ArticleBJC reports2024
Phase 1b/2 study of the liposomal formulation of eribulin (E7389-LF) in combination with nivolumab: Results from the phase 2 esophageal cancer cohort.
Article in BJC reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04078295 (An Open-Label Phase 1b/2 Study of E7389 Liposomal Formulation Plus Nivolumab in Subjects With Solid Tumor), which is not on this map. Not yet cited in PubMed.
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An Open-Label Phase 1b/2 Study of E7389 Liposomal Formulation Plus Nivolumab in Subjects With Solid Tumor
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Authors and funding
20 authors.
Funding
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Abstract
backgroundEsophageal cancer is one of the most common types of cancer in Japan. Herein, we report the efficacy and safety of E7389-LF plus the immune checkpoint inhibitor, nivolumab, from the esophageal cancer cohort of the phase 2 part of Study 120.
methodsEligible patients received E7389-LF 2.1 mg/m
resultsOf the 35 Japanese patients enrolled, 7 (20.0%) had a partial response as their best overall response, and 14 (40.0%) had stable disease. The ORR was 20.0% (95% CI 8.4-36.9). The duration of response was 5.6 months (95% CI 1.7-not estimable [NE]). The median PFS was 2.81 months (95% CI 1.31-4.17). The median OS was not reached (95% CI 6.54 months-NE). The most common treatment-emergent adverse events were neutropenia (65.7%), pyrexia (60.0%), and leukopenia (57.1%). Select plasma endothelial cell markers levels increased from day 1 of cycle 1 and changes were pronounced between days 8-15 of each cycle.
conclusionsE7389-LF plus nivolumab showed antitumor activity in patients with unresectable and pretreated esophageal cancer and should be evaluated further in a broader population. CLINICAL
trial registrationNCT04078295.
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