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Disitamab vedotin plus programmed death-1 inhibitor for pre-treated HER2 overexpressed advanced gastric cancer: a
Xiao Yan1, Zhong Xie2, Kaobin Ouyang3
1Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Background:
The efficacy of pre-treated advanced gastric or gastroesophageal junction cancer (G/GEJC) with HER2 overexpressed (IHC 2+/3+) remains unsatisfactory. This retrospective real-world study aimed to analyse the safety and efficacy of disitamab vedotin (RC48) plus programmed death-1 (PD-1) inhibitor in pre-treated patients with advanced G/GEJC.
Patients And Methods:
We retrospectively reviewed consecutive patients with HER2 2+/3+ advanced G/GEJC who received RC48 plus PD-1 inhibitor or RC48 monotherapy from four Chinese hospitals (July 2021 to September 2023). ORR and DCR were estimated by logistic regression. Survival was analysed via Kaplan-Meier method and log-rank tests. Subgroup and post hoc power analyses were performed.
Results:
Fifty-seven patients were enrolled: 36 received RC48 plus PD-1 inhibitor (combination group) and 21 received RC48 alone (monotherapy group). The combination group demonstrated a significantly higher ORR than the monotherapy group (41.7% vs. 9.5%, p = 0.011). Although the DCR was not significantly different (75.0% vs. 57.1%, p = 0.162), the combination group showed a significantly prolonged mOS (13.2 months vs. 7.1 months, p = 0.040) and a trend towards longer mPFS (5.8 months vs. 2.9 months, p = 0.142). In the combination group, patients with initial HER2 3+, second-line treatment, or liver metastasis had more favourable outcomes. The incidence of grade 3-4 TrAEs was comparable between the two groups (41.7% vs. 38.1%).
Conclusions:
RC48 plus PD-1 inhibitor for pre-treated advanced G/GEJC patients with HER2 2+/3+ demonstrated superior efficacy than RC48 monotherapy and favourable safety. This combination represents a potential therapeutic strategy, but further large-scale prospective studies are still needed.
Insights
Disitamab vedotin (RC48) plus a programmed death-1 (PD-1) inhibitor significantly improved outcomes for pre-treated advanced gastric cancer patients with HER2 overexpression. This combination therapy shows promise, offering better efficacy and safety compared to RC48 monotherapy.
Area of Science:
- Oncology
- Gastroenterology
- Immunotherapy
Background:
- Pre-treated advanced gastric or gastroesophageal junction cancer (G/GEJC) with HER2 overexpression (IHC 2+/3+) has unsatisfactory treatment efficacy.
- Disitamab vedotin (RC48) is an antibody-drug conjugate targeting HER2.
Purpose of the Study:
- To evaluate the safety and efficacy of disitamab vedotin (RC48) combined with a programmed death-1 (PD-1) inhibitor in pre-treated advanced G/GEJC patients with HER2 overexpression.
- To compare this combination therapy against RC48 monotherapy in a real-world setting.
Main Methods:
- Retrospective review of 57 pre-treated advanced G/GEJC patients with HER2 2+/3+ from four Chinese hospitals (July 2021-September 2023).
- Patients received either RC48 plus PD-1 inhibitor (combination group, n=36) or RC48 monotherapy (monotherapy group, n=21).
- Objective response rate (ORR), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) were analyzed.
Main Results:
- The combination group showed a significantly higher ORR (41.7% vs. 9.5%, p=0.011) and a significantly longer median OS (13.2 months vs. 7.1 months, p=0.040) compared to the monotherapy group.
- While DCR was not significantly different (75.0% vs. 57.1%), the combination group trended towards longer median PFS (5.8 months vs. 2.9 months, p=0.142).
- Grade 3-4 treatment-related adverse events were comparable between groups (41.7% vs. 38.1%).
Conclusions:
- RC48 plus PD-1 inhibitor demonstrates superior efficacy and favorable safety in pre-treated advanced G/GEJC patients with HER2 2+/3+ compared to RC48 monotherapy.
- This combination represents a potential therapeutic strategy for this patient population.
- Further large-scale prospective studies are warranted to confirm these findings.
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