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39 NICE Draft Guidance: Rejects Keytruda In Head And Neck Cancer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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