Novel Drug-Chemo Combination Improves Outcomes for Advanced Gastric Cancers

Adding the novel drug zolbetuximab to the chemotherapy regimen known as mFOLFOX6 (oxaliplatin, leucovorin and fluorouracil) improved outcomes for patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, according to findings from a phase 3 trial.

Astellas, the manufacturer of zolbetuximab, announced positive results from the SPOTLIGHT trial, which is a global phase 3 clinical trial including 566 patients who were randomly assigned to receive either zolbetuximab plus mFOLFOX6 or placebo plus mFOLFOX6, according to a press release.

The trial met its main goal, which was improved progression-free survival (time from treatment until disease worsens) for patients given zolbetuximab plus mFOLFOX6 compared to those given placebo plus mFOLFOX6. Additionally, the trial met its secondary goal, with the zolbetuximab-containing regimen leading to improved average overall survival (time from treatment until death from any cause).

"I am excited by the potential for a new treatment option to help patients with advanced-stage gastric cancer or GEJ cancer," said Dr. Kohei Shitara, primary investigator for the SPOTLIGHT trial and chief of the department of gastrointestinal oncology at the National Cancer Center Hospital East in Kashiwa, Japan, in a company-issued press release. "Gastric and GEJ cancers still have very limited treatment options available for patients with an advanced diagnosis."

Zolbetuximab works by binding to CLDN18.2, a protein found on the cell surface of gastric epithelial cells, according to the release. Once the drug is latched on to the cancer cells, it activates immune system pathways that kill the cells, according to preclinical studies.

"These topline results further support the role of CLDN18.2 as an emerging biomarker in gastric and GEJ cancer.” said Dr. Ahsan Arozullah, senior vice president and head of development therapeutic areas at Astellas, in the release.

The most common treatment-related side effects were nausea, vomiting and decreased appetite.

More detailed findings will be presented at a future medical meeting, according to the release.

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