On December 31st,China’s National Medical Products Administration (NMPA) has approved VYLOYTM (zolbetuximab), 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 (HER2)-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.
The NMPA’s approval of zolbetuximab is supported by data from the global Phase 3 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.
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.
In the combined analysis, the median progression-free survival was 9.2 months in the zolbetuximab group and 8.2 months in the placebo group (hazard ratio for progression or death, 0.71; 95% confidence interval [CI], 0.61 to 0.83). A total of 377 of 537 patients (70.2%) in the zolbetuximab group and 424 of 535 patients (79.3%) in the placebo group died. The median overall survival was 16.4 months in the zolbetuximab group and 13.7 months in the placebo group (hazard ratio for death, 0.77; 95% CI, 0.67 to 0.89). The types of subsequent anticancer therapies were balanced between the treatment groups.
At present, there are still many clinical trials of new anti-cancer technologies in China seeking patients. Consultation on new drugs and technologies, you can contact Beijing South Region Oncology Hospital International Department.
Phone Number：4008803716
Email：myimmnet@163.com
REFERENCES
1.国家药监局批准注射用佐妥昔单抗上市 (nmpa.gov.cn)
Post time: Jan-09-2025