P-30 Ramucirumab beyond progression plus TAS-102 in patients with advanced or metastatic esophagogastric adenocarcinoma, after treatment failure on a ramucirumab-based therapy – final results of the phase II RE-ExPEL study

Based on results of prior trials (TAGS, REGARD, RAINBOW), it seems promising to combine Ramucirumab (Ram) beyond progression (PD) with TAS-102 (trifluridine/tipiracil). The purpose RE-ExPEL is investigate the tolerability, safety and benefit Ram PD in combination advanced esophagogastric adenocarcinoma (EGA). This a multicenter, non-randomized, open-label investigator initiated pilot trial. 20 ram-pretreated patients (pts) EGA were enrolled maximum 4 cycles ramucirumab 8mg/kg every two weeks (days 1, 15; qd28) plus 35 mg/m2 /p.o. bid (d1-5 d8-12; qd28). Primary endpoint (EP) was tolerability toxicity, defining positive trial if SAE rate according (acc.) CTCAE 5.0 will increase less than 30% (up 55%) compared from TAGS (SAE-rate 43%). Secondary EPs are further data efficacy data, OS, PFS ORR. pts (20% female) between Oct 2020 Aug 2021, 20% gastric 80% GEJ- cancers, 55% ECOG 0. Results final analysis showed that only 25% had at least one total no. SAEs 9, fatal outcome, all without relationship systemic therapy no SUSAR reported. able show median OS 9.1 mo (95% CI 5.4;10.1), 2.9 (1.7;4.8) DCR 45%. 90% got study medication 3rd line whereas 10% even pts. favorable profile low severe toxicity for ram+TAS-102, maybe due long disease stabilization therefore tumor associated symptoms. Regarding primary endpoint, numerically lower TAGS. Furthermore, very ram mo. Ram+TAS-102 be more effective alone acc. TAGS-trial respecting limitation arm design 20pts. needs evaluation randomized phase III