Akeso, Inc. (AKEST) announced encouraging results from its Phase II COMPASSION-25 trial evaluating Cadonilimab for patients with resectable gastric or gastroesophageal junction adenocarcinoma at Tuesday's ESMO Asia Congress in Hong Kong.
The study assessed Cadonilimab, the first PD-1/CTLA-4 bispecific antibody, in combination with SOX regimen (oxaliplatin + tegafur/gimeracil/oteracil) as neoadjuvant therapy.
Results demonstrated a pathologic complete response or pCR rate of 28.6% across all evaluable patients, with the Cadonilimab Q3W dosing regimen achieving a notably higher pCR rate of 50 percent.
Pathologic complete response, defined as the absence of viable tumor cells in both the primary tumor site and regional lymph nodes following surgical resection, is considered the gold standard surrogate endpoint for evaluating neoadjuvant treatment efficacy and predicting long-term survival.
The trial also showed pathologic response rate of 71.4% overall, rising to 85.7% in the Q3W regimen group.
All patients who underwent surgery achieved R0 resections, underscoring the regimen's ability to improve surgical outcomes.
Akeso said tumor downstaging was significant as well, with 85.7% achieving primary tumor downstaging and 75% achieving nodal downstaging.
Safety findings were consistent with the known profiles of SOX chemotherapy and immune checkpoint inhibitors, with no unexpected adverse events reported.
Akeso noted that Cadonilimab's dual PD-1/CTLA-4 blockade provides stronger anti-tumor activity than PD-1 monotherapies and could establish a new standard for perioperative immunotherapy in gastric cancer.
The company is advancing the pivotal Phase III COMPASSION-33 study to confirm these results, alongside additional trials exploring Cadonilimab plus SOX in perioperative setting to treat resectable G/GEJ adenocarcinoma, this regimen could set a new standard for perioperative gastric cancer treatment.
The company is also advancing a Phase III study of Cadonilimab in combination with pulocimab, a VEGFR-2 inhibitor, for immune therapy-resistant advanced gastric cancer, which is expected to provide new treatment options for later-line patients.
Cadonilimab has already been approved in China as a first-in-line treatment for advanced gastric cancer in combination with chemotherapy, with demonstrated survival benefits across PD-L1 expression levels.
Akeso closed yesterday's trading at $119.40, down 4.02%. Over the past 12 months, the stock has traded between $54 and $179.
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