Scottish Medicines Consortium the first in the UK to adopt the precision medicine VYLOY™ ▼ (zolbetuximab) for the treatment of advanced gastric and gastro-oesophageal cancer

Astellas Pharma Ltd. has announced this week that the Scottish Medicines Consortium has accepted VYLOY™ ▼ (zolbetuximab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive.⁴ It is estimated that 38 per cent of patients with locally advanced unresectable or metastatic gastric and GEJ adenocarcinomas will be CLDN 18.2 positive.^6,7

It is estimated that 386 patients per year in Scotland have advanced or metastatic gastric cancer that cannot be removed with surgery or has spread to other parts of the body.⁵ There is a high unmet need for treatment options that slow progression and prolong life.

Zolbetuximab is the first innovative precision medicine designed to attach to CLDN18.2, a protein involved in keeping the cells of the stomach lining tightly attached to each other.⁶ When these cells become cancerous, the CLDN18.2 proteins may become exposed, allowing zolbetuximab to attach to the cancer cells. The immune system is then able to attack and kill the cancer cells, slowing down the progress of the disease.^7,8

Professor Russell Petty, Professor Medical Oncology, Director of Tayside Medical Science Center (TASC) School of Medicine, University of Dundee, said: “The SMC recommendation of zolbetuximab reflects our ambition as doctors to deliver cutting-edge care for cancer patients in NHS Scotland through precision medicine. By moving beyond one-size-fits-all methods and targeting specific features of a tumour, like CLDN18.2, it’s possible to deliver more effective therapies, ultimately extending a patients’ time with their loved ones.”

Dr Timir Patel (pictured), Astellas Medical Director, said: “Zolbetuximab is an innovative approach to treating advanced gastric cancer. Today’s recommendation by the SMC highlights the importance of personalised approaches in cancer care and underscores the potential of zolbetuximab to improve patient outcomes.

“Astellas is dedicated to advancing our understanding of cancer biology to develop treatments for the most challenging cancers. We strive to provide doctors with essential options and patients with more time with their loved ones. This decision shows our commitment to helping patients access treatments in the areas of greatest unmet clinical need.”

The decision is based on the results from the Phase 3 SPOTLIGHT and GLOW trials, which, between the two multi-centre, double-blind, randomised studies, recruited 1,072 patients. In the SPOTLIGHT trial, a median progression free survival (PFS) of 10.61 months was achieved with zolbetuximab plus mFOLFOX6 as first-line treatment, versus 8.67 months with placebo plus mFOLFOX6. The median OS was 18.23 months versus 15.54 months in the respective treatment groups. Similar efficacy findings were seen in the GLOW trial where median PFS was 8.21 months versus 6.80 months, and median OS 14.39 months versus 12.16 months, with zolbetuximab plus CAPOX, compared to placebo plus CAPOX, respectively. In both the SPOTLIGHT and GLOW trials, the incidence of serious treatment emergent adverse events (TEAEs) was similar in the zolbetuximab treatment groups compared to the controls. The most common all-grade TEAEs reported in the zolbetuximab treatment groups were nausea, vomiting and decreased appetite.^6,7

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