About Locally Advanced Unresectable Metastatic Gastric Cancer and Gastroesophageal Junction Cancer (GEJ)

Gastric cancer is the fifth most diagnosed cancer worldwide.

Signs and symptoms can include indigestion or heartburn; pain or discomfort in the abdomen; nausea and vomiting; diarrhea or constipation; bloating of the stomach after meals; and loss of appetite and sensation of food getting stuck in the throat while eating.

Signs of more advanced gastric cancer can include unexplained weight loss; weakness and fatigue; and vomiting blood or having blood in the stool.

Risk factors associated with gastric cancer can include older age, male gender, family history, H. pylori infection, smoking and gastroesophageal reflux disease (GERD).

Because early-stage gastric cancer symptoms frequently overlap with more common stomach-related conditions, the disease is often diagnosed in the advanced or metastatic stage, or once it has spread from the tumor’s origin to other body tissues or organs.

Gastric and GEJ cancers still have very limited treatment options available for patients with an advanced diagnosis.

About the Spotlight Study

Spotlight is a global, multicenter, double-blind, randomized study that is investigating the efficacy and safety of zolbetuximab.

Approximately 566 patients have been enrolled in the study.

In arm A, patients received combination with zolbetuximab and mFOLFOX6.

After mFOLFOX6 is complete, patients are permitted to receive fluorouracil (5-FU) and folinic acid until the patient meets the study treatment discontinuation criteria.

Patients in arm B are administered matching placebo and mFOLFOX6 and may also receive 5-FU and folinic acid after mFOLFOX6 completion.

The study is ongoing at 220 locations worldwide.

It is expected to be completed in January 2025.

In addition to Spotlight, zolbetuximab is also being investigated in combination with capecitabine and oxaliplatin (CAPOX) vs placebo and CAPOX in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric adenocarcinoma (GLOW; NCT03653507).

Spotlight Results in Gastric Cancer and Gastroesophageal Junction Cancer

Initial results from the phase 3 spotlight study show that the study met its primary and key secondary end point of the duration of the period patients did not progress (also called “Progression-Free Survival, PFS) and Survival.

Treatment with zolbetuximab plus chemotherapy led to statistically significant progression-free survival (PFS) improvement in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

These topline results further support the role of CLDN18.2 as an emerging biomarker in gastric and GEJ cancer.

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