NMPA approves Vyloy + chemo for HER2- gastric cancer
Astellas Pharma In, announced that China's National Medical Products Administration (NMPA) has approved in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HEVyloy (zolbetuximab), R2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive
Zolbetuximab is the first NMPA-approved monoclonal antibody to target gastric tumor cells that express the biomarker CLDN18.2, offering a highly targeted approach to cancer treatment.
Gastric cancer is the third leading cause of cancer-related mortality in China, with more than 260,000 deaths reported from the disease in 2022. As early symptoms are often hard to detect, approximately 60% of Chinese patients are diagnosed at the advanced stage of the disease where treatment options are limited and outcomes are often poor. The average five-year survival rate for patients with advanced gastric cancer in China is 9.1%, driving the urgent need for novel therapeutic options that can slow disease progression and extend lives.
The NMPA's approval of zolbetuximab is supported by data from the global Phase III GLOW and SPOTLIGHT clinical trials which included 145 and 36 patients from mainland China, respectively. The GLOW trial evaluated zolbetuximab plus CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin) compared to placebo plus CAPOX. The SPOTLIGHT trial evaluated zolbetuximab plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) compared to placebo plus mFOLFOX6. Treatment with zolbetuximab was shown to provide statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to other standard of care chemotherapies in eligible patients with gastric and GEJ cancers. In the GLOW trial, a median PFS of 8.21 months was achieved with zolbetuximab plus CAPOX as first-line treatment versus 6.80 months with placebo plus CAPOX. The median OS was 14.39 months versus 12.16 months in the respective treatment groups. Similar efficacy results were seen in the SPOTLIGHT trial, where the median PFS was 10.61 months versus 8.67 months, and the median OS was 18.23 months versus 15.54 months, with zolbetuximab plus mFOLFOX6, compared to placebo plus mFOLFOX6. In both the GLOW and SPOTLIGHT 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.
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