On June 4, Qurient, an innovative new drug company, announced that it had presented the results of a Phase 1b clinical trial of Adricetynib (Q702), a triple inhibitor targeting Axl/Mer/CSF1R, in combination with Keytruda at the American Society of Clinical Oncology (ASCO).
The clinical trial was conducted as a joint research project with MSD in the United States. The study evaluated the tolerability, safety, and recommended Phase 2 dose (RP2D) of Adricetynib in combination with Keytruda in patients with treatment-resistant gastric cancer, esophageal cancer, hepatocellular carcinoma, and cervical cancer.
Among the 29 patients who participated in the trial, no dose-limiting toxicity leading to treatment discontinuation was observed in any dose group. Of the 22 patients evaluable for efficacy, one patient with metastatic gastric cancer achieved a complete response (CR). Six patients achieved stable disease, and among them, two patients?one with gastric cancer and one with liver cancer?maintained stable disease for more than 24 weeks.
The gastric cancer patient who achieved a complete response had previously been treated with Keytruda. This case is considered to suggest the potential for Adricetynib plus Keytruda combination therapy to become a new treatment option.
Through the clinical trial, Qurient confirmed the manageable safety profile of the Adricetynib plus Keytruda combination therapy. The recommended Phase 2 dose (RP2D) was established at 120 mg, the same level as Adricetynib monotherapy. The company is currently working on identifying biomarkers to select patients who may demonstrate similar therapeutic efficacy as those who achieved complete response in gastric and liver cancers. Based on this, additional efficacy studies will be conducted in carefully selected patient groups.
Adricetynib is currently being actively developed in the field of hematologic malignancies, leveraging its superior safety and monotherapy efficacy compared to competing drugs. Beginning with a clinical trial for acute myeloid leukemia, which started dosing the first patient in February, the company plans to initiate additional trials for rare hematologic cancers and chronic graft-versus-host disease.
Nam Kiyeon, CEO of Qurient, explained, "We are working to identify biomarkers that can maximize the efficacy of Adricetynib in patients who achieve complete response, while also developing hematologic malignancy indications that could facilitate rapid regulatory approval." He added, "The data obtained from the Adricetynib plus Keytruda combination trial has brought us closer to biomarker development, and expanding into the hematologic malignancy market will maximize the value of our pipeline."
Cho Yongjun, Chairman of Donggu BioPharm, commented, "Qurient is maximizing therapeutic efficacy in solid tumors by efficiently utilizing limited resources through a biomarker-based patient selection strategy." He continued, "Focusing clinical development on indications such as hematologic malignancies and graft-versus-host disease, where the mechanism of action has been validated, is a highly rational and strategic approach to increasing the likelihood of clinical success."
He added, "Donggu BioPharm will provide comprehensive support for the successful development of Adricetynib through our strategic partnership with Qurient, and we aim to introduce new treatment options to the domestic anticancer drug market."
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