Supporting Precision Oncology

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.

美国新的活性物质按照指示年份批准，2015-2019

• The cancer treatment landscape in the United States has continued to evolve since 2015, with new medicines targeting 24 different cancer types.
• 大多数药物是靶向疗法，58％需要或建议在使用前进行生物标志物测试，以挑出哪些患者最有可能根据其肿瘤的分子指纹反应治疗。
• 美国的癌症患者平均比欧洲患者早五个月更早获得新的癌症疗法。
• 肿瘤学药物首次在美国首次发射，需要在使用之前进行生物标志物测试，平均九个月后欧洲。

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

• 肿瘤学，自2010年以来，具有适应性，伞和篮子试验在内的创新试验设计的试验总数已超过两倍。
• 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.
• 尽管面临一些挑战，但在美国和欧洲某些肿瘤类型的常规护理中使用生物标志物测试的使用量增加了。
• 精确肿瘤疗法的当前和未来使用将取决于对生物标志物测试的持续摄取。

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

按相，肿瘤类型和生物标志物划分的组织不合时宜的管道2019

• Immuno-oncology therapies have made up the bulk of clinical trials in oncology and the emerging oncology pipeline over the past five years.
• 免疫肿瘤学新产品管道非常强大，目前在所有阶段开发了700多种疗法。
• 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.