Abstract #LBA292: Kohei Shitara presented primary results of the P3 SPOTLIGHT trial assessing zolbetuximab + mFOLFOX6 vs placebo + mFOLFOX6 as first-line treatment in 565 previously untreated patients with CLDN18.2+ / HER2−locally advanced unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma.

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Results:

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Thought leader reactions were positive, with many oncologists opining that the superior PFS and OS results demonstrated by zolbetuximab + mFOLFOX6 means that the combination could become standard of care in this population.

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Experts were also intrigued by how well the control group performed relative to expectations for FOLFOX6.

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Some commentators mentioned that the next step in deciding SOC for this population would be comparing zolbetuximab vs immunotherapies, with one oncologist believing that nivolumab may offer better results in some cases.

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Several oncologists noted that, with 38% of screened patients showing CLDN18.2 expression, CLDN18.2 should be added to the standard biomarker testing panel for mG/GEJ cancers.

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A few thought leaders tempered their enthusiasm for the SPOTLIGHT results based on the increased GI toxicity (16% G3/4 vomiting w/zolbetuximab).

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Summary:

‍Thought leaders believe that the PFS and OS data presented for zolbetuximab plus mFOLFOX6 are sufficient to potentially become new standard of care for CLDN18.2+HER2− mG/GEJ adenocarcinoma, though it has not been established that zolbetuximab is superior to immunotherapies and a few expressed concern about GI toxicities. Several commentators recommended adding CLDN18.2 to the standard biomarker panel for this cancer.

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