Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration
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RESEARCH ARTICLE
Open Access
Clinical benefit of immune checkpoint inhibitors approved by US Food and Drug Administration Fei Liang1,2, Sheng Zhang1*, Qin Wang3* and Wenfeng Li4*
Abstract Background: We describe the clinical benefit of immune checkpoint inhibitors using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) and ASCO VF. Methods: We identify all approved indications of immune checkpoint inhibitors based on RCTs between January 1, 2011 and September 30, 2018 by FDA. Information including medians and HR of OS (PFS or DFS) and 95% CI, grade 3 or 4 toxicities in each arm, QOL data, survival probability at fixed time were extracted. Results: Immune checkpoint inhibitors were approved for 18 indications based on RCTs. All the indications meet the ESMO-MCBS 1.1 threshold for meaningful benefit. By the updated ASCO-VF, the median Net Health Benefit (NHB) of these agents was 55.3 (range 17.4–77.1). Two third of the indication gained the bonus points for durable survival benefits by updated ASCO VF. When updated results were incorporated in the assessment, clinical benefit of most approved immune checkpoint inhibitors increased with a median improvement of NHB of 10 (range 2–20). Conclusions: Approved immune checkpoint inhibitors provided clinical meaningful benefit by ESMO-MCBS 1.1, and most of these agents reach the threshold for bonus points for durable survival in the updated ASCO VF. Keywords: Randomized trials, Clinical benefits, Immune checkpoint inhibitors, Cancer, Food and drug administration agency
Background Knowledge of the potential benefits and risks associated with the use of anticancer therapies is fundamental for making treatment-related recommendations and decisions. Two important oncology societies have recently taken a step forward to quantize the clinical benefit. The American Society of Clinical Oncology (ASCO) Value Framework (ASCO-VF) [1], which was updated in 2016 * Correspondence: [email protected]; [email protected]; [email protected] 1 Medical Oncology, Shanghai Cancer Center, Fudan University, 270 Dongan Road, Shanghai 200032, China 3 Shanghai University of Engineering Science, Shanghai, China 4 Department of Medical oncology, the affiliated hospital of Qingdao University, Qingdao, China Full list of author information is available at the end of the article
[2], and the European Society for Medical Oncology developed its Magnitude of Clinical Benefit Scale (ESMO-MCBS) for drugs indicated in the treatment of solid cancer [3], which also updated in 2017 [4]. They have been used to grade US Food and Drug Administration (FDA)-approved new drugs for treating advanced solid cancers [5–7]. In the study by Vivot and colleagues, they found that Many recently FDA-approved new cancer drugs did not have high clinical benefit as measured by ASCO-VF and ESMO-MCBS. The growing wave of progress using cancer immunotherapy, which has extended and improved the lives of patients, many of whom had few other effective treatment options has yielded high ex
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