Barriers to clinical implementation for novel therapies and biomarker testing in the community practice oncology setting: A CLDN18.2 case study

PurposeCommunity-based practices often experience extended adoption times when implementing novel targeted agents, due to practical barriers. Delayed implementation of new therapies can potentially increase patient burden. This study aimed to objectively identify and quantify practice challenges to the implementation of new therapies in the community setting.MethodsIn this pilot study, challenges associated with zolbetuximab, a potential first-in-class claudin 18.2 (CLDN18.2) monoclonal antibody and companion diagnostic, was assessed. Between April and August 2024, 53 data-collection events were held representing 32 states across the US. Data from 483 oncologists were recorded and analyzed.ResultsCommunity oncologists were split regarding their familiarity with CLDN18.2 as a therapeutic target in gastric/gastroesophageal junction (G/GEJ) cancer. Awareness of zolbetuximab data was low among community oncologists with most community oncologist having not seen the results from the phase 3 studies. However, oncologists anticipate zolbetuximab will impact their treatment of CLDN18.2+ patients with metastatic (m)G/GEJ cancer. Community oncologists reported access to CLDN18.2 testing is a challenge to the adoption of zolbetuximab. Most community oncologists would recommend zolbetuximab + chemotherapy for a HER2-, CLDN18.2+ patient with a combined positive score (CPS) of 2; however, if the patient had a CPS of 10, most would recommend chemotherapy + immunotherapy.ConclusionsFirst-in-class targeted agents encounter additional practical challenges when being implemented in the community practice setting. Education on patient identification and proper utilization could result in improved patient outcomes due to timelier implementation of targeted agents. Data-sharing and collection-platforms could be an instrumental tool in the assessment of practical challenges associated with the implementation of first-in-class agents in the community oncology setting.Implications for practiceIdentifying practice barriers and proactively addressing them can result in a more rapid adoption of new therapies. This study identified 4 major challenges to the adoption of the novel targeted agent, zolbetuximab, in the community practice setting: limited awareness of clinical trial data, inadequate biomarker testing infrastructure, uncertainty in identifying optimal patient populations, and access barriers related to cost and insurance coverage. By implementing strategies identified from this study, we hope to accelerate and improve future adoption to innovative treatments in the community oncology setting, ultimately improving patient outcomes.