Astellas Pharma’s experimental monoclonal antibody zolbetuximab has shown promising results when used as part of a combination treatment in certain gastric cancer patients, according to detailed phase 3 results recently published in The Lancet.
The late-stage SPOTLIGHT trial is evaluating first-line treatment with zolbetuximab plus mFOLFOX6 – a combination regimen that includes oxaliplatin, leucovorin and fluorouracil – in adults with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Gastric cancer is the fifth most diagnosed cancer and the fourth leading cause of cancer death worldwide, with nearly 1.1 million new cases diagnosed and more than 768,000 deaths from the disease globally in 2020. Most gastric cancers are adenocarcinomas, which develop from cells in the innermost lining of the stomach.
Because gastric cancer tends to develop slowly over many years and rarely causes early symptoms, most cases go undetected until an advanced stage.
Results from SPOTLIGHT showed that zolbetuximab treatment had a significant reduction in the risk of disease progression or death compared with placebo. The median progression-free survival was 10.61 months in the zolbetuximab group versus 8.67 months in the placebo group.
Zolbetuximab treatment also showed a significant reduction in the risk of death versus placebo.
Pranob Bhattacharya, executive director and interim head of immuno-oncology at Astellas, said: “The publication of the SPOTLIGHT study is an important report of the first phase 3 trial to demonstrate clinical benefit following CLDN18.2-targeted therapy in any tumour type, and we are honoured that it has been published in The Lancet.”
Kohei Shitara, primary investigator for SPOTLIGHT said: “Patients with HER2-negative, CLDN18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction cancers have limited first-line treatments available that are biomarker-based.
“The Lancet’s decision to publish the SPOTLIGHT study reinforces the value this data provides to the gastrointestinal cancer scientific community.”
Zolbetuximab is also being evaluated by the company with CAPOX – a combination chemotherapy regimen that includes capecitabine and oxaliplatin – in the same patient population.
Positive results from the phase 3 GLOW trial were reported last month, which showed the treatment regime reduced the risk of progression or death by 31.3% compared to placebo plus CAPOX, meeting GLOW’s primary endpoint.
The study also showed that the regime significantly prolonged overall survival, a key secondary endpoint, reducing the risk of death by 22.9%.