全球精准肿瘤治疗报告.pdf
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1、Supporting Precision Oncology TARGETED THERAPIES,IMMUNO-ONCOLOGY,AND PREDICTIVE BIOMARKER-BASED MEDICINESAUGUST2020Precision oncology offers to transform cancer care with medicines tailored to each patient by targeting specific bioprocesses,genetic mutations,or by precisely enhancing the individuals
2、 immune system.Precision oncology approaches started in the 1970s with the launch of tamoxifen,the first targeted therapy to interfere with specific cellular processes within a tumor.This advancement was followed by regulatory approval for immunotherapies in the 1990s that harness the immune system
3、to destroy tumor cells.Finally,precision oncology medicines became more personalized in the 2000s and beyond with the approval of predictive biomarker-based treatments,which are effective in tumors with specific molecular profiles,and cellular therapies that are genetically programed to fight cancer
4、 within individual patients.Leaps in the understanding of cancer are pushing treatments even further away from the systemic chemotherapies of the past and providing benefits to both patients and health systems.This years oncology report takes a close look at the number of novel oncology medicines la
5、unched in the United States in 2019,as well as patient access to these medicines and the use of key drug classes in precision oncology.This years report takes a look at the immuno-oncology pipeline,clinical trial activity,and shifts in clinical development to Next-Generation Therapeutics,such as the
6、 CAR T-cell therapies.The report also provides insight into the application of biomarker testing in clinical care within the United States and Europe.Clinical development of oncology therapeutics is especially complex,and the report also examines the role of biomarkers and novel trial designs within
7、 this space.The study was produced independently by the IQVIA Institute for Human Data Science as a public service,without industry or government funding.The contributions to this report of Caroline Anger,Pat Custis,Heena Darira,Jeffrey Hodge,Yasemin Karanis,Michael Kleinrock,Chris Learn,Fil Manugui
8、d,Kimberly Mehle,Elyse Muoz,Deanna Nass,Nitin Patel,Shivika Rastogi,Durgesh Soni,Dan Winkelman,and dozens of others at IQVIA are gratefully acknowledged.Find Out MoreIf you wish to receive future reports from the IQVIA Institute for Human Data Science or join our mailing list,visit iqviainstitute.or
9、g MURRAY AITKENExecutive Director IQVIA Institute for Human Data Science2020 IQVIA and its affiliates.All reproduction rights,quotations,broadcasting,publications reserved.No part of this publication may be reproduced or transmitted in any form or by any means,electronic or mechanical,including phot
10、ocopy,recording,or any information storage and retrieval system,without express written consent of IQVIA and the IQVIA Institute.IntroductionSupporting Precision Oncology:Targeted Therapies,Immuno-Oncology,and Predictive Biomarker-based MedicinesMarket trends for precision oncology therapies+The can
11、cer treatment landscape in the United States has continued to evolve since 2015 and now includes new medicines targeting 24 different cancer types.The majority are targeted therapies,drugs that block the growth of cancer by interfering with specific biological processes,and 58%require or recommend t
12、esting for pharmacogenomic biomarkers prior to use,singling out which patients are most likely to respond to a treatment based on the genomic fingerprint of their tumor.+The European Medicines Agency(EMA)approved nine new active substances(NAS)in oncology in 2019,of which five are associated with a
13、predictive biomarker and two have an approved companion diagnostic.Among these is the first approval in the region for a tissue-agnostic agent,larotrectinib,for the treatment of solid tumors with a NTRK gene fusion two years after the FDA granted its first approval of a tissue-agnostic agent,pembrol
14、izumab.+Cancer patients in the United States gain access to novel cancer therapies on average five months earlier than patients in Europe due,in part,to a stricter reimbursement environment for new cancer therapies as part of Health Technology Assessment procedures in Europe.For oncology medicines t
15、hat require pharmacogenomic testing prior to use,those that launch in the United States first reach Europe on average almost nine months later,in part,due to variable diagnostic infrastructure and limited awareness of these products by healthcare stakeholders,all of which adds additional challenges
16、for the launch of these products in the region.+Using defined daily doses(DDD)to assess changes in the use of medicines shows that checkpoint inhibitor use has grown sharply in the United States since 2014 at a compound annual growth rate(CAGR)of 111.4%and reached 2,783 DDDs per 100,000 people in De
17、cember 2019.Although European markets saw similar growth,their use was approximately half at 1,470 DDDs per 100,000 people.+In the United States,three therapies have regulatory approval for tissue-agnostic indications.Pembrolizumab(Keytruda)received the first tissue-agnostic approval for patients wi
18、th unresectable or metastatic,microsatellite instability-high(MSI-H)or mismatch repair deficient(dMMR)solid tumors in 2017,and by 2019,11%of pembrolizumab-treated patients had tumor types where treatment is informed by MSI-H/dMMR alterations,demonstrating the impact that tissue-agnostic biomarkers h
19、ave on patient uptake,despite barriers around the rarity of eligible patients and access to the necessary testing for use of tissue-agnostic therapies.Clinical applications of biomarkers +The number of clinical trials incorporating pharmacogenomic and/or pharmacogenetic analysis to stratify patients
20、 for predictive response,safety,or dosing,has more than doubled since 2010 and represents 42%of oncology trials in 2019.+In 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 tria
21、l designs supports the clinical development of precision medicines by allowing the testing of multiple agents or investigation of multiple iqviainstitute.org|1OverviewOverviewhypotheses within a single trial.They also deliver greater flexibility around the number of enrolled patients,dose selection,
22、and the ability to quickly identify and discontinue unsuccessful trials.+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
23、on continued uptake of biomarker testing.+In colorectal cancer,where the use of certain biomarker tests increased between 1319%since 2017,there has been an increase in the use of these tests in the clinical decision-making process,especially around the targeted therapies with biomarkers that predict
24、 drug response.+One universal challenge around biomarker testing has to do with the patient burden of testing.As more biomarker tests become recommended or required prior to use of therapy across cancer types,the amount of tissue available for accurate testing will further grow as an issue,paving th
25、e way for more novel methods of biomarker testing,such as the use of liquid biopsies.Pipeline for immuno-oncology and tissue-agnostic products +Immuno-oncology agents have shown significant antitumor activity across multiple tumor types.This has influenced their development and created a robust new
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