The following is an excerpt from the eBook Checkpoint Inhibitors: Takeaways and Best Practices for Strategic Planning
It’s very clear that the race to finding the next best immune checkpoint inhibitor (or stimulator) is on. A staggering number of trials have been initiated evaluating agents as monotherapies or in combination with the favored PD-1/PD-L1 therapies that have reformed the oncology landscape.
While the number of agents is ever increasing, so too is the challenge pharmaceutical companies will face attempting to bring these agents to market. Physicians are becoming increasingly skeptical of emerging agents following high profile late phase trial failures.
While the largest market share will undoubtedly be claimed by the best clinical profiles and the earliest agents to market, biopharma companies will more likely receive approval for agents who have demonstrated efficacy in well-designed trials, with relevant comparators, large patient numbers and scientifically proven mechanisms of action.
Here we outline 9 key takeaways for planning in this volatile market:
Treatment paradigm will continue to change: The vast array of novel immune checkpoint agents currently in development have the potential to dramatically alter the treatment paradigm of many malignancies.
High costs will impact uptake and reimbursement: Immune checkpoint inhibitors are premium priced agents from which pharmaceutical companies can benefit financially.
Drug cost however, will be a huge determinant on drug uptake and reimbursement, particularly for therapies where two or more premium priced agents are used in combination.
Monotherapies could falter: Novel immune checkpoint inhibitors which are being positioned as monotherapies may struggle against the growing tide of combinations of currently approved immune checkpoint inhibitors.
Gaining approval may become more difficult: As the number of agents under development in this field increase, rapidly shifting best practices and changing standards of care will mean attaining regulatory approval will become increasingly difficult.
Trial design will be crucial: Robust data from Phase II trials, supported in a larger Phase III trial will be necessary to ensure regulatory approval and physician support, particularly in indications where alternative treatments are already available. High profile Phase III fails despite promising phase II data will limit the number of agents receiving accelerated approvals from Phase II trials.
Need to prove OS improvements: Although historically PFS has been accepted as a surrogate endpoint for some trials, novel agents will likely have to prove OS improvements to really drive significant physician uptake.
Comparator choices are key: Correct comparator choices within these trials will ensure payer acceptance and reimbursement. Data comparing the novel agent directly to the current standard of care will be crucial in countries with national health care systems such as the United Kingdom.
Clear sub populations can boost uptake: Identifying a clear niche or sub population within the market will maximize the uptake of novel agents. Companion diagnostics and biomarkers which will delineate treatment decisions will boost novel agents use.
Combination strategy can help break through: Combination therapy, either with established agents or the standard of care for specific indications may facilitate entry into a crowded market. When differences in efficacy and safety are negligible, physician familiarity with a combination therapy may help increase uptake.
Want more takeaways to help planning?
Read the full eBook for an analysis of the checkpoint inhibitor landscape:
- Emerging agents and key clinical trials
- Disease management and access considerations
- Oncologist KOL perspectives
- Key takeaways for biopharma strategists