Astellas Pharma has achieved a landmark FDA approval for its new drug, Vyloy, designed to treat a rare form of gastrointestinal cancer targeting the protein claudin 18.2 (CLDN18.2). This approval marks Vyloy as the pioneer in a novel class of oncology drugs aimed specifically at combating gastric or gastroesophageal junction (GEJ) adenocarcinoma. Vyloy, or zolbetuximab, is geared towards adults with advanced cases of these cancers, specifically those that do not express the HER2 protein but are positive for CLDN18.2 – a protein predominantly found and overexpressed in stomach cell cancers, making it an ideal target for this treatment.
Gastric and GEJ adenocarcinoma form at the junction where the esophagus meets the stomach, and while considered among the rarer types of cancer in the U.S., with an estimated 130,263 people living with this condition, the need for targeted therapies is substantial. Vyloy works by binding to CLDN18.2, triggering immune responses to destroy the cancer cells expressing this specific protein.
Vyloy offers a new hope particularly to those with HER2-negative tumors, who have fewer treatment options compared to patients whose cancers are HER2-positive. Prior to Vyloy, HER2-positive cancers could be treated with drugs like Roche’s Herceptin or the antibody drug conjugate Enhertu from AstraZeneca and Daiichi Sankyo.
The FDA’s endorsement of Vyloy was backed by persuasive evidence from two Phase 3 clinical trials. These trials showcased significant improvements both in progression-free survival and overall survival rates for patients on Vyloy combined with standard chemotherapy regimes compared to those on placebo and chemotherapy alone. Common side effects identified during the trials included nausea, vomiting, and decreased appetite.
Dr. Samuel Klempner of Harvard Medical School and Massachusetts General Hospital highlighted the approval as a significant advancement for front-line treatment decision-making and addressing the unmet medical needs of patients with advanced gastric and GEJ cancers. This approval brings a new mode of action and therapeutic pathway to the table for oncologists and patients alike.
Initially slated for an earlier FDA decision, Vyloy faced a setback when the agency rejected the application due to issues with a third-party manufacturer. However, after addressing these concerns, approval was secured ahead of the rescheduled November 9 decision date. Alongside Vyloy, the FDA also sanctioned a Roche companion diagnostic tool that helps identify eligible patients for this treatment.
Financially, Astellas secured Vyloy through a €422 million acquisition ($462 million) of Ganymede Pharmaceuticals in 2016, with further payments of up to €860 million ($930 million) tied to developmental and commercial milestones. Now approved in the U.S., Vyloy has also received approvals in Japan, the United Kingdom, South Korea, and the European Union, expanding its global footprint substantially.
Interest in targeting CLDN18.2 extends beyond Astellas. AstraZeneca has recently engaged in a deal for a phase 3 study of a CLDN18.2-targeting antibody drug conjugate, originally developed by KYM Biosciences. Boston-based Elevation Oncology is also exploring this target with their early-stage ADC in various advanced solid tumors. Similarly, Merck KGaA entered a deal in 2023 that could enable it to license a potential ADC targeting CLDN18.2 being developed by Jiangsu Hengrui Pharmaceuticals.
These developments mark a significant stride in the precision medicine approach to treating complex gastrointestinal cancers, and the further exploration and validation of CLDN18.2 as a therapeutic target could usher in a new era of targeted biologic therapies in the oncology landscape.
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