#China #Yantai #RemeGen #Disitamab Vedotin #HER2 Gastric Cancer

Transforming Gastric Cancer Treatment: Disitamab Vedotin's Promising Outcomes

On June 2, 2025, an oral presentation at the ASCO Annual Meeting unveiled promising findings regarding disitamab vedotin (DV) as a first-line therapy for gastric cancer expressing HER2. Dr. Lin Shen from Beijing Cancer Hospital reported on a Phase 2 clinical trial that evaluated the efficacy and safety of DV, which is developed by RemeGen Co., Ltd., alongside toripalimab (PD-1) and a combination of CAPOX or trastuzumab. This combination method aims to benefit patients suffering from locally advanced or metastatic gastric cancer, especially those who did not respond to conventional targeted therapies.

The results indicate a significant improvement in efficacy when combining DV with PD-1 and chemotherapy compared to standard treatment protocols. Among patients with HER2-overexpressing gastric cancer, the data showed objective response rates (ORR) of 66.7% for standard treatment, escalating to 82.4% and 68.8% when administered with DV. Remarkably, there was a 54% reduction in disease progression risk with a median progression-free survival (mPFS) of 14.1 months.

In contrarily affected patients with HER2-low-expressing gastric cancer, DV combined with PD-1 and CAPOX yielded an ORR of 72.0%, outperforming the traditional PD-1 plus CAPOX therapy, which only reached 47.8%. With promising mPFS results of 9.9 months versus 7.2 months, these findings highlight the potential of DV to become a standard therapy in this subgroup of patients.

The clinical study's multi-cohort design is significant, as it facilitates customized treatment approaches for gastric cancer patients with varying HER2 expression levels. The trial's outcome suggests that for those with HER2-high expression, the combination of DV and PD-1 plus trastuzumab could set a new standard for first-line treatment. Meanwhile, patients with lower HER2 expression levels might find a reliable treatment gap filled by the DV combination with PD-1 and chemotherapy.

This groundbreaking trial marks the first exploration of a triple combination therapy using HER2-targeted drug conjugates with PD-1 inhibitors and additional targeted medication in gastric cancer treatment. Following these encouraging results, a phase 3 clinical study is already underway focusing on HER2-median/low-expressing gastric cancer, aiming to further define the efficacy of the DV combination therapy with 616 participants planned for enrollment.

Gastric cancer stands as the fifth most prevalent malignant tumor globally, with China contributing substantially to these statistics. Currently, traditional treatment options, particularly trastuzumab, only benefit those with high HER2 expression. This gap leaves many patients, especially those with low or median HER2 levels, without effective therapy options. The DV's ability to deliver targeted attack not only on cancer cells with high HER2 but also on adjacent cells with lower expression is a game-changer.

Preclinical research has further demonstrated how DV, when used in conjunction with PD-1 inhibitors and trastuzumab, can largely enhance anti-tumor activity. Overall, these findings underscore a monumental step in reshaping the landscape of gastric cancer therapies, aiming to give renewed hope to those impacted by this challenging disease.