
Few pancreatic Gleams of hope for Vyloy

Astellas’s Claudin18.2-targeting MAb Vyloy has flunked the mid-stage Gleam trial in first-line pancreatic cancer, but the company has already moved on to other modalities. Vyloy is FDA approved as part of a chemo combo for first-line gastric cancer, but only in patients with 75% or higher Claudin18.2 expression. Gleam, which compared Vyloy plus Abraxane and gemcitabine against Abraxane/gemcitabine alone, was Astellas’s sole phase 2 foray outside gastric cancer, according to OncologyPipeline, and failed to meet its primary endpoint of overall survival, Astellas said on Tuesday. The company has a phase 1 first-line pancreatic cancer trial ongoing, testing Vyloy plus another chemo regimen, mFolfirinox, but in an interview with ApexOnco the group’s head of oncology development, Moitreyee Chatterjee-Kishore, highlighted a different agent, the T-cell engager ASP2138. That project is in a phase 1 trial in gastric and pancreatic cancers; in the latter, monotherapy is being tested in relapsed disease, and an mFolfirinox combo in the front line. A phase 1 study of ASP2138 in neoadjuvant pancreatic cancer, followed by adjuvant chemo, is also under way. In addition, Astellas has a Claudin18.2-directed ADC, the Evopoint-originated ASP546C, whose phase 1/2 solid tumour trial includes pancreatic patients.
Astellas’s Claudin18.2-targeting assets in pancreatic cancer
Project | Modality | Trial | Setting | Regimen | Note |
---|---|---|---|---|---|
Vyloy | MAb | Ph2 Gleam | 1st-line pancreatic cancer, Claudin18.2 expression ≥75% | + Abraxane + gemcitabine, vs Abraxane + gemcitabine | Failed to meet primary OS endpoint Oct 2025 |
Vyloy | MAb | Ph1 8951-CL-5203 | 1st-line pancreatic cancer, Claudin18.2 expression ≥75% | + mFolfirinox | Completes Jul 2026 |
ASP2138 | T-cell engager | Ph1 2138-CL-0101 | Pancreatic & gastric cancers | 2nd-line pancreatic monotx; 1st-line pancreatic + mFolfirinox | Gastric cancer data at ESMO 2025; pancreatic results at a later date |
ASP2138 | T-cell engager | Ph1 2138-CL-0102 | Perioperative pancreatic cancer | Neoadjuvant ASP2138 + adjuvant chemo | Completes Nov 2027 |
ASP546C | ADC | Ph1/2 XNW27011-I/II-01 (China) | Solid tumours | Monotx | Gastric cancer data at ASCO 2025 |
Source: OncologyPipeline.
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