Abstract 88P
Background
The WHO Model List of Essential Medicines (EML) serves as guidance for the development of national lists of essential medicines. Since ipilimumab was first approved in 2011, immune checkpoint inhibitors (ICI) have changed the oncologic treatment landscape, leading to significant survival advantages. However, except for malignant melanoma, repeated EML applications of ICIs were unsuccessful and global access remains limited. This study was part of a WHO EML application for the therapeutic class of ICIs in the palliative first-line treatment setting of adult cancers and aims to provide a prioritization framework to select ICIs and indications with the highest potential for EML inclusion.
Methods
After drafting a goal-directed, sequential prioritization plan, the European Medicines Agency’s (EMA) drug database was searched systematically for approved ICI and treatment indications. Next, based on the potential population reach and availability of high-level evidence, ICI-containing treatments approved for the palliative first-line setting were reviewed. Lastly, ESMO-Magnitude of Clinical Benefit Scale (MCBS) scorecards were examined to identify therapeutic indications with a score of 4 or 5, denoting a substantial clinical benefit. ESMO experts will review top-ranked regimens and cancers to complement the evidence about efficacy and harms, judge feasibility and accessibility, and discuss controversial additions.
Results
The EMA drug database search yielded 11 ICIs with 76 different approvals for 21 cancer types and subtypes. Of these, 44 approvals were in the palliative first-line setting. Evaluation against ESMO-MCBS scorecards led to the inclusion of 29 approvals for further evaluation and analysis. Briefing documents for selected cancers and ICIs, with input from ESMO experts, will enhance the transparency and completeness of the EML application to support the WHO Expert committee's selection.
Conclusions
Our research demonstrates the feasibility of using the ESMO-MCBS as part of a framework to identify and prioritise promising ICI-containing treatment regimens for WHO EML application. Therefore, further exploration of the framework as part of the WHO EML application process is warranted.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
89P - Safety and efficacy of rechallenge with immune checkpoint inhibitors in advanced solid tumor: A systematic review and meta-analysis
Presenter: Huijun Xu
Session: Poster Display session
Resources:
Abstract
90P - Meta-analysis of hypophysitis incidence in melanoma patients treated with immune checkpoint inhibitors
Presenter: Vincas Urbonas
Session: Poster Display session
Resources:
Abstract
91P - Territorial disparities in the use of hospitalization at home for immune checkpoint inhibitors infusion in France between 2021 and 2022
Presenter: Anne Claire Toffart
Session: Poster Display session
Resources:
Abstract
92P - An investigation on the differences between the pre-treatment nutritional and immunological status of nasopharyngeal carcinoma patients and the healthy population
Presenter: Qiao He
Session: Poster Display session
Resources:
Abstract
93P - Pseudoprogression in immunotherapy: Illusion or reality? P-PIT study
Presenter: Amelie Toulet
Session: Poster Display session
Resources:
Abstract
94P - Real-world characteristics, treatments and healthcare recourse utilization (HCRU) of patients (pts) with advanced/metastatic non-small cell lung cancer (mNSCLC) managed with first line (1L) immuno-oncology (IO) strategies in Greece: The IO-HORIZON study
Presenter: Dimitrios Ziogas
Session: Poster Display session
Resources:
Abstract
95P - Quality of life (QoL) and care pathway in patients with durable response to immune checkpoint inhibitors (ICI-DR) for advanced or metastatic non-small cell lung cancer (NSCLC) or melanoma: QUALICI study
Presenter: Nicolas Girard
Session: Poster Display session
Resources:
Abstract
96P - Comparative cardiovascular risks of PD-1 vs. PD-L1 inhibitors: A meta-analysis of incidence and severity of cardiotoxicity
Presenter: Mohammedbaqer Al-Ghuraibawi
Session: Poster Display session
Resources:
Abstract
97P - Cardiac risk stratification and serial monitoring during immune checkpoint inhibitor therapy: Prospective real-world experience
Presenter: James Knott
Session: Poster Display session
Resources:
Abstract
98P - Immuno-related cardiac toxicity: a prospective study applying multiparametric cardiac MRI
Presenter: Agnese Losurdo
Session: Poster Display session
Resources:
Abstract