Akeso’s candidate therapy cadonilimab, in combination with chemotherapy, showed encouraging results as a first-line treatment for advanced pancreatic cancer in the Phase 2 COMPASSION-26 study.
The strongest outcomes were seen in people with locally advanced pancreatic ductal adenocarcinoma (PDAC), who lived a median of 23.4 months and went a median of 11.1 months without their cancer worsening, according to a company press release.
Among all treated patients, about a third had their tumors shrink (objective response rate), and almost all had their cancer either shrink or stop growing (disease control rate). No new safety concerns were reported. While encouraging, the trial did not include a control group given standard chemotherapy alone for direct comparison.
The results were shared in a poster, titled “A phase II, multicenter, open-label study (COMPASSION-26) of cadonilimab, a PD-1/CTLA-4 bispecific antibody, combined with chemotherapy (chemo) as first-line therapy for advanced pancreatic ductal adenocarcinoma (PDAC),” at the 2026 American Association for Cancer Research (AACR) Annual Meeting, held April 17-22 in San Diego.
Cadonilimab designed to block 2 key proteins
PDAC is the most common type of pancreatic cancer, accounting for more than 80% of cases, and it is often diagnosed when surgery is no longer possible.
Cadonilimab is a bispecific antibody designed to block PD-1 and CTLA-4, two immune checkpoint proteins that act like brakes and can weaken the activity of key immune cells, called T-cells. By blocking both checkpoints simultaneously, the therapy aims to help the immune system recognize and attack cancer cells. Cadonilimab is already approved in China for certain cervical and gastric cancers.
The open-label Phase 2 COMPASSION-26 study (NCT05859750) is testing cadonilimab in people with unresectable locally advanced (meaning the cancer has spread nearby but not far away) or metastatic (meaning the cancer has spread to part of the body far from where it first started) PDAC who have not received prior systemic therapy, a group with limited treatment options and generally poor outcomes.
Patients received cadonilimab at 6 mg/kg or 10 mg/kg every two weeks, together with a chemotherapy combo of gemcitabine plus nab-paclitaxel, given every four weeks. The study’s primary endpoint was objective response rate using RECIST 1.1, a standard assessment method.
Survival findings favored patients with locally advanced disease
As of the Oct. 20, 2025, data cutoff, 59 patients had been enrolled, with a median follow-up of almost two years (24.7 months). Most participants were men (61%; median age 63.1), and 59.3% had distant metastases.
A total of 56 patients (95%) had at least one post-baseline tumor evaluation and were evaluable for efficacy.
Of the 56 patients, 19 patients responded, representing an objective response rate of 33.9%. In 54 of those 56 patients, the disease remained controlled, representing a disease control rate of 96.4%. Response rates were reported as similar in the locally advanced and metastatic groups.
The survival findings favored patients with locally advanced disease. In this group, the median duration of response was 7.46 months, compared with 4.8 months in those with metastatic disease.
Median progression-free survival, or the median time patients lived without their cancer progressing, was 11.1 months in locally advanced disease versus 7.2 months in patients with metastatic disease. Also, in patients with locally advanced disease, the median overall survival was 23.4 months versus 10.5 months in those with metastatic disease.
For the full study population, median progression-free survival was 8.5 months and median overall survival was 13.8 months.
With longer follow-up, patients whose cancer was locally advanced did better than those whose cancer was metastatic. For patients with locally advanced cancer, about 92% were alive after one year, and about 44% were alive after two years. For patients with metastatic cancer, 40% were alive after one year, and about 14% were alive after two years.
Across all patients, the one-year overall survival rate was 61.0%, the two-year overall survival rate was 26.2%, and the six-month progression-free survival rate was 69.2%. Furthermore, results revealed a six-month progression-free survival rate of 89.9% in locally advanced disease, compared with 54.2% in metastatic disease.
A safety analysis showed that all patients had treatment-related side effects, but according to Akeso, these were manageable, and no new safety signals were observed.
The most common treatment-related adverse events were anemia (89.8%) and decreases in neutrophils (96.6%), white blood cells (84.7%), and platelets (76.3%). Other commonly reported side effects included rash, higher liver enzymes, hair loss, fever, fatigue, and itching.
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