Akeso Presents Positive Data Of Cadonilimab Regimen In Resectable Gastric Cancer At ESMO Asia 2025

Akeso reported encouraging Phase II COMPASSION-25 data presented at ESMO Asia showing cadonilimab (a PD-1/CTLA-4 bispecific) plus SOX as neoadjuvant therapy produced a pathologic complete response (pCR) rate of 28.6% overall and 50% with the Q3W dosing regimen, with pathologic response rates of 71.4% overall (85.7% Q3W), universal R0 resections among operated patients, and substantial primary (85.7%) and nodal (75%) downstaging; safety was consistent with known SOX and checkpoint inhibitor profiles and no new adverse events were seen. Akeso is advancing pivotal Phase III COMPASSION-33 and other trials including a cadonilimab–pulocimab program for later-line disease; cadonilimab is already approved in China for first-line advanced gastric cancer, and if Phase III confirms these signals the regimen could become a new perioperative standard—Akeso shares closed down 4.02% at $119.40.

Analysis

Akeso reported Phase II COMPASSION-25 results for cadonilimab plus SOX as neoadjuvant therapy in resectable gastric/gastroesophageal junction adenocarcinoma presented at ESMO Asia. The trial achieved a pathologic complete response (pCR) rate of 28.6% overall and 50% with the Q3W dosing regimen, with pathologic response rates of 71.4% overall and 85.7% in the Q3W cohort; all patients who underwent surgery achieved R0 resections.

Pathologic complete response is described in the release as the gold‑standard surrogate for neoadjuvant efficacy and long‑term survival, and the dataset showed substantial tumor downstaging (85.7% primary, 75% nodal), strengthening the clinical signal. Safety was reported as consistent with known SOX chemotherapy and checkpoint inhibitor profiles with no unexpected adverse events, supporting tolerability in the perioperative setting.

Akeso is progressing to the pivotal Phase III COMPASSION-33 and additional perioperative studies and is running a Phase III cadonilimab–pulocimab study for immune‑therapy resistant advanced gastric cancer; cadonilimab already has China approval in first‑line advanced gastric cancer, which could facilitate regulatory discussions if Phase III confirms benefit. Market reaction was muted to negative despite the data—shares closed down 4.02% at $119.40 and have traded between $54 and $179 over the past 12 months—highlighting binary upside tied to pivotal confirmation and program execution.

Key Decisions for Investors

• Consider selective accumulation on the recent pullback for risk‑tolerant investors given the encouraging Phase II pCR and response signals, but limit position size because approval and commercial upside depend on COMPASSION-33 confirmation
• Prioritize monitoring of COMPASSION-33 and the cadonilimab–pulocimab Phase III program, watch for specific safety readouts and any regulatory filings leveraging the existing China approval as near‑term catalysts
• Conservative investors should hedge exposure or wait for pivotal readouts before adding material weight, or take profits on strength given the stock's wide 12‑month $54–$179 trading range and the binary nature of oncology pivotal outcomes