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 men, 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 immune checkpoint inhibitors (ICIs) 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 advanced HNSCCs, such as Imfinzi and Gilotrif, and – most recently – Bavencio, 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. 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 ICI 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.
- Other ICIs such as monalizumab, which inhibits NKG2A, are also in development for HNCs. Continued development and potential approvals of additional immune checkpoint therapies are set to ensure the dominance of immuno-oncology agents 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
16 Preferred systemic therapy regimens for very advanced disease
16 Approved marketed drugs
18 EPIDEMIOLOGY
18 Incidence methodology
22 MARKETED DRUGS
25 PIPELINE DRUGS
39 KEY REGULATORY EVENTS
39 First Approval For Rakuten Medical
39 Supplemental Approvals Boost Opdivo And Gardasil 9, But Limit Beovu
39 NICE Draft Guidance: Rejects Keytruda In Head And Neck Cancer
40 PROBABILITY OF SUCCESS
41 LICENSING AND ASSET ACQUISITION DEALS
41 China Grand Alliance With eTheRNA Follows Equity Investment
41 Gilead Buys Pipeline-In-A-Product With $21bn Immunomedics Deal
41 Regeneron Increases Stake In ISA Pharma, Plans Pivotal Study
41 Junshi, Merck KGaA To Explore Head And Neck Cancer Combo
42 Norgine Expands Portfolio With Azanta Acquisition
42 Tech Transfer Roundup: MD Anderson Inks Set of IO Deals Covering US, UK, Japan, China
43 CLINICAL TRIAL LANDSCAPE
44 Sponsors by status
45 Sponsors by phase
46 Recent events
47 DRUG ASSESSMENT MODEL
50 MARKET DYNAMICS
51 FUTURE TRENDS
51 Standard of care shifting to immunotherapies
51 Keytruda’s dominant position bolstered by label expansions
51 Immunotherapies compete for approval in newly diagnosed HNSCC
52 Immune checkpoint doublets see mixed fortunes
52 Other pipeline drugs lag behind checkpoint inhibitors
54 CONSENSUS FORECASTS
56 RECENT EVENTS AND ANALYST OPINION
56 mRNA-4157 for Head and Neck Cancer (November 11, 2020)
57 Bavencio for Head and Neck Cancer (September 19, 2020)
59 SNS-301 for Head and Neck Cancer (September 18, 2020)
60 ALX148 for Head and Neck Cancer (May 29, 2020)
61 Imfinzi for Head and Neck Cancer (May 29, 2020)
62 NBTXR3 (Drug) for Head and Neck Cancer (May 29, 2020)
64 Tipifarnib (Oncology) for Head and Neck Cancer (May 29, 2020)
66 Bavencio for Head and Neck Cancer (March 13, 2020)
67 Debio 1143 for Head and Neck Cancer (September 30, 2019)
69 Monalizumab for Head and Neck Cancer (September 30, 2019)
71 ABBV-368 for Head and Neck Cancer (September 4, 2019)
72 Enoblituzumab for Head and Neck Cancer (July 10, 2019)
73 ASP-1929 for Head and Neck Cancer (June 1, 2019)
74 SD-101 (TriSalus) for Head and Neck Cancer (June 1, 2019)
76 KEY UPCOMING EVENTS
77 KEY OPINION LEADER INSIGHTS
78 BIBLIOGRAPHY
78 Prescription information
79 APPENDIX
LIST OF FIGURES
10 Figure 1: TNM classifications for HNSCCs
20 Figure 2: Trends in incident cases of head and neck cancer, 2018–27
25 Figure 3: Overview of pipeline drugs for head and neck cancer in the US
25 Figure 4: Pipeline drugs for head and neck cancer, by company
26 Figure 5: Pipeline drugs for head and neck cancer, by drug type
26 Figure 6: Pipeline drugs for head and neck cancer, by classification
40 Figure 7: Probability of success in the head and neck cancer pipeline
43 Figure 8: Clinical trials in head and neck cancer
43 Figure 9: Top 10 drugs for clinical trials in head and neck cancer
44 Figure 10: Top 10 companies for clinical trials in head and neck cancer
44 Figure 11: Trial locations in head and neck cancer
45 Figure 12: Head and neck cancer trials status
46 Figure 13: Head and neck cancer trials sponsors, by phase
47 Figure 14: Datamonitor Healthcare’s drug assessment summary for head and neck cancer
50 Figure 15: Market dynamics in head and neck cancer
51 Figure 16: Future trends in head and neck cancer
57 Figure 17: mRNA-4157 for Head and Neck Cancer (November 11, 2020): Phase I – KEYNOTE-603 (w/Pembrolizumab)
59 Figure 18: Bavencio for Head and Neck Cancer (September 19, 2020): Phase III – JAVELIN HEAD AND NECK 100
62 Figure 19: Imfinzi for Head and Neck Cancer (May 29, 2020): Phase II – CheckRad-CD8 (w/Tremelimumab)
64 Figure 20: NBTXR3 (Drug) for Head and Neck Cancer (May 29, 2020): Phase I – NBTXR3-1100 (w/Nivolumab or Pembrolizumab)
66 Figure 21: Tipifarnib (Oncology) for Head and Neck Cancer (May 29, 2020): Phase II – RUN-HN (HRAS Mutations)
69 Figure 22: Debio 1143 for Head and Neck Cancer (September 30, 2019): Phase I/II – LA-SCCHN
71 Figure 23: Monalizumab for Head and Neck Cancer (September 30, 2019): Phase Ib/II – w/Cetuximab (US and EU)
74 Figure 24: ASP-1929 for Head and Neck Cancer (June 1, 2019): Phase I/IIa – w/PIT
76 Figure 25: Key upcoming events in head and neck cancer
LIST OF TABLES
9 Table 1: Head and neck cancer: ICD-10 diagnosis codes
15 Table 2: Recommended (Category 1) chemotherapy regimens for locally advanced disease, by origin of primary tumor
16 Table 3: Preferred systemic therapy regimens for very advanced disease, by origin of primary tumor
17 Table 4: Approved marketed drugs for head and neck cancer
19 Table 5: Incident cases of head and neck cancer, 2018–27
21 Table 6: Incident cases of head and neck cancer, by gender, 2018
23 Table 7: Marketed drugs for head and neck cancer
27 Table 8: Pipeline drugs for head and neck cancer in the US
54 Table 9: Historical global sales, by drug ($m), 2015–19
54 Table 10: Forecasted global sales, by drug ($m), 2020–24
56 Table 11: mRNA-4157 for Head and Neck Cancer (November 11, 2020)
58 Table 12: Bavencio for Head and Neck Cancer (September 19, 2020)
59 Table 13: SNS-301 for Head and Neck Cancer (September 18, 2020)
60 Table 14: ALX148 for Head and Neck Cancer (May 29, 2020)
61 Table 15: Imfinzi for Head and Neck Cancer (May 29, 2020)
63 Table 16: NBTXR3 (Drug) for Head and Neck Cancer (May 29, 2020)
65 Table 17: Tipifarnib (Oncology) for Head and Neck Cancer (May 29, 2020)
67 Table 18: Bavencio for Head and Neck Cancer (March 13, 2020)
68 Table 19: Debio 1143 for Head and Neck Cancer (September 30, 2019)
70 Table 20: Monalizumab for Head and Neck Cancer (September 30, 2019)
71 Table 21: ABBV-368 for Head and Neck Cancer (September 4, 2019)
72 Table 22: Enoblituzumab for Head and Neck Cancer (July 10, 2019)
73 Table 23: ASP-1929 for Head and Neck Cancer (June 1, 2019)
75 Table 24: SD-101 (TriSalus) for Head and Neck Cancer (June 1, 2019)
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