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 2017, there were 310,300 incident cases of small cell lung cancer (SCLC) worldwide, and forecasts that number to increase to 339,500 incident cases by 2026.
- 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. 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 Pegzilarginase, topline Phase II/III trial results for Unituxin, and topline Phase III trial results for Zepsyre and Keytruda.
- 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 39.9%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
- There have been 14 licensing and asset acquisition deals involving SCLC drugs during 2014–19. The largest deal was the $356m licensing agreement made in 2017 between CytRx and NantCell for the exclusive rights to develop and market aldoxorubicin.
- 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 EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the SCLC space is dominated by completed trials. GlaxoSmithKline and Pfizer have the highest number of completed clinical trials for SCLC, with 42 and 41 trials, respectively.
- Pfizer leads industry sponsors with the highest overall number of clinical trials for SCLC, followed by GlaxoSmithKline and BristolMyers Squibb.
CONTENTS
7 OVERVIEW
8 KEY TAKEAWAYS
9 DISEASE BACKGROUND
10 TREATMENT
10 Chemotherapy
10 Radiotherapy
10 Immunotherapy
11 Surgery
11 Palliative procedures
12 EPIDEMIOLOGY
16 MARKETED DRUGS
19 PIPELINE DRUGS
26 RECENT EVENTS AND ANALYST OPINION
26 HLX10 for SCLC (September 12, 2019)
27 Onivyde for SCLC (September 8, 2019)
28 Imfinzi for SCLC (June 27, 2019)
30 Zepsyre for SCLC (June 1, 2019)
32 Sacituzumab Govitecan for SCLC (April 29, 2019)
33 Opdivo for SCLC (April 11, 2019)
35 Keytruda for SCLC (April 1, 2019)
37 Zepsyre for SCLC (March 25, 2019)
38 Beleodaq for SCLC (January 17, 2019)
39 Rova-T for SCLC (December 5, 2018)
40 Opdivo for SCLC (November 26, 2018)
42 Trilaciclib for SCLC (November 26, 2018)
44 Trilaciclib for SCLC (October 21, 2018)
46 Opdivo for SCLC (October 12, 2018)
48 Tecentriq for SCLC (September 25, 2018)
49 Opdivo for SCLC (August 16, 2018)
51 KEY UPCOMING EVENTS
52 KEY REGULATORY EVENTS
52 Tecentriq Nod For SCLC
52 CHMP Recommendation For Roche’s Tecentriq In Expanded Patient Population
52 Merck’s Keytruda Nabs First SCLC Approval
52 France OKs Early Access To Tecentriq For SCLC Pending EU Approval
53 PROBABILITY OF SUCCESS
54 LICENSING AND ASSET ACQUISITION DEALS
54 Luye Licenses Novel Oncology Drug From Pharmamar
55 PARENT PATENTS
56 REVENUE OPPORTUNITY
57 CLINICAL TRIAL LANDSCAPE
58 Sponsors by status
59 Sponsors by phase
60 Recent events
62 BIBLIOGRAPHY
62 Prescription information
63 APPENDIX
LIST OF FIGURES
14 Figure 1: Trends in incident cases of SCLC, 2017–26
19 Figure 2: Overview of pipeline drugs for SCLC in the US
19 Figure 3: Pipeline drugs for SCLC, by company
20 Figure 4: Pipeline drugs for SCLC, by drug type
20 Figure 5: Pipeline drugs for SCLC, by classification
28 Figure 6: Onivyde for SCLC (September 8, 2019): Phase II/III – RESILIENT
30 Figure 7: Imfinzi for SCLC (June 27, 2019): Phase III – CASPIAN
32 Figure 8: Zepsyre for SCLC (June 1, 2019): Phase II – Solid Tumors (Relapsed SCLC; EU/US)
35 Figure 9: Opdivo for SCLC (April 11, 2019): Phase III – CheckMate-451 (Maintenance)
37 Figure 10: Keytruda for SCLC (April 1, 2019): Phase Ib – KEYNOTE-028 (PD-L1 Positive Tumors), Phase II – KEYNOTE-158
42 Figure 11: Opdivo for SCLC (November 26, 2018): Phase III – CheckMate-451 (Maintenance)
44 Figure 12: Trilaciclib for SCLC (November 26, 2018): Phase II – w/Tecentriq+Chemotherapy
46 Figure 13: Trilaciclib for SCLC (October 21, 2018): Phase Ib/IIa – w/Etoposide/Carboplatin (02)
48 Figure 14: Opdivo for SCLC (October 12, 2018): Phase III – CheckMate 331
49 Figure 15: Tecentriq for SCLC (September 25, 2018): Phase I/III – IMpower133 (Carboplatin + Etoposide, ES-SCLC)
51 Figure 16: Key upcoming events in SCLC
53 Figure 17: Probability of success in the SCLC pipeline
54 Figure 18: Licensing and asset acquisition deals in SCLC, 2014–19
55 Figure 19: Parent patents in SCLC
57 Figure 20: Clinical trials in SCLC
57 Figure 21: Top 10 drugs for clinical trials in SCLC
58 Figure 22: Top 10 companies for clinical trials in SCLC
58 Figure 23: Trial locations in SCLC
59 Figure 24: SCLC trials status
60 Figure 25: SCLC trial sponsors, by phase
LIST OF TABLES
13 Table 1: Incident cases of SCLC, 2017–26
15 Table 2: Incidence rates of SCLC, 2017–26
17 Table 3: Marketed drugs for SCLC
21 Table 4: Pipeline drugs for SCLC in the US
26 Table 5: HLX10 for SCLC (September 12, 2019)
27 Table 6: Onivyde for SCLC (September 8, 2019)
29 Table 7: Imfinzi for SCLC (June 27, 2019)
30 Table 8: Zepsyre for SCLC (June 1, 2019)
33 Table 9: Sacituzumab Govitecan for SCLC (April 29, 2019)
34 Table 10: Opdivo for SCLC (April 11, 2019)
36 Table 11: Keytruda for SCLC (April 1, 2019)
38 Table 12: Zepsyre for SCLC (March 25, 2019)
39 Table 13: Beleodaq for SCLC (January 17, 2019)
40 Table 14: Rova-T for SCLC (December 5, 2018)
41 Table 15: Opdivo for SCLC (November 26, 2018)
42 Table 16: Trilaciclib for SCLC (November 26, 2018)
45 Table 17: Trilaciclib for SCLC (October 21, 2018)
47 Table 18: Opdivo for SCLC (October 12, 2018)
48 Table 19: Tecentriq for SCLC (September 25, 2018)
50 Table 20: Opdivo for SCLC (August 16, 2018)
56 Table 21: Historical global sales, by drug ($m), 2014–18
56 Table 22: Forecasted global sales, by drug ($m), 2019–23
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