'Vyloy' to expand treatment options for gastric cancer

Cumulative subgroup analysis from the POTLIGHT‧GLOW study reconfirms its effects on Korean patients

Concerns about companion diagnostics, which is used to diagnose Claudin-18.2, have been resolved. Companion diagnostics are being assessed as a new health technology

Has applied for reimbursement in October with plans to launch as non-reimbursed drug in January…"anticipating its many uses"

Vyloy (active ingredient: zolbetuximab), a Claudin-18.2-targeting gastric cancer therapy, is rising as the new treatment option for stage 4 gastric cancer despite an issue related to companion diagnostics.

 

As the number of newly diagnosed patients with Claudin-18.2 increases in clinical practices, the drug will be more widely used from the early next year when it launches as non-reimbursed.

 

Vyloy logo

Vyloy is the first and only Claudin-18.2-targeted treatment.

 

A monoclonal antibody that is designed to work by binding to It binds to Claudin-18.2, a protein expressed in the stomach.

 

In South Korea, Vyloy was approved by the Ministry of Food and Drug Safety (MFDS) as a 'First-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients with CLDN18.2-positive, HER2-negative unresectable, locally advanced, or metastatic gastric adenocarcinoma or esophageal cancer.' It is gathering attention from experts since a new targeted treatment option for stage 4 gastric cancer has emerged decades after the introduction of 'trastuzumab'-based therapy for HER2-positive patients.

 

At the Korean Society of Medical Oncology-American Association for Cancer (AACR) joint symposium held last month, two accounts of Phase 3 clinical trials were presented.

 

The SPOTLIGHT and GLOW studies, which conducted sub-group analysis of Korean patients, show that the drug has reduced the risk of death by half in patients with locally advanced and metastatic gastric cancer.

 

The Vyloy group had a median progression-free survival (PFS) of 12.8 months compared to 8.1 months of the placebo group, which shows that both groups had longer PFS than all patient groups.

 

12‧24 months PFS for the Vyloy group were 53% and 30%, and those for the placebo group were 32% and 23%.

 

Additionally, the Vyloy group had a median overall survival of 30.0 months, twice longer than the 15.8 months of the placebo group.

 

12‧24 months overall survival for the Vyloy group was 78% and 54%, whereas those for the placebo group were 65% and 34%, demonstrating that the Vyloy group's death risk was lower by 50%.

 

"The introduction of Vyloy, targeting the new biomarker for gastric cancer Claudin-18.2, will bring paradigm shift of the treatment outcome of locally advanced or metastatic gastric cancer with limited treatment options until now in South Korea," Dr.

 

Keun-Wook Lee, Professor in the Department of Oncology at Seoul National University Bundang Hospital.

 

The drug's clinical application in South Korea was likely to be delayed as a companion diagnostic (CDx) used to diagnose Claudin-18.2 has been considered for assessment as a new health technology.

 

However, the drug is categorized as having 'companion diagnostic pricing (Level 1).' "The pathology department states that Level2 companion diagnostic pricing is needed for the drug that requires companion diagnostic.

 

However, now, patients can be readily treated with the drug as Level1," Professor A from a tertiary general hospital, who requested to remain anonymous, said.

 

In other words, If Vyloy's companion diagnostics had been assessed as a new health technology, the drug's entry into the domestic market would have been delayed by over one year.

 

However, such concerns have now been resolved.

 

Clinical anticipates Vyloy's prescription to be made in early 2025 when Vyloy launches in South Korea.

 

"Diagnosis reveals that Claudin-18.2 is more frequent than expected with 3-4 individuals out of 10 new patients," Professor A said.

 

"We expect the drug to be in stock by the end of January or February.

 

Its use in patient treatment is expected to be higher."