DUBLIN–(BUSINESS WIRE)–The “Disease Analysis: Head and Neck Cancer” report has been added to ResearchAndMarkets.com’s offering.
The report estimated 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 second-line recurrent/metastatic HNSCC as a single agent and alongside 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 targeted treatment programs.
- The first immunotherapies approved for recurrent/metastatic HNSCCs are anti-PD-1/PD-L1 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.
- Numerous setbacks in pipeline therapies for advanced HNSCCs, such as Imfinzi, Gilotrif, Bavencio, retifanlimab, and enoblituzumab, have allowed Keytruda and Opdivo to consolidate their leading positions in this setting. More generally, these failures reflect the unusually challenging R&D sphere in HNC, where the average probability a drug candidate advances from Phase III is 25%, significantly lower than the average of 47.6% in oncology as a whole.
- Keytruda is favored by US physicians, and, unlike Opdivo, is available for first- as well as second-line intervention for recurrent/metastatic HNSCC. A reversal of earlier negative NICE guidance has also led to widespread use in the UK.
- 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 potentially lucrative 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 the JAVELIN Head and Neck 100 trial. KEYNOTE-689 is evaluating Keytruda as a 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 PD-1/PD-L1 antibody in Phase III development for newly diagnosed, locally advanced HNSCC 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.
- Monalizumab, an experimental checkpoint inhibitor, binds to the novel immune checkpoint target NKG2A. 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.
- Though not threatening the dominance of ICIs in the treatment algorithm, experimental treatments such as the cytotoxic small molecule xevinapant and the farnesyltransferase inhibitor tipifarnib may provide therapeutic options for patients in hard-to-treat niches.
Key Topics Covered:
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
- Additional Keytruda Indication Among Latest China Approvals
- First Approval For Rakuten Medical
- Supplemental Approvals Boost Opdivo And Gardasil 9, But Limit Beovu
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Merck KGaA Bags Exclusive Rights To Develop, Sell Debiopharm’s Xevinapant
- Nektar Finances Trial Via Capital, Collaboration With SFJ
- China Grand Alliance With eTheRNA Follows Equity Investment
- Gilead Buys Pipeline-In-A-Product With $21bn Immunomedics Deal
- 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
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 locoregional HNSCC
- Poor trial results jeopardize development of immune checkpoint doublets
- Other pipeline drug classes lag behind checkpoint inhibitors
CONSENSUS FORECASTS
RECENT EVENTS AND ANALYST OPINION
- Imfinzi for Head and Neck Cancer (February 5, 2021)
- mRNA-4157 for Head and Neck Cancer (November 11, 2020)
- Bavencio for Head and Neck Cancer (September 19, 2020)
- SNS-301 for Head and Neck Cancer (September 18, 2020)
- 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)
- Monalizumab for Head and Neck Cancer (September 30, 2019)
- Xevinapant for Head and Neck Cancer (September 30, 2019)
KEY UPCOMING EVENTS
KEY OPINION LEADER INSIGHTS
BIBLIOGRAPHY
- Prescription information
APPENDIX
For more information about this report visit https://www.researchandmarkets.com/r/3ydrb5
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