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Market Spotlight: Small-Cell Lung Cancer (SCLC)

  • Report

  • 49 Pages
  • November 2020
  • Region: Global
  • Citeline
  • ID: 4421372
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

The publisher 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 III trial results for Zepzelca and Imfinzi, and an estimated PDUFA date for trilaciclib.

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 42.9%. Drugs, on average, take 9.6 years from Phase I to approval, compared to 9.5 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.

Table of Contents

OVERVIEWKEY TAKEAWAYSDISEASE BACKGROUND
TREATMENT
  • Chemotherapy
  • Radiotherapy
  • Immunotherapy
  • Surgery
  • Palliative procedures

EPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGS
RECENT EVENTS AND ANALYST OPINION
  • Unituxin for SCLC (February 3, 2020)
  • Keytruda for SCLC (January 6, 2020)
  • HLX10 for SCLC (September 12, 2019)
  • Onivyde for SCLC (September 8, 2019)
  • Imfinzi for SCLC (June 27, 2019)
  • Zepzelca for SCLC (June 1, 2019)

KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
  • US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal
  • Imfinzi Among Myriad Hopefuls Seeking Extended Indications In EU
  • Zepzelca Speeds To Accelerated Approval For SCLC
  • NICE Rejects Tecentriq For SCLC In England
  • Roche’s Tecentriq Gets Another Indication In India But Pricing Hurts
  • AstraZeneca Gets Fast Imfinzi Review For SCLC

PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
  • Gilead Buys Pipeline-In-A-Product With $21bn Immunomedics Deal
  • Simcere Acquires China-Plus Rights To G1’s Trilaciclib
  • SciClone Gains China-Plus Rights To EpicentRx’s Novel Cancer Candidate
  • G1 Believes Boehringer Is Better Bet To Sell Trilaciclib
  • Jazz Acquires US Rights To PharmaMar Lung Cancer Candidate

REVENUE OPPORTUNITY
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events

BIBLIOGRAPHY
  • Prescription information

APPENDIX
List of Figures
  • Figure 1: Trends in incident cases of SCLC, 2019-28
  • Figure 2: Overview of pipeline drugs for SCLC in the US
  • Figure 3: Pipeline drugs for SCLC, by company
  • Figure 4: Pipeline drugs for SCLC, by drug type
  • Figure 5: Pipeline drugs for SCLC, by classification
  • Figure 6: Unituxin for SCLC (February 3, 2020): Phase II/III - DISTINCT
  • Figure 7: Keytruda for SCLC (January 6, 2020): Phase III - KEYNOTE-604 (ES-SCLC)
  • Figure 8: Onivyde for SCLC (September 8, 2019): Phase II/III - RESILIENT
  • Figure 9: Imfinzi for SCLC (June 27, 2019): Phase III - CASPIAN
  • Figure 10: Zepzelca for SCLC (June 1, 2019): Phase II - Solid Tumors (Relapsed SCLC; EU/US)
  • Figure 11: Key upcoming events in SCLC
  • Figure 12: Probability of success in the solid tumors pipeline
  • Figure 13: Clinical trials in SCLC
  • Figure 14: Top 10 drugs for clinical trials in SCLC
  • Figure 15: Top 10 companies for clinical trials in SCLC
  • Figure 16: Trial locations in SCLC
  • Figure 17: SCLC trials status
  • Figure 18: SCLC trial sponsors, by phase

List of Tables
  • Table 1: Incident cases of SCLC, 2019-28
  • Table 2: Incidence rates of SCLC
  • Table 3: Marketed drugs for SCLC
  • Table 4: Pipeline drugs for SCLC in the US
  • Table 5: Unituxin for SCLC (February 3, 2020)
  • Table 6: Keytruda for SCLC (January 6, 2020)
  • Table 7: HLX10 for SCLC (September 12, 2019)
  • Table 8: Onivyde for SCLC (September 8, 2019)
  • Table 9: Imfinzi for SCLC (June 27, 2019)
  • Table 10: Zepzelca for SCLC (June 1, 2019)
  • Table 11: Historical global sales, by drug ($m), 2015-19
  • Table 12: Forecasted global sales, by drug ($m), 2020-24

Companies Mentioned

  • Bristol-Myers Squibb
  • CytRx
  • GlaxoSmithKline
  • NantCell
  • Pfizer