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ASCO 2023 | IILUSTRO: zolbetuximab, mFOLFOX6, and nivolumab combinations for gastrointestinal cancer

Kohei Shitara, MD, National Cancer Center Hospital East, Kashiwa, Japan, discusses the Phase II ILUSTRO trial (NCT03505320), which is investigating the combination of zolbetuximab, mFOLFOX6, and nivolumab in patients with advanced or metastatic claudin 18.2-positive, HER2-negative gastric or gastroesophageal junction (mG/GEJ) adenocarcinomas, with high PD-L1 expression. In previous dosing schedules from previous trials, zolbetuximab was administered fortnightly, However, zolbetuximab was administered every two weeks to fall in line with mFOLFOX6 administration in this trial which is currently ongoing. This interview took place at the American Society of Clinical Oncology (ASCO) 2023 Annual Congress in Chicago, IL.

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Transcript (edited for clarity)

This is an ongoing trial...

This is an ongoing trial. This is a March 4th, Phase II trial to investigate a kind of combination with zolbetuximab and other treatment. Now we have a two Phase III positive trials to establish chemotherapy, including FOLFOX or FOLFOXIRI with zolbetuximab for claudin positive population. So next two steps should be how we can improve the outcome. Also, another critical question is which treatment, chemotherapy/zolbetuximab or chemotherapy plus checkpoint inhibitors should be used for specific subgroup with high PD-L1 and high claudin. So to answer this kind of question, we try to evaluate the combination with FOLFOX and nivolumab and zolbetuximab. And another interesting aspect is the dosing schedule observed in the pivotal Phase II trial. We applied every three weeks administration of zolbetuximab an observed because this was established dosing schedule during previous Phase I and Phase II (trials). But there is some asynchronous administration because FOLFOX is usually given every two weeks and zolbetuximab maybe three weeks. So a little bit inconvenient for us and our patient. So that’s why in this study we try to combine every two weeks administration with zolbetuximab with initial dose observed detection is same between two weeks and three weeks, but we try to use reduced dose 400 milligram for every two weeks and the study is now ongoing to test the feasibility and evaluate the efficacy in expansion population.