Innovent Biologics has announced that its drug candidate IBI343, a CLDN18.2-targeted antibody-drug conjugate (ADC) with a topoisomerase I inhibitor payload, has successfully met the primary endpoint in a pre-specified interim analysis of its international Phase III clinical trial for advanced gastric cancer.
The trial, known as G-HOPE-001, demonstrated that IBI343 showed outstanding efficacy along with a favorable safety and tolerability profile in this patient population.
Based on these positive clinical outcomes, the company has submitted a New Drug Application for IBI343 to China's National Medical Products Administration, which has been accepted and granted priority review status.
The application seeks approval for IBI343 to treat patients with locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma who have undergone at least two prior lines of systemic therapy.
IBI343 represents the first CLDN18.2-targeted ADC drug to have a regulatory application for review accepted globally.
The G-HOPE-001 study is an international, multicenter, randomized, open-label Phase III trial conducted in China and Japan, designed to evaluate the efficacy and safety of IBI343 monotherapy compared to investigator's choice of treatment.
The primary endpoints of the study are progression-free survival and overall survival.
The clinical trial data is planned for future presentation at academic conferences or publication in scientific journals.
Patients with advanced gastric cancer often face a poor prognosis following initial treatments, with rapid disease progression and a lack of effective later-line options, leading to a median expected survival of only about six months and a significant unmet clinical need.
The successful achievement of the primary endpoint at the first interim analysis of this pivotal international Phase III study and the subsequent acceptance of its application for regulatory review by the NMPA marks a significant breakthrough in targeted, precision therapy for gastrointestinal cancers.
The company anticipates that, if approved, IBI343 could offer a new standard-of-care treatment option for patients with advanced gastrointestinal tumors, driven by its superior efficacy and manageable safety profile.
This advancement has the potential to upgrade the precision diagnosis and treatment system for gastrointestinal cancers domestically, offering patients the prospect of longer survival and an improved quality of life.
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