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).
- Celgene’s amrubicin, Novartis’s Hycamtin, Merck & Co’s Keytruda, Aeterna’s lobaplatin, Bristol-Myers Squibb’s Opdivo, and Roche’s Tecentriq are the only marketed drugs for SCLC. 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 mid-to-late-stage development for SCLC focus on a wide variety of targets. The majority of the drugs in mid-to-latestage 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, Phase II/III, and Phase III trial results, and an expected supplemental CHMP opinion.
- The overall likelihood of approval of a Phase I solid tumor asset is 5.8%, and the average probability a drug advances from Phase III is 40.3%. 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 12 licensing and asset acquisition activities involving SCLC drugs during 2014–19. The license agreement made in 2017 between CytRx and NantCell for the exclusive rights to develop and market aldoxorubicin for $356m was the largest deal.
- 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 40 trials, respectively.
- Pfizer and GlaxoSmithKline lead industry sponsors with the highest overall number of clinical trials for SCLC
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
27 RECENT EVENTS AND ANALYST OPINION
27 Imfinzi for SCLC (June 27, 2019)
28 Zepsyre for SCLC (June 1, 2019)
30 Sacituzumab Govitecan for SCLC (April 29, 2019)
31 Opdivo for SCLC (April 11, 2019)
33 Keytruda for SCLC (April 1, 2019)
35 Zepsyre for SCLC (March 25, 2019)
36 Beleodaq for SCLC (January 17, 2019)
37 Rova-T for SCLC (December 5, 2018)
38 Opdivo for SCLC (November 26, 2018)
40 Trilaciclib for SCLC (November 26, 2018)
42 Trilaciclib for SCLC (October 21, 2018)
44 Opdivo for SCLC (October 12, 2018)
46 Tecentriq for SCLC (September 25, 2018)
47 Opdivo for SCLC (August 16, 2018)
49 KEY UPCOMING EVENTS
50 KEY REGULATORY EVENTS
50 Merck’s Keytruda Nabs First SCLC Approval
50 France OKs Early Access To Tecentriq For SCLC Pending EU Approval
50 Tecentriq’s SCLC Success Takes Edge Off Roche’s IO Position
50 Bristol’s Opdivo Enjoys IO First-Mover Advantage In SCLC
51 PROBABILITY OF SUCCESS
52 LICENSING AND ASSET ACQUISITION DEALS
52 Luye Licenses Novel Oncology Drug From Pharmamar
53 PARENT PATENTS
54 REVENUE OPPORTUNITY
55 CLINICAL TRIAL LANDSCAPE
56 Sponsors by status
57 Sponsors by phase
58 Recent events
59 BIBLIOGRAPHY
59 Prescription information
60 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: Imfinzi for SCLC (June 27, 2019): Phase III – CASPIAN
30 Figure 7: Zepsyre for SCLC (June 1, 2019): Phase II – Solid Tumors (Relapsed SCLC; EU/US)
33 Figure 8: Opdivo for SCLC (April 11, 2019): Phase III – CheckMate-451 (Maintenance)
35 Figure 9: Keytruda for SCLC (April 1, 2019): Phase Ib – KEYNOTE-028 (PD-L1 Positive Tumors), Phase II – KEYNOTE-158
40 Figure 10: Opdivo for SCLC (November 26, 2018): Phase III – CheckMate-451 (Maintenance)
42 Figure 11: Trilaciclib for SCLC (November 26, 2018): Phase II – w/Tecentriq+Chemotherapy
44 Figure 12: Trilaciclib for SCLC (October 21, 2018): Phase Ib/IIa – w/Etoposide/Carboplatin (02)
46 Figure 13: Opdivo for SCLC (October 12, 2018): Phase III – CheckMate 331
47 Figure 14: Tecentriq for SCLC (September 25, 2018): Phase III – IMpower133 (Carboplatin + Etoposide, ES-SCLC)
49 Figure 15: Key upcoming events in SCLC
51 Figure 16: Probability of success in the SCLC pipeline
52 Figure 17: Licensing and asset acquisition deals in SCLC, 2014–19
53 Figure 18: Parent patents in SCLC
55 Figure 19: Clinical trials in SCLC
55 Figure 20: Top 10 drugs for clinical trials in SCLC
56 Figure 21: Top 10 companies for clinical trials in SCLC
56 Figure 22: Trial locations in SCLC
57 Figure 23: SCLC trials status
58 Figure 24: 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
27 Table 5: Imfinzi for SCLC (June 27, 2019)
29 Table 6: Zepsyre for SCLC (June 1, 2019)
31 Table 7: Sacituzumab Govitecan for SCLC (April 29, 2019)
32 Table 8: Opdivo for SCLC (April 11, 2019)
34 Table 9: Keytruda for SCLC (April 1, 2019)
36 Table 10: Zepsyre for SCLC (March 25, 2019)
37 Table 11: Beleodaq for SCLC (January 17, 2019)
38 Table 12: Rova-T for SCLC (December 5, 2018)
39 Table 13: Opdivo for SCLC (November 26, 2018)
40 Table 14: Trilaciclib for SCLC (November 26, 2018)
43 Table 15: Trilaciclib for SCLC (October 21, 2018)
45 Table 16: Opdivo for SCLC (October 12, 2018)
46 Table 17: Tecentriq for SCLC (September 25, 2018)
48 Table 18: Opdivo for SCLC (August 16, 2018)
54 Table 19: Historical global sales, by drug ($m), 2014–18
54 Table 20: Forecasted global sales, by drug ($m), 2019–23
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