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Zolbetuximab shows promise in CLDN18.2-positive advanced gastric, GEJ adenocarcinomas

07 Aug 2019

Zolbetuximab monotherapy exhibits antitumour activity with acceptable tolerability profile in patients with Claudin 18.2 (CLDN18.2)-positive advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinomas, according to the results of a phase IIa trial.

A total of 54 patients with advanced gastric, GEJ or oesophageal adenocarcinomas with moderate-to-strong CLDN18.2 expression in ≥50 percent of tumour cells received zolbetuximab intravenously every 2 weeks for five planned infusions.

These patients were consecutively enrolled in three cohorts. Cohorts 1 (n=4) and 2 (n=6) were small lead-in groups evaluating the feasibility of repeated administration of zolbetuximab monotherapy at two dose levels (300 mg/m2 as safety run-in and 600 mg/m2 as targeted dose). Cohort 3 (n=44) was a larger dose-expansion arm of the 600 mg/m2 dose. Three patients in cohort 1 and 25 patients in cohorts 2 and 3 received at least five infusions.

The primary endpoint was objective response rate (ORR; complete and partial response), while secondary endpoints included clinical benefit (ORR plus stable disease), progression-free survival, safety/tolerability, and zolbetuximab pharmacokinetic profile.

In the overall population, 43 patients had available antitumour activity data. Four patients achieved partial response (ORR, 9 percent) and six (14 percent) had stable disease, yielding a clinical benefit rate of 23 percent.

In the subgroup of patients with moderate-to-high CLDN18.2 expression in ≥70 percent of tumour cells, ORR was 14 percent (n=4/29).

Treatment-related adverse events occurred in 81.5 percent of patients (44 of 54). Commonly reported events were nausea (61 percent), vomiting (50 percent) and fatigue (22 percent).

Zolbetuximab (formerly known as IMAB362) is a first-in-class monoclonal antibody that binds to CLDN18.2 and can induce immune-mediated lysis of CLDN18.2-positive cells. The findings support CLDN18.2 as a target for immune-mediated antitumour therapy and promote further investigation of the drug, specifically in combination with chemotherapy, as a potential treatment for patients with advanced gastric cancer, the researchers said.

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Most Read Articles
Pearl Toh, 6 days ago
Having migraine during midlife appears to be associated with a higher risk of developing dementia in later life, according to a large population-based longitudinal Danish study presented at the AHS* 2020 Virtual Meeting, indicating that migraine may be a risk factor for dementia.
5 days ago
Patients with psoriatic arthritis (PsA) often suffer from liver abnormalities, which are associated with higher body mass index (BMI), daily consumption of alcohol, more severe disease, and some therapies, according to a recent study.
Christina Lau, 4 days ago

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The type of face mask matters, in addition to sterilization method, in influencing subsequent filtration efficiency after sterilization process for reuse, a new study finds.