
57 Growing interest in combination immunotherapies in recurrent/metastatic HNSCC
57 Other novel approaches lag behind checkpoint inhibitors
58 CONSENSUS FORECASTS
59 RECENT EVENTS AND ANALYST OPINION
59 Bavencio for Head and Neck Cancer (March 13, 2020)
59 Debio 1143 for Head and Neck Cancer (September 30, 2019)
61 Monalizumab for Head and Neck Cancer (September 30, 2019)
63 ABBV-368 for Head and Neck Cancer (September 4, 2019)
64 Enoblituzumab for Head and Neck Cancer (July 10, 2019)
65 SD-101 for Head and Neck Cancer (June 1, 2019)
65 ASP-1929 for Head and Neck Cancer (June 1, 2019)
67 Keytruda for Head and Neck Cancer (May 31, 2019)
69 Imfinzi for Head and Neck Cancer (May 15, 2019)
71 Ibrance for Head and Neck Cancer (May 15, 2019)
73 Sacituzumab Govitecan for Head and Neck Cancer (April 29, 2019)
74 Opdivo for Head and Neck Cancer (April 25, 2019)
75 Imfinzi for Head and Neck Cancer (December 7, 2018)
77 Enoblituzumab for Head and Neck Cancer (November 9, 2018)
78 Tipifarnib for Head and Neck Cancer (October 22, 2018)
79 Keytruda for Head and Neck Cancer (October 22, 2018)
82 KEY UPCOMING EVENTS
83 KEY OPINION LEADER INSIGHTS
84 BIBLIOGRAPHY
84 Prescription information
85 APPENDIX
LIST OF FIGURES
10 Figure 1: TNM classifications for HNSCCs
19 Figure 2: Trends in incident cases of head and neck cancer, 2018–27
24 Figure 3: Overview of pipeline drugs for head and neck cancer in the US
24 Figure 4: Pipeline drugs for head and neck cancer, by company
25 Figure 5: Pipeline drugs for head and neck cancer, by drug type
25 Figure 6: Pipeline drugs for head and neck cancer, by classification
44 Figure 7: Probability of success in the head and neck cancer pipeline
47 Figure 8: Clinical trials in head and neck cancer
47 Figure 9: Top 10 drugs for clinical trials in head and neck cancer
48 Figure 10: Top 10 companies for clinical trials in head and neck cancer
48 Figure 11: Trial locations in head and neck cancer
49 Figure 12: Head and neck cancer trials status
50 Figure 13: Head and neck cancer trials sponsors, by phase
52 Figure 14: Datamonitor Healthcare’s drug assessment summary for head and neck cancer
55 Figure 15: Market dynamics in head and neck cancer
56 Figure 16: Future trends in head and neck cancer
61 Figure 17: Debio 1143 for Head and Neck Cancer: Phase I/II – LA-SCCHN (September 30, 2019)
63 Figure 18: Monalizumab for Head and Neck Cancer: Phase Ib/II – w/Cetuximab (US and EU) (September 30, 2019)
67 Figure 19: ASP-1929 for Head and Neck Cancer: Phase I/IIa – w/PIT (June 1, 2019)
69 Figure 20: Keytruda for Head and Neck Cancer: Phase III – KEYNOTE-048 (May 31, 2019)
71 Figure 21: Imfinzi for Head and Neck Cancer: Phase III – EAGLE (+/- Tremelimumab) (May 15, 2019)
73 Figure 22: Ibrance for Head and Neck Cancer: Phase II – PALATINUS (w/Cetuximab) (May 15, 2019)
75 Figure 23: Opdivo for Head and Neck Cancer: Phase II – CheckMate-714 (April 25, 2019)
77 Figure 24: Imfinzi for Head and Neck Cancer: Phase III – EAGLE (+/- Tremelimumab) (December 7, 2018)
78 Figure 25: Enoblituzumab for Head and Neck Cancer: Phase I – w/Pembrolizumab or MGA012 (Solid Tumors) (November 9, 2018)
81 Figure 26: Keytruda for Head and Neck Cancer: Phase III – KEYNOTE-048 (October 22, 2018)
82 Figure 27: Key upcoming events in head and neck cancer
LIST OF TABLES
9 Table 1: Head and neck cancer: ICD-10 diagnosis codes
14 Table 2: Recommended (category 1) chemotherapy regimens for locally advanced disease, by origin of primary tumor
15 Table 3: Preferred systemic therapy regimens for very advanced disease, by origin of primary tumor
16 Table 4: Approved marketed drugs for head and neck cancer
18 Table 5: Incident cases of head and neck cancer, 2018–27
20 Table 6: Incident cases of head and neck cancer, by gender, 2018
22 Table 7: Marketed drugs for head and neck cancer
27 Table 8: Pipeline drugs for head and neck cancer in the US
58 Table 9: Historical global sales, by drug ($m), 2015–19
58 Table 10: Forecasted global sales, by drug ($m), 2020–24
59 Table 11: Bavencio for Head and Neck Cancer (March 13, 2020)
60 Table 12: Debio 1143 for Head and Neck Cancer (September 30, 2019)
62 Table 13: Monalizumab for Head and Neck Cancer (September 30, 2019)
63 Table 14: ABBV-368 for Head and Neck Cancer (September 4, 2019)
64 Table 15: Enoblituzumab for Head and Neck Cancer (July 10, 2019)
65 Table 16: SD-101 for Head and Neck Cancer (June 1, 2019)
66 Table 17: ASP-1929 for Head and Neck Cancer (June 1, 2019)
68 Table 18: Keytruda for Head and Neck Cancer (May 31, 2019)
70 Table 19: Imfinzi for Head and Neck Cancer (May 15, 2019)
72 Table 20: Ibrance for Head and Neck Cancer (May 15, 2019)
73 Table 21: Sacituzumab Govitecan for Head and Neck Cancer (April 29, 2019)
74 Table 22: Opdivo for Head and Neck Cancer (April 25, 2019)
76 Table 23: Imfinzi for Head and Neck Cancer (December 7, 2018)
77 Table 24: Enoblituzumab for Head and Neck Cancer (November 9, 2018)
79 Table 25: Tipifarnib for Head and Neck Cancer (October 22, 2018)
80 Table 26: Keytruda for Head and Neck Cancer (October 22, 2018)
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