|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
The majority of trials of US Food and Drug Administration (FDA)-approved checkpoint inhibitor indications demonstrated a substantial benefit in the palliative setting using value frameworks established by the American Society of Clinical Oncology (ASCO) and the European Society of Medical Oncology (ESMO), according to a poster presented at the 2019 ASCO Annual Meeting.1
However, this was not true of indications in the curative setting, the research showed, indicating that refinement of the ASCO framework may be required for adjuvant trials.
According to the poster, checkpoint inhibitors are associated with significant costs and toxicities. This study was designed to apply ASCO and ESMO value frameworks to FDA-approved checkpoint inhibitors.
The researchers searched the FDA databases for checkpoint inhibitors and indications that received approval between January 2011 and January 2019. Data from randomized phase 2/3 trials for solid tumors were included. Substantial benefit was defined as an ASCO score of 45 or greater or an ESMO grade 4/5 in the palliative setting or grade A/B in the curative setting.
Of the 40 identified indications, 18 were excluded because they were based on phase 1/2 single-arm trials. The remaining 22 indications were based on 21 phase 2/3 trials.
Looking first at the palliative setting (18 trials), 73% showed substantial benefit based on ASCO frameworks (median ASCO score 54.8) and 86% based on ESMO frameworks (median ESMO score of 5). The weighted kappa was 0.719 between the 2 frameworks.
Three trials looked at checkpoint inhibitors in the curative/adjuvant setting. All 3 of these trials were assigned an ESMO grade A, but had low benefit according to ASCO framework (median 37.7).
“Ongoing development is needed into value-based frameworks in order to assist decision making for patients, physicians, and policy makers, particularly in the era of checkpoint inhibitors,” the researchers concluded.
Read more of Cancer Therapy Advisor‘s coverage of ASCO’s annual meeting by visiting the conference page.
Feng S, Cao Y, Amir E, et al. Evaluating the American Society of Clinical Oncology (ASCO) and European Society of Medical Oncology (ESMO) value frameworks for Food and Drug Administration (FDA) approved checkpoint inhibitors (CIs). Presented at: 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019. Abstract 6624.