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Multicenter trial of EC145 in advanced, folate-receptor positive adenocarcinoma of the lung
Martin J Edelman1, Wael A Harb, Sridhar E Pal
1University of Maryland Greenebaum Cancer Center, Baltimore, MD, USA. medelman@umm.edu
Background:
EC145 is a novel folate-receptor targeted agent consisting of a folate molecule linked to a vinca alkaloid. EC20 is a technetium-labeled folate that assesses the presence of folate receptors (FR) in vivo. The objective of this study was to determine the activity of EC145 in patients with chemotherapy refractory lung adenocarcinoma, whose tumors expressed the FR as determined by EC20 imaging.
Methods:
Patients with advanced adenocarcinoma of the lung, Eastern Cooperative Oncology Group performance status 0 to 2, normal organ function, those who had progressed after at least two prior cytotoxic regimens, and with EC 20 uptake in at least one index lesion were eligible. The primary objective of the study was the ability to receive four or more cycles of therapy.
Results:
Sixty patients were screened and 43 patients were enrolled. Eleven patients (26%) received more than four cycles (95% confidence interval [CI] 14%, 41%), and one patient had partial response (response rate (RR) = 2.3%, 95% CI 0%, 12%). Patients in whom all target tumor lesions expressed FR by EC 20 scans had a trend toward superior results in terms of clinical benefit response (50% versus 14.3 %; p = 0.10) and survival (47.2 weeks versus 14.9 weeks [HR = 0.539, p = 0.101]) compared with those in whom at least one but not all target lesions were positive for FR (FR+).
Conclusion:
EC145 demonstrated clinical activity with a good toxicity profile in this population. Uniform uptake of EC20 may predict activity of EC145 and be useful for prospective selection of patients in future trials.
Insights
This study investigated EC145, a novel folate-receptor targeted agent, in patients with lung adenocarcinoma. EC145 showed clinical activity and a good toxicity profile, suggesting EC20 imaging may help select patients for future trials.
Area of Science:
- Oncology
- Pharmacology
- Radiopharmaceuticals
Background:
- EC145 is a novel folate-receptor targeted agent combining a folate molecule with a vinca alkaloid.
- EC20 is a technetium-labeled folate used for in vivo folate receptor (FR) imaging.
- This study evaluated EC145 activity in chemotherapy-refractory lung adenocarcinoma patients with FR-positive tumors identified by EC20.
Purpose of the Study:
- To determine the clinical activity of EC145 in patients with advanced lung adenocarcinoma.
- To assess the efficacy of EC145 in patients whose tumors express folate receptors (FR).
- To evaluate the potential of EC20 imaging for patient selection in future EC145 trials.
Main Methods:
- Patients with advanced lung adenocarcinoma, ECOG performance status 0-2, and progression after at least two prior regimens were enrolled.
- Eligibility required EC20 uptake in at least one index lesion.
- The primary objective was to assess the proportion of patients receiving four or more cycles of EC145 therapy.
Main Results:
- Of 43 enrolled patients, 26% received more than four cycles of EC145.
- A partial response was observed in one patient, yielding a response rate of 2.3%.
- Patients with uniform FR expression (all target lesions positive) showed a trend towards better clinical benefit response and survival compared to those with partial FR expression.
Conclusions:
- EC145 demonstrated clinical activity and a favorable toxicity profile in this patient population.
- Uniform EC20 uptake may predict EC145 activity.
- EC20 imaging could be valuable for prospective patient selection in future clinical trials.
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