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Institute Report
Evolving Oncology Endpoints
A new horizon for health outcomes
Jul 08, 2021
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About the Report

This report examines trends in new and evolving oncology endpoints being studied in clinical trials. It also looks closely at how these evolving endpoints could potentially be used to evaluate clinical benefit, support regulatory approval, and inform payer reimbursement decisions effectively and more efficiently. Case examples are included to paint a picture of how payers in the EU and U.S. are beginning to evaluate these evolving clinical trial endpoints as part of reimbursement decisions.

Report Summary

Advances in cancer treatments have led to longer survival for patients across a range of tumor types. Traditionally, clinical trials for medicines measure long-term survival and do not measure evolving endpoints, but this presents a challenge because of the need to get the right product to patients at the right time. This has prompted the exploration of new, evolving endpoints that consider the difficulty in capturing long-term survival, while still providing a means to measure clinical value for adjuvant and neoadjuvant therapies and allowing for the comparison of trials across multiple dimensions. Although these evolving endpoints have already been used for regulatory approvals, there are still conflicting opinions among payers on when they may inform reimbursement decisions. Assessing the landscape of emerging endpoints provides all stakeholders with visibility to the issues that require further consideration and investigation as they move closer to broad use for regulatory approvals and reimbursement – and ensure that timely access to novel therapies can be provided to patients with cancer who need them.

Key Findings

Exhibit 2: Advantages and Disadvantages of Endpoints
  • PFS is frequently used as a surrogate marker for regular and accelerated/conditional approval, which requires limited patient numbers and shorter follow-up periods relative to OS. 
  • ORR can also be used as a surrogate marker, allowing for clinical benefits to be measured in a shorter period of time compared to survival. 
  • Additionally, the strength of association between ORR or CR and either PFS or OS vary widely between and within studies, making it difficult to discern a consistent pattern.
Exhibit 3: Summary of Total Primary Endpoints
  • Evolving endpoints make up 13% of primary endpoints used in Phase II or III trials.
  • The evolving endpoints most commonly used in clinical trials are pathologic complete response followed by relapse rate and disease-free survival.
Exhibit 6: Occurrence of Endpoints in Clinical Trials Annually (2016-2020)
  • The use of disease control rate has been increasing over the last five years within clinical trials.
  • Both minimal residual disease and relapse rate have the greatest increase in use over the last year.
Exhibit 9: Summary of Qualitative Discussions for Evolving Endpoints in Priority Indications
  • Based on qualitative discussions, emerging endpoints were identified as more relevant for adjuvant or neoadjuvant patients – including DFS, MRD, pCR, RR, and time to response.
  • Across the board, emerging endpoints are relevant for newer products with improved efficacy and long-term survival, but some endpoints (e.g., time to response) may not be applicable for HTA evaluations.
  • Emerging endpoints were less relevant for advanced or metastatic tumors, but disease control rates could have relevance to measure progression of metastatic disease not treated with a curative intent.
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