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 two drugs 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 and Phase III trial results, an expected PDUFA date, and an estimated European supplemental approval decision.
- The overall likelihood of approval of a Phase I solid tumors asset is 5.6%, and the average probability a drug advances from Phase III is 42.5%. Drugs, on average, take 9.4 years from Phase I to approval, compared to 9.2 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 88% of trials in Phase I–II, and only 12% 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 Japan has the top spot in Asia.
- Clinical trial activity in the SCLC space is dominated by completed trials. Bristol Myers Squibb, Pfizer, and GlaxoSmithKline have the highest number of completed clinical trials for SCLC, with 42 trials each.
- Bristol Myers Squibb leads industry sponsors with the highest overall number of clinical trials for SCLC, followed by Pfizer and GlaxoSmithKline.
CONTENTS
7 OVERVIEW
8 KEY TAKEAWAYS
9 DISEASE BACKGROUND
10 TREATMENT
10 Chemotherapy
10 Radiotherapy
10 Immunotherapy
11 Surgery
11 Palliative procedures
12 EPIDEMIOLOGY
15 MARKETED DRUGS
18 PIPELINE DRUGS
26 RECENT EVENTS AND ANALYST OPINION
26 Unituxin for SCLC (February 3, 2020)
27 Keytruda for SCLC (January 6, 2020)
28 HLX10 for SCLC (September 12, 2019)
29 Onivyde for SCLC (September 8, 2019)
31 Imfinzi for SCLC (June 27, 2019)
33 Zepsyre for SCLC (June 1, 2019)
35 Trodelvy for SCLC (April 29, 2019)
36 Opdivo for SCLC (April 11, 2019)
38 Keytruda for SCLC (April 1, 2019)
40 Zepsyre for SCLC (March 25, 2019)
41 Beleodaq for SCLC (January 17, 2019)
42 Rova-T for SCLC (December 5, 2018)
43 Opdivo for SCLC (November 26, 2018)
45 Trilaciclib for SCLC (November 26, 2018)
48 KEY UPCOMING EVENTS
49 KEY REGULATORY EVENTS
49 NICE Rejects Tecentriq For SCLC In England
49 Roche’s Tecentriq Gets Another Indication In India But Pricing Hurts
49 AstraZeneca Gets Fast Imfinzi Review For SCLC
49 Tecentriq Nod For SCLC
50 CHMP Recommendation For Roche’s Tecentriq In Expanded Patient Population
50 Merck’s Keytruda Nabs First SCLC Approval
50 France OKs Early Access To Tecentriq For SCLC Pending EU Approval
51 PROBABILITY OF SUCCESS
52 LICENSING AND ASSET ACQUISITION DEALS
52 Jazz Acquires US Rights To PharmaMar Lung Cancer Candidate
52 Luye Licenses Novel Oncology Drug From Pharmamar
53 REVENUE OPPORTUNITY
54 CLINICAL TRIAL LANDSCAPE
55 Sponsors by status
56 Sponsors by phase
57 Recent events
59 BIBLIOGRAPHY
59 Prescription information
61 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in incident cases of SCLC, 2019–28
18 Figure 2: Overview of pipeline drugs for SCLC in the US
19 Figure 3: Pipeline drugs for SCLC, by company
19 Figure 4: Pipeline drugs for SCLC, by drug type
19 Figure 5: Pipeline drugs for SCLC, by classification
27 Figure 6: Unituxin for SCLC (February 3, 2020): Phase II/III – DISTINCT
28 Figure 7: Keytruda for SCLC (January 6, 2020): Phase III – KEYNOTE-604 (ES-SCLC)
31 Figure 8: Onivyde for SCLC (September 8, 2019): Phase II/III – RESILIENT
33 Figure 9: Imfinzi for SCLC (June 27, 2019): Phase III – CASPIAN
35 Figure 10: Zepsyre for SCLC (June 1, 2019): Phase II – Solid Tumors (Relapsed SCLC; EU/US)
38 Figure 11: Opdivo for SCLC (April 11, 2019): Phase III – CheckMate-451 (Maintenance)
40 Figure 12: Keytruda for SCLC (April 1, 2019): Phase Ib – KEYNOTE-028 (PD-L1 Positive Tumors), Phase II – KEYNOTE-158
45 Figure 13: Opdivo for SCLC (November 26, 2018): Phase III – CheckMate-451 (Maintenance)
47 Figure 14: Trilaciclib for SCLC (November 26, 2018): Phase II – w/Tecentriq+Chemotherapy
48 Figure 15: Key upcoming events in SCLC
51 Figure 16: Probability of success in the SCLC pipeline
54 Figure 17: Clinical trials in SCLC
54 Figure 18: Top 10 drugs for clinical trials in SCLC
55 Figure 19: Top 10 companies for clinical trials in SCLC
55 Figure 20: Trial locations in SCLC
56 Figure 21: SCLC trials status
57 Figure 22: SCLC trial sponsors, by phase
LIST OF TABLES
12 Table 1: Incident cases of SCLC, 2019–28
14 Table 2: Incidence rates of SCLC
16 Table 3: Marketed drugs for SCLC
21 Table 4: Pipeline drugs for SCLC in the US
26 Table 5: Unituxin for SCLC (February 3, 2020)
27 Table 6: Keytruda for SCLC (January 6, 2020)
29 Table 7: HLX10 for SCLC (September 12, 2019)
30 Table 8: Onivyde for SCLC (September 8, 2019)
32 Table 9: Imfinzi for SCLC (June 27, 2019)
33 Table 10: Zepsyre for SCLC (June 1, 2019)
36 Table 11: Trodelvy for SCLC (April 29, 2019)
37 Table 12: Opdivo for SCLC (April 11, 2019)
39 Table 13: Keytruda for SCLC (April 1, 2019)
41 Table 14: Zepsyre for SCLC (March 25, 2019)
42 Table 15: Beleodaq for SCLC (January 17, 2019)
43 Table 16: Rova-T for SCLC (December 5, 2018)
44 Table 17: Opdivo for SCLC (November 26, 2018)
45 Table 18: Trilaciclib for SCLC (November 26, 2018)
53 Table 19: Historical global sales, by drug ($m), 2015–19
53 Table 20: Forecasted global sales, by drug ($m), 2020–24
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