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Institute Report
Supporting Precision Oncology
Targeted therapies, immuno-oncology, and predictive biomarker-based medicines
Aug 11, 2020
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About the Report

Precision oncology offers to transform cancer care with medicines tailored to each patient by targeting specific bioprocesses, genetic mutations, or by precisely enhancing the individual’s immune system. Within this report, the current use of personalized and precision cancer medicines, associated biomarkers, the pipeline of emerging therapies and development trends are discussed, along with the range of challenges facing oncologists and other stakeholders as advances in cancer treatment shifts even further away from the systemic chemotherapies of the past. In the era of COVID-19, the FDA remains committed to expedited review for oncology products and has provided guidance to assist sponsors making clinical trial modifications due to impacts from the pandemic to ensure the safety of trial participants. Notably, as of July 7, 13 novel oncology products were approved by the agency in 2020, compared to five products in the same time frame in 2019.

Report Summary

This year’s oncology report examines market trends for targeted and predictive biomarker therapies. The number of oncology products that require or recommend biomarker testing prior to use has nearly doubled since 2015 in the United States. The report also provides insights into clinical applications of biomarkers in routine care and clinical trials. Specifically, the number of clinical trials incorporating pharmacogenomic analysis to stratify patients for predictive response, safety, or dosing, has more than doubled since 2010 and represents 42% of oncology trials in 2019. Finally, the report provides an analysis of the pipeline for immuno-oncology and tissue-agnostic products that finds over 700 immuno-oncology therapies in development from Phase I to pre-registration in 2019 along with over 20 tissue-agnostic therapies.

Key Findings


The number of predictive medicines that require or recommend biomarker testing prior to use has increased steadily in the United States and now represents nearly two-thirds of cancer therapies launched between 2015 and 2019.

U.S. New Active Substances in Oncology by Year of Indication Approval, 2015-2019

  • The cancer treatment landscape in the United States has continued to evolve since 2015, with new medicines targeting 24 different cancer types.
  • The majority of medicines were targeted therapies, and 58% require or recommend biomarker testing prior to use, to single out which patients are most likely to respond to a treatment based on the molecular fingerprint of their tumor.
  • Cancer patients in the United States gain access to novel cancer therapies on average five months earlier than patients in Europe.
  • Oncology medicines that first launch in the United States and require biomarker testing prior to use reach Europe almost nine months later, on average.

 

 

The number of clinical trials incorporating pharmacogenomic analysis to stratify patients for predictive response, safety, or dosing, has more than doubled since 2010 and represents 42% of oncology trials in 2019.

Number and Percentage of Oncology Trials by Biomarker and Immune-oncology Segmentation, 2010-2019

  • oncology, the total number of trials with innovative trial designs, which include adaptative, umbrella, and basket trials, has more than tripled since 2010.
  • The utility of novel trial designs supports the clinical development of precision medicines by allowing the testing of multiple agents or investigation of multiple hypotheses within a single trial.
  • Despite some challenges, there have been increases in the use of biomarker tests in routine care for certain tumor types across the United States and Europe.
  • The current and future use of precision oncology therapies will depend on continued uptake of biomarker testing.

 

 

In 2019, there were over 20 tissue-agnostic therapies in development across 28 unique indications.

Tissue-Agnostic Pipeline by Phase, Tumor Type, and Biomarkerm 2019

  • Immuno-oncology therapies have made up the bulk of clinical trials in oncology and the emerging oncology pipeline over the past five years.
  • The immuno-oncology new product pipeline is robust, with over 700 therapies currently in development across all phases.
  • By 2019, the early stage pipeline has started to shift away from checkpoint inhibitors and towards an increasing number of CAR products.
  • The number of CAR cell therapy trials has grown 38% since 2015, with the success of CAR T-cell therapy in B-cell cancers spurring development into other hematologic malignancies as well as solid tumors.
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