Gastroesophageal, Pancreatic, and Hepatobiliary – Oral Abstract Session 1

This daily highlight in GI cancer from ASCO 2025 is presented by Prof Jeroen Dekervel (University Hospitals Leuven), who discusses the key findings from the oral abstract session on gastroesophageal, pancreatic, and hepatobiliary cancers.

In a first study, Prof Dekervel reports on the CHECKMATE 577 trial, which investigated adjuvant nivolumab in oesophageal cancer patients who did not achieve a complete pathological response after chemoradiotherapy and surgery, and was reported at ASCO. The trial had previously shown a statistically significant DFS benefit with adjuvant nivolumab. The new data presented focused on OS after a median follow-up of 78 months. The OS data showed a clear trend favouring nivolumab, but it did not reach statistical significance. Subgroup analysis revealed a more pronounced benefit in patients with squamous cell carcinoma, despite their representing a smaller portion of the study population. There is also a shift towards perioperative chemotherapy for adenocarcinoma of the oesophagus, gastroesophageal junction, and stomach, informed by other studies such as ESOPEC. However, for squamous cell carcinoma, the approach remains to combine chemoradiotherapy with adjuvant nivolumab when there is no complete pathological response. 

The LEAP-015 trial focused on gastric cancer in the first-line metastatic setting. It explored whether adding lenvatinib and pembrolizumab to chemotherapy could improve OS. The trial included hundreds of patients and had a safety lead-in phase to address the known additional toxicities of lenvatinib when combined with chemotherapy and immunotherapy. The primary endpoints were OS and PFS. While the trial did find a significant improvement in PFS for the combination treatment, OS did not reach statistical significance. The combination regimen showed a trend towards improved survival, but this was not strong enough to change practice. The added toxicities of lenvatinib and pembrolizumab also weighed against using this approach routinely. Given the absence of a statistically significant OS  benefit, this trial’s results do not support adopting this triple combination as a new standard.

A new trial focusing on neoadjuvant chemotherapy for resectable biliary tract cancer was discussed, the GAIN trial. Primary resection is currently the standard of care, often followed by adjuvant chemotherapy, although the supporting data for adjuvant therapy are limited. This phase III trial, conducted by a German group, aimed to assess whether adding neoadjuvant GemCis chemotherapy would improve OS compared to standard treatment. The study initially planned to include 300 patients, but managed to randomise only 68 due to challenges in patient accrual. Patients were assigned to either neoadjuvant GemCis followed by surgery and adjuvant GemCis, or primary resection followed by adjuvant chemotherapy at the investigator’s discretion. Despite the small sample size, the trial demonstrated a positive trend in OS for those receiving neoadjuvant therapy. This result is encouraging for the potential role of neoadjuvant chemotherapy in this cancer type. However, the small sample size and challenges in recruitment suggest that larger studies are needed to confirm these findings.