This 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.
The research 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.
Key Topics Covered
2. KEY TAKEAWAYS
3. DISEASE BACKGROUND
- Palliative procedures
6. MARKETED DRUGS
7. PIPELINE DRUGS
8. RECENT EVENTS AND ANALYST OPINION
- Keytruda for SCLC (January 6, 2020)
- HLX10 for SCLC (September 12, 2019)
- Onivyde for SCLC (September 8, 2019)
- Imfinzi for SCLC (June 27, 2019)
- Zepsyre for SCLC (June 1, 2019)
- Sacituzumab Govitecan for SCLC (April 29, 2019)
- Opdivo for SCLC (April 11, 2019)
- Keytruda for SCLC (April 1, 2019)
- Zepsyre for SCLC (March 25, 2019)
- Beleodaq for SCLC (January 17, 2019)
- Rova-T for SCLC (December 5, 2018)
- Opdivo for SCLC (November 26, 2018)
- Trilaciclib for SCLC (November 26, 2018)
- Trilaciclib for SCLC (October 21, 2018)
- Opdivo for SCLC (October 12, 2018)
- Tecentriq for SCLC (September 25, 2018)
- Opdivo for SCLC (August 16, 2018)
9. KEY UPCOMING EVENTS
10. KEY REGULATORY EVENTS
- 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
- Tecentriq Nod For SCLC
- CHMP Recommendation For Roche's Tecentriq In Expanded Patient Population
- Merck's Keytruda Nabs First SCLC Approval
- France OKs Early Access To Tecentriq For SCLC Pending EU Approval
11. PROBABILITY OF SUCCESS
12. LICENSING AND ASSET ACQUISITION DEALS
- Jazz Acquires US Rights To PharmaMar Lung Cancer Candidate
- Luye Licenses Novel Oncology Drug From Pharmamar
13. PARENT PATENTS
14. REVENUE OPPORTUNITY
15. CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
- Prescription information
- Bristol-Myers Squibb
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