Market Spotlight: Small-Cell Lung Cancer (SCLC)
Market Spotlight: Small-Cell Lung Cancer (SCLC)
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This Market Spotlight report covers the small cell lung cancer market, comprising key pipeline and marketed drugs, recent events and analyst opinion, probability of success, clinical trials, upcoming and regulatory events, patent information, a 10-year disease incidence forecast, licensing and acquisition deals, and drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
This Market Spotlight report covers the small cell lung cancer market, comprising key pipeline and marketed drugs, recent events and analyst opinion, probability of success, clinical trials, upcoming and regulatory events, patent information, a 10-year disease incidence forecast, licensing and acquisition deals, and drug-specific revenue forecasts.
Key Takeaways
- Datamonitor Healthcare estimates that in 2019, there were 317,500 incident cases of small cell lung cancer (SCLC) worldwide, and forecasts that number to increase to 334,700 incident cases by 2028.
- Northern America is estimated to have the highest disease incidence of SCLC (10.43 per 100,000 people), while Africa has the lowest incidence (0.47 per 100,000 people).
- Approved drugs for SCLC focus on targets such as DNA, topoisomerase I, programmed death-1 receptor/programmed death ligands, and the immune system. These drugs are administered via the oral or intravenous routes.
- The majority of industry-sponsored drugs in active clinical development for SCLC are in Phase II, with only one drug in the NDA/BLA phase.
- Therapies in development for SCLC focus on a wide variety of targets. The majority of drugs in development for SCLC are administered via the intravenous route, with the remainder being oral, intratumoral, intramuscular, or subcutaneous formulations.
- High-impact upcoming events for drugs in the SCLC space comprise topline Phase I/II trial results for HPN328, topline Phase II/III trial results for Onivyde, topline Phase III trial results for Imfinzi, and an estimated PDUFA date for trilaciclib.
- The overall likelihood of approval of a Phase I solid tumors asset is 5.5%, and the average probability a drug advances from Phase III is 42.9%. Drugs, on average, take 9.7 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
- The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for SCLC have been in the early and mid-phases of development, with 89% of trials in Phase I–II, and only 11% in Phase III–IV.
- The US has a substantial lead in the number of SCLC clinical trials globally. The UK leads the major European markets, while China has the top spot in Asia.
- Clinical trial activity in the SCLC space is dominated by completed trials. Bristol Myers Squibb has the highest number of completed clinical trials for SCLC, with 44 trials.
- Bristol Myers Squibb leads industry sponsors with the highest overall number of clinical trials for SCLC, followed by Pfizer and GlaxoSmithKline
CONTENTS
6 OVERVIEW
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
9 TREATMENT
9 Chemotherapy
9 Radiotherapy
9 Immunotherapy
10 Surgery
10 Palliative procedures
11 EPIDEMIOLOGY
14 MARKETED DRUGS
17 PIPELINE DRUGS
26 RECENT EVENTS AND ANALYST OPINION
26 Zepzelca for SCLC (December 3, 2020)
27 Unituxin for SCLC (February 3, 2020)
28 Keytruda for SCLC (January 6, 2020)
30 HLX10 for SCLC (September 12, 2019)
31 Onivyde for SCLC (September 8, 2019)
34 KEY UPCOMING EVENTS
35 KEY REGULATORY EVENTS
35 Keeping Track: Submissions Galore Start The New Year; US FDA Clears New Indications For Enhertu, Xalkori
35 Ipsen CEO Outlines Strategy For Long-Term Success
35 US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal
35 Imfinzi Among Myriad Hopefuls Seeking Extended Indications In EU
35 Zepzelca Speeds To Accelerated Approval For SCLC
37 PROBABILITY OF SUCCESS
38 LICENSING AND ASSET ACQUISITION DEALS
38 Gilead Buys Pipeline-In-A-Product With $21bn Immunomedics Deal
38 Simcere Acquires China-Plus Rights To G1’s Trilaciclib
38 SciClone Gains China-Plus Rights To EpicentRx’s Novel Cancer Candidate
38 G1 Believes Boehringer Is Better Bet To Sell Trilaciclib
40 REVENUE OPPORTUNITY
41 CLINICAL TRIAL LANDSCAPE
42 Sponsors by status
43 Sponsors by phase
44 Recent events
46 BIBLIOGRAPHY
46 Prescription information
48 APPENDIX
LIST OF FIGURES
12 Figure 1: Trends in incident cases of SCLC, 2019–28
17 Figure 2: Overview of pipeline drugs for SCLC in the US
18 Figure 3: Pipeline drugs for SCLC, by company
18 Figure 4: Pipeline drugs for SCLC, by drug type
18 Figure 5: Pipeline drugs for SCLC, by classification
27 Figure 6: Zepzelca for SCLC (December 3, 2020): Phase III – ATLANTIS (w/Doxorubicin)
28 Figure 7: Unituxin for SCLC (February 3, 2020): Phase II/III – DISTINCT
30 Figure 8: Keytruda for SCLC (January 6, 2020): Phase III – KEYNOTE-604 (ES-SCLC)
33 Figure 9: Onivyde for SCLC (September 8, 2019): Phase II/III – RESILIENT
34 Figure 10: Key upcoming events in SCLC
37 Figure 11: Probability of success in the solid tumors pipeline
41 Figure 12: Clinical trials in SCLC
41 Figure 13: Top 10 drugs for clinical trials in SCLC
42 Figure 14: Top 10 companies for clinical trials in SCLC
42 Figure 15: Trial locations in SCLC
43 Figure 16: SCLC trials status
44 Figure 17: SCLC trial sponsors, by phase
LIST OF TABLES
11 Table 1: Incident cases of SCLC, 2019–28
13 Table 2: Incidence rates of SCLC
15 Table 3: Marketed drugs for SCLC
20 Table 4: Pipeline drugs for SCLC in the US
26 Table 5: Zepzelca for SCLC (December 3, 2020)
27 Table 6: Unituxin for SCLC (February 3, 2020)
29 Table 7: Keytruda for SCLC (January 6, 2020)
31 Table 8: HLX10 for SCLC (September 12, 2019)
32 Table 9: Onivyde for SCLC (September 8, 2019)
40 Table 10: Historical global sales, by drug ($m), 2015–19
40 Table 11: Forecasted global sales, by drug ($m), 2021–25
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