Mesothelioma is an aggressive and rare form of cancer which develops in the lining of the heart, lungs, or abdomen. Exposure to asbestos is the primary cause of the disease. The inhalation or swallowing of asbestos leads to an accumulation in the lining of the lungs or the abdomen, causing damage to the tissue. This, in turn, leads to damage to the cells' DNA, and uncontrolled cell growth.
Datamonitor Healthcare estimates that in 2017, there were 18,900 incident cases of mesothelioma in adults aged 45 years and older worldwide, and forecasts that number to increase to 22,690 incident cases by 2026. Oceania is estimated to have the highest disease incidence (2.85 per 100,000 males, and 0.50 per 100,000 females), while Latin America and the Caribbean has the lowest incidence (0.29 per 100,000 males, and 0.17 per 100,000 females).
The approved drugs in the mesothelioma space target thymidylate synthase, the immune system, programmed death-1 receptor/programmed death ligands, and dihydrofolate reductase. All of the approved drugs are administered via the intravenous route.
The majority of industry-sponsored drugs in active clinical development for mesothelioma are in Phase II. Therapies in the mesothelioma space focus on a wide variety of targets. The majority of drugs in development for mesothelioma are administered via the intravenous route, with the remainder being intramuscular, oral, intratumoral, percutaneous catheter/injection, and subcutaneous formulations.
The only high-impact upcoming event for drugs in the mesothelioma space is topline Phase II trial results for Zepsyre. The overall likelihood of approval of a Phase I mesothelioma asset is 6.3%, and the average probability a drug advances from Phase III is 33.3%. Drugs, on average, take 14.8 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
There have been seven licensing and asset acquisition deals involving mesothelioma drugs during 2014-19. The $475m licensing agreement signed in 2017 between Calithera Biosciences and Incyte to research, develop, and commercialize Calithera's CB-1158 was the largest deal.
The distribution of clinical trials across Phase I-IV indicates that the vast majority of trials have been in the early and mid-phases of development, with 95% of trials in Phase I-II, and only 5% in Phase III-IV.
The US has a substantial lead in the number of mesothelioma clinical trials globally. The UK leads the major EU markets, while Japan has the top spot in Asia.
Clinical trial activity in the mesothelioma space is dominated by completed trials. Eli Lilly has the highest number of completed clinical trials for mesothelioma, with 44 trials. Eli Lilly also leads industry sponsors with the highest overall number of clinical trials for mesothelioma.
TABLE OF CONTENTS
RECENT EVENTS AND ANALYST OPINION
- Optune for Mesothelioma (April 02, 2019)
- SEL-403 for Mesothelioma (October 17, 2018)
- Tazemetostat for Mesothelioma (September 24, 2018)
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
- US FDA Greenlights First-In-Kind Diagnostics, Device
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
LIST OF FIGURES
- Figure 1: Trends in incident cases of mesothelioma, 2017-26
- Figure 2: Overview of pipeline drugs for mesothelioma in the US
- Figure 3: Pipeline drugs for mesothelioma, by company
- Figure 4: Pipeline drugs for mesothelioma, by drug type
- Figure 5: Pipeline drugs for mesothelioma, by classification
- Figure 6: Key upcoming events in mesothelioma
- Figure 7: Probability of success in the mesothelioma pipeline
- Figure 8: Licensing and asset acquisition deals in mesothelioma, 2015-20
- Figure 9: Parent patents in mesothelioma
- Figure 10: Clinical trials in mesothelioma
- Figure 11: Top 10 drugs for clinical trials in mesothelioma
- Figure 12: Top 10 companies for clinical trials in mesothelioma
- Figure 13: Trial locations in mesothelioma
- Figure 14: Mesothelioma trials status
- Figure 15: Mesothelioma trials sponsors, by phase
LIST OF TABLES
- Table 1: Incident cases of mesothelioma, 2017-26
- Table 2: Incidence rates of mesothelioma, 2017-26
- Table 3: Marketed drugs for mesothelioma
- Table 4: Pipeline drugs for mesothelioma in the US
- Table 5: Optune for Mesothelioma (April 02, 2019)
- Table 6: SEL-403 for Mesothelioma (October 17, 2018)
- Table 7: Tazemetostat for Mesothelioma (September 24, 2018)
- Table 8: Historical global sales, by drug ($m), 2014-18
- Table 9: Forecasted global sales, by drug ($m), 2020-24