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

  • ID: 5086946
  • Report
  • October 2020
  • Region: Global
  • 85 pages
  • Datamonitor Healthcare

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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.

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OVERVIEW
  • Latest key takeaways
DISEASE BACKGROUND
  • Definition
  • Patient segmentation
  • Risk factors
  • Symptoms
  • Diagnosis
TREATMENT
  • 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
EPIDEMIOLOGY
  • Incidence methodology
MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS
  • Supplemental Approvals Boost Opdivo And Gardasil 9, But Limit Beovu
  • NICE Draft Guidance: Rejects Keytruda In Head And Neck Cancer
  • EU Approvals: Keytruda Cleared For First-Line Head And Neck Cancer
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Regeneron Increases Stake In ISA Pharma, Plans Pivotal Study
  • Junshi, Merck KGaA To Explore Head And Neck Cancer Combo
  • Norgine Expands Portfolio With Azanta Acquisition
  • 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
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
DRUG ASSESSMENT MODEL

MARKET DYNAMICS

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
CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • ALX148 for Head and Neck Cancer (May 29, 2020)
  • Imfinzi for Head and Neck Cancer (May 29, 2020)
  • NBTXR3 (Drug) for Head and Neck Cancer (May 29, 2020)
  • Tipifarnib (Oncology) for Head and Neck Cancer (May 29, 2020)
  • 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)
  • ASP-1929 for Head and Neck Cancer (June 1, 2019)
  • SD-101 (TriSalus) for Head and Neck Cancer (June 1, 2019)
  • Keytruda for Head and Neck Cancer (May 31, 2019)
  • Ibrance for Head and Neck Cancer (May 15, 2019)
  • Imfinzi for Head and Neck Cancer (May 15, 2019)
  • Trodelvy for Head and Neck Cancer (April 29, 2019)
  • Opdivo for Head and Neck Cancer (April 25, 2019)
KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

BIBLIOGRAPHY
  • Prescription information
APPENDIX

List of Figures
  • Figure 1: TNM classifications for HNSCCs
  • Figure 2: Trends in incident cases of head and neck cancer, 2018-27
  • Figure 3: Overview of pipeline drugs for head and neck cancer in the US
  • Figure 4: Pipeline drugs for head and neck cancer, by company
  • Figure 5: Pipeline drugs for head and neck cancer, by drug type
  • Figure 6: Pipeline drugs for head and neck cancer, by classification
  • Figure 7: Probability of success in the head and neck cancer pipeline
  • Figure 8: Clinical trials in head and neck cancer
  • Figure 9: Top 10 drugs for clinical trials in head and neck cancer
  • Figure 10: Top 10 companies for clinical trials in head and neck cancer
  • Figure 11: Trial locations in head and neck cancer
  • Figure 12: Head and neck cancer trials status
  • Figure 13: Head and neck cancer trials sponsors, by phase
  • Figure 14: Datamonitor Healthcare’s drug assessment summary for head and neck cancer
  • Figure 15: Market dynamics in head and neck cancer
  • Figure 16: Future trends in head and neck cancer
  • Figure 17: Imfinzi for Head and Neck Cancer (May 29, 2020): Phase II - CheckRad-CD8 (w/Tremelimumab)
  • Figure 18: NBTXR3 (Drug) for Head and Neck Cancer (May 29, 2020): Phase I - NBTXR3-1100 (w/Nivolumab or Pembrolizumab)
  • Figure 19: Tipifarnib (Oncology) for Head and Neck Cancer (May 29, 2020): Phase II - RUN-HN (HRAS Mutations)
  • Figure 20: Debio 1143 for Head and Neck Cancer (September 30, 2019): Phase I/II - LA-SCCHN
  • Figure 21: Monalizumab for Head and Neck Cancer (September 30, 2019): Phase Ib/II - w/Cetuximab (US and EU)
  • Figure 22: ASP-1929 for Head and Neck Cancer (June 1, 2019): Phase I/IIa - w/PIT
  • Figure 23: Keytruda for Head and Neck Cancer (May 31, 2019): Phase III - KEYNOTE-048
  • Figure 24: Ibrance for Head and Neck Cancer (May 15, 2019): Phase II - PALATINUS (w/Cetuximab)
  • Figure 25: Imfinzi for Head and Neck Cancer (May 15, 2019): Phase III - EAGLE (+/-Tremelimumab)
  • Figure 26: Opdivo for Head and Neck Cancer (April 25, 2019): Phase II - CheckMate-714
  • Figure 27: Key upcoming events in head and neck cancer
List of Tables
  • Table 1: Head and neck cancer: ICD-10 diagnosis codes
  • Table 2: Recommended (Category 1) chemotherapy regimens for locally advanced disease, by origin of primary tumor
  • Table 3: Preferred systemic therapy regimens for very advanced disease, by origin of primary tumor
  • Table 4: Approved marketed drugs for head and neck cancer
  • Table 5: Incident cases of head and neck cancer, 2018-27
  • Table 6: Incident cases of head and neck cancer, by gender, 2018
  • Table 7: Marketed drugs for head and neck cancer
  • Table 8: Pipeline drugs for head and neck cancer in the US
  • Table 9: Historical global sales, by drug ($m), 2015-19
  • Table 10: Forecasted global sales, by drug ($m), 2020-24
  • Table 11: ALX148 for Head and Neck Cancer (May 29, 2020)
  • Table 12: Imfinzi for Head and Neck Cancer (May 29, 2020)
  • Table 13: NBTXR3 (Drug) for Head and Neck Cancer (May 29, 2020)
  • Table 14: Tipifarnib (Oncology) for Head and Neck Cancer (May 29, 2020)
  • Table 15: Bavencio for Head and Neck Cancer (March 13, 2020)
  • Table 16: Debio 1143 for Head and Neck Cancer (September 30, 2019)
  • Table 17: Monalizumab for Head and Neck Cancer (September 30, 2019)
  • Table 18: ABBV-368 for Head and Neck Cancer (September 4, 2019)
  • Table 19: Enoblituzumab for Head and Neck Cancer (July 10, 2019)
  • Table 20: ASP-1929 for Head and Neck Cancer (June 1, 2019)
  • Table 21: SD-101 (TriSalus) for Head and Neck Cancer (June 1, 2019)
  • Table 22: Keytruda for Head and Neck Cancer (May 31, 2019)
  • Table 23: Ibrance for Head and Neck Cancer (May 15, 2019)
  • Table 24: Imfinzi for Head and Neck Cancer (May 15, 2019)
  • Table 25: Trodelvy for Head and Neck Cancer (April 29, 2019)
  • Table 26: Opdivo for Head and Neck Cancer (April 25, 2019)
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