Camrelizumab/Nab-POF Combo Increases R0 Resection Rates in Gastric/GEJ Cancer

The combination of camrelizumab and nab-paclitaxel (Abraxane), oxaliplatin, and fluorouracil (Nab-POF) was associated with high rates of conversion to R0 resection, as well as high 3-year survival rates, in patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Findings from the phase 2 FDZL-001 trial (NCT04510064), which were presented at the 2025 ASCO Gastrointestinal Cancers Symposium, showed that R0 resection rate was achieved in 75.0% of patients. A pathological complete response (pCR) was noted in 23.1% of patients, the overall response rate (ORR) was 88.5%, and the disease control rate (DCR) was 98.1%. The total CR rate comprising clinical CR plus pCR was 23.1%.

The median overall survival (OS) was not reached (NR; 95% CI, 25.4-not evaluable [NE]). The 3-year OS rate was 62.8% (95% CI, 41.6%-78.0%). The median progression-free survival (PFS) was NR (95% CI, 17.0-NE). At 3 years, the PFS rate was 56.9% (95% CI, 45.7%-86.3%).

“[The FDZL-001] trial preliminarily shows promising results providing a new conversion drug treatment option for patients with initially unresectable, locally advanced and limited metastatic gastric or GEJ adenocarcinoma,” Qirong Geng, MD, from the Department of Medical Oncology, Fudan University Shanghai Cancer Center in China, stated during the presentation.

A total of 52 patients were enrolled, with 73.1% being male, and 50.0% each being younger than 65 years or older than 65 years. An ECOG performance status of 0 or 1 was noted in 100% of patients, and 78.8% of patients had metastatic disease.

Primary tumor locations included proximal gastric (34.6%), distal gastric (34.6%), gastric body (23.1%), and multicentric (7.7%). Additionally, most patients did not have liver metastases (53.8%), and none had lung metastases.

Patients were given 200 mg of camrelizumab plus 125 mg/m2 of nab-paclitaxel and 85 mg/m2 of oxaliplatin. If patients had HER2-positive disease, they were given trastuzumab (Herceptin) at 6 mg/kg for the first dose then at 4 mg/kg thereafter. Fluorouracil was given at 2.4 g/m2.

The primary end point was R0 resection rate. Key secondary end points included ORR, DCR, pCR rate, total CR rate, PFS, and OS.

Overall, 53 patients were given the study treatment with or without trastuzumab, among 43 had HER2-negative disease, and 10 had HER2-positive disease. In total, 52 evaluable patients were included in the per protocol set, with 39 continuing on to surgery and 39 continuing prescheduled post-operation treatment and follow-up. Of note, 7 patients died during the analysis.

The subgroup analysis found that there were no differences in OS and PFS between patients with HER2-positive and HER2-negative disease with locally advanced and limited metastatic tumors. Investigators also highlighted that the 3-year OS rate was above 50% for patients who had HER2-negative disease or limited metastatic disease.

Regarding safety, all-grade treatment-related adverse effects (TRAEs) occurred in 100% of patients, and grade 3/4 TRAEs were reported in 42.3% of patients. The most common hematologic TRAEs were anemia (any-grade, 86.5%; grade 3/4, 3.8%), neutropenia (78.8%; 36.5%), leukopenia (63.5%; 9.6%), and thrombocytopenia (48.1%; 3.8%).

Nonhematologic TRAEs included reactive cutaneous capillary endothelial proliferation (any-grade, 63.5%; grade 3/4, 0.0%), increased aspartate aminotransferase levels (51.9%; 1.9%), increased alanine aminotransferase levels (50.0%; 1.9%), rash (21.1%; 1.9%), and febrile neutropenia (0.0%; 3.8%).

Any-grade immune-related AEs occurred in 19.2% of patients, and 3.8% of patients had grade ¾ immune-related AEs. The most common immune-related AEs included adrenal insufficiency (any-grade, 1.9%; grade 3/4, 1.9%) and dermatitis (1.9%; 1.9%).

Reference

Geng Q, Feng W, Huang H, et al. Conversion effects of PD-1 inhibitor camrelizumab (cam) combined with Nab-POF regimen in patients (pts) with initially unresectable locally advanced or limited metastatic gastric or gastroesophageal junction adenocarcinoma: FDZL-001 trial. J Clin Oncol. 2025;43(4):334. doi:10.1200/JCO.2025.43.4_suppl.334