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, with three 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 trial results for pegzilarginase, topline Phase II/III trial results for Unituxin, and topline Phase III trial results as well as expected PDUFA dates for Zepsyre and Imfinzi.
- The overall likelihood of approval of a Phase I solid tumors asset is 5.7%, and the average probability a drug advances from Phase III is 41.9%. Drugs, on average, take 9.4 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
- There have been 15 licensing and asset acquisition deals involving SCLC drugs during 2015–20. The largest deal was the $1,000m exclusive license agreement made in December 2019 between Jazz Pharmaceuticals and PharmaMar, under which Jazz Pharmaceuticals will obtain the US commercial rights to PharmaMar’s relapsed SCLC candidate, Zepsyre (lurbinectedin).
- 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 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
16 MARKETED DRUGS
19 PIPELINE DRUGS
26 RECENT EVENTS AND ANALYST OPINION
26 Keytruda for SCLC (January 6, 2020)
27 HLX10 for SCLC (September 12, 2019)
28 Onivyde for SCLC (September 8, 2019)
30 Imfinzi for SCLC (June 27, 2019)
32 Zepsyre for SCLC (June 1, 2019)
34 Sacituzumab Govitecan for SCLC (April 29, 2019)
35 Opdivo for SCLC (April 11, 2019)
37 Keytruda for SCLC (April 1, 2019)
39 Zepsyre for SCLC (March 25, 2019)
40 Beleodaq for SCLC (January 17, 2019)
41 Rova-T for SCLC (December 5, 2018)
42 Opdivo for SCLC (November 26, 2018)
44 Trilaciclib for SCLC (November 26, 2018)
Published on 31 January 2020
Market Spotlight : Small cell lung cancer (SCLC) 4
© Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed
46 Trilaciclib for SCLC (October 21, 2018)
48 Opdivo for SCLC (October 12, 2018)
50 Tecentriq for SCLC (September 25, 2018)
51 Opdivo for SCLC (August 16, 2018)
53 KEY UPCOMING EVENTS
54 KEY REGULATORY EVENTS
54 NICE Rejects Tecentriq For SCLC In England
54 Roche’s Tecentriq Gets Another Indication In India But Pricing Hurts
54 AstraZeneca Gets Fast Imfinzi Review For SCLC
54 Tecentriq Nod For SCLC
55 CHMP Recommendation For Roche’s Tecentriq In Expanded Patient Population
55 Merck’s Keytruda Nabs First SCLC Approval
55 France OKs Early Access To Tecentriq For SCLC Pending EU Approval
56 PROBABILITY OF SUCCESS
57 LICENSING AND ASSET ACQUISITION DEALS
57 Jazz Acquires US Rights To PharmaMar Lung Cancer Candidate
57 Luye Licenses Novel Oncology Drug From Pharmamar
59 PARENT PATENTS
60 REVENUE OPPORTUNITY
61 CLINICAL TRIAL LANDSCAPE
62 Sponsors by status
63 Sponsors by phase
64 Recent events
66 BIBLIOGRAPHY
66 Prescription information
67 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
27 Figure 6: Keytruda for SCLC (January 6, 2020): Phase III – KEYNOTE-604 (ES-SCLC)
30 Figure 7: Onivyde for SCLC (September 8, 2019): Phase II/III – RESILIENT
32 Figure 8: Imfinzi for SCLC (June 27, 2019): Phase III – CASPIAN
34 Figure 9: Zepsyre for SCLC (June 1, 2019): Phase II – Solid Tumors (Relapsed SCLC; EU/US)
37 Figure 10: Opdivo for SCLC (April 11, 2019): Phase III – CheckMate-451 (Maintenance)
39 Figure 11: Keytruda for SCLC (April 1, 2019): Phase Ib – KEYNOTE-028 (PD-L1 Positive Tumors), Phase II – KEYNOTE-158
44 Figure 12: Opdivo for SCLC (November 26, 2018): Phase III – CheckMate-451 (Maintenance)
46 Figure 13: Trilaciclib for SCLC (November 26, 2018): Phase II – w/Tecentriq+Chemotherapy
48 Figure 14: Trilaciclib for SCLC (October 21, 2018): Phase Ib/IIa – w/Etoposide/Carboplatin (02)
50 Figure 15: Opdivo for SCLC (October 12, 2018): Phase III – CheckMate 331
51 Figure 16: Tecentriq for SCLC (September 25, 2018): Phase I/III – IMpower133 (Carboplatin + Etoposide, ES-SCLC)
53 Figure 17: Key upcoming events in SCLC
56 Figure 18: Probability of success in the SCLC pipeline
57 Figure 19: Licensing and asset acquisition deals in SCLC, 2015–20
59 Figure 20: Parent patents in SCLC
61 Figure 21: Clinical trials in SCLC
61 Figure 22: Top 10 drugs for clinical trials in SCLC
62 Figure 23: Top 10 companies for clinical trials in SCLC
62 Figure 24: Trial locations in SCLC
63 Figure 25: SCLC trials status
64 Figure 26: 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: Keytruda for SCLC (January 6, 2020)
28 Table 6: HLX10 for SCLC (September 12, 2019)
29 Table 7: Onivyde for SCLC (September 8, 2019)
31 Table 8: Imfinzi for SCLC (June 27, 2019)
32 Table 9: Zepsyre for SCLC (June 1, 2019)
35 Table 10: Sacituzumab Govitecan for SCLC (April 29, 2019)
36 Table 11: Opdivo for SCLC (April 11, 2019)
38 Table 12: Keytruda for SCLC (April 1, 2019)
40 Table 13: Zepsyre for SCLC (March 25, 2019)
41 Table 14: Beleodaq for SCLC (January 17, 2019)
42 Table 15: Rova-T for SCLC (December 5, 2018)
43 Table 16: Opdivo for SCLC (November 26, 2018)
44 Table 17: Trilaciclib for SCLC (November 26, 2018)
47 Table 18: Trilaciclib for SCLC (October 21, 2018)
49 Table 19: Opdivo for SCLC (October 12, 2018)
50 Table 20: Tecentriq for SCLC (September 25, 2018)
52 Table 21: Opdivo for SCLC (August 16, 2018)
60 Table 22: Historical global sales, by drug ($m), 2014–18
60 Table 23: Forecasted global sales, by drug ($m), 2020–24
© Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed
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