“Metastatic gastric cancer has been slow to make therapeutic progress due to the limitations of targeted therapies, and targeted therapies have underserved HER2-negative patients in particular. While Vyloy is notable for targeting a novel biomarker in Claudin 18.2, the progression-free survival and overall survival seen in the SPOTLIGHT and GLOW studies are game-changing innovations in treating metastatic gastric cancer.”
Professor Kim Hyung-don of the Department of Medical Oncology at Asan Medical Center said this while discussing the clinical value of Vyloy (zolbetuximab) during a launching event at Astellas Pharma Korea headquarters in Seoul last Thursday.
Professor Kim Hyung-don of the Department of Medical Oncology at Asan Medical Center delivered a lecture last Thursday on the clinical value of Vyloy at Astellas Pharma Korea headquarters in Seoul. (Courtesy of Astellas Pharma Korea)
The in-house event, themed "Vyloy: A New Treatment Innovation for Metastatic Gastric Cancer Patients," was organized to highlight the significance of Vyloy's launch and support successful treatment journeys for gastric cancer patients.
“Notably, the expression rate of Claudin 18.2 in Korean patients is about 40 percent, indicating that the clinical value of Vyloy is significant. At Asan Medical Center, several patients in our compassionate use program have already shown meaningful clinical responses to treatment with Vyloy. We believe that expanded access, including insurance reimbursement, will enable us to take the next step in treating metastatic gastric cancer in Korea,” Professor Kim said.
Vyloy is the first targeted therapy approved for HER2-negative patients in the first-line treatment of metastatic gastric cancer and the world's first approved anticancer drug targeting Claudin 18.2. Metastatic and unresectable advanced gastric cancer is associated with a median survival of about one year, making biomarker-based targeted therapies that can improve survival important. While HER2 has been recognized as an important therapeutic target, about 90 percent of patients with metastatic gastric cancer are HER2-negative, creating a high unmet medical need for targeted antitumor therapies.
In the SPOTLIGHT study, the combination of Vyloy and mFOLFOX6 (oxaliplatin, leucovorin, and fluorouracil) achieved a median progression-free survival (mPFS) of 10.61 months, compared to 8.67 months in the placebo arm, and a median overall survival (mOS) of 18.23 months, compared to 15.54 months in the placebo arm.
In the GLOW study, the combination of Vyloy and CAPOX (capecitabine and oxaliplatin) reduced the risk of disease progression or death by about 31 percent, with an mPFS of 8.21 months and an mOS of 14.39 months, compared to 12.16 months in the placebo arm, confirming a positive treatment effect.
Vyloy was approved in Korea last September and launched on March 3. It won approval from the Ministry of Food and Drug Safety (MFDS) as a first-line treatment for patients with Claudin 18.2-positive, HER2-negative, unresectable locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma in combination with fluoropyrimidine-based and platinum-based chemotherapy.
“The introduction of Vyloy in Korea is not just a new drug launch, but a historic moment that opens a new chapter in treating metastatic gastric cancer,” Astellas Pharma Korea General Manager Kim Jun-il said. “It is especially significant because it enables personalized treatment for HER2-negative patients who have not previously benefited from targeted therapies in Korea, where the incidence of gastric cancer is high.”
Kim continued, “The Wall of Hope, created by Astellas Pharma Korea executives and employees at this event, symbolizes our commitment to support patients on their new treatment journey and continue our efforts to improve access and survival rates. We will do our best to help Vyloy make a real difference in the lives of metastatic gastric cancer patients in Korea.”