On June 10, 2024 J INTS BIO reported an update of its ongoing Phase 1 clinical study of JIN-A02, a 4th generation EGFR-TKI for NSCLC treatment, during the 3rd of June poster session of the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held at McCormick Place in Chicago, USA, from May 31 to June 4 (Press release, J INTS BIO, JUN 10, 2024, View Source;jin-a02-showed-tumor-reductions-including-brain-metastasis-in-the-ongoing-first-in-human-dose-finding-phase-1-clinical-study-302168022.html [SID1234644234]).
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This latest study update of JIN-A02 reported another tumor Partial Response (PR) in a patient in Cohort 4 (100mg daily). The first tumor Partial Response (PR) recorded in this study, was a patient in the earlier Cohort at a lower dose of 50mg daily. In addition, the first instance of brain tumor activity was recorded in Cohort 4, with a 28.6% reduction of the brain metastasis.
To-date, Partial Response (PR) has been confirmed in two patients and Stable Diseases in three other, including the patient with reduction of brain metastasis in Cohort 4 and two patients from the lower Cohorts at a lower dose.
The final patient in Cohort 4 (100mg) is expected to complete the dose-limiting toxicity (DLT) assessment period soon and thus far, no DLT has been detected. In addition, no rash, diarrhea, or cardiac toxicity (side effects commonly associated with EGFR TKIs use), has been reported in this study despite the positive efficacy signals and clinical benefits already observed. The next Cohort at 150mg daily will begin end of June.
J INTS BIO said, "It is very meaningful to be able to share key clinical results in large-scale global conferences attended by global anticancer experts and research and development officials." and "JIN-A02 is expected to be a game changer to improve the life of patients with EGFR C797S positive NSCLC, for which there is currently no approved treatment," they added. According to the company, JIN-A02 is scheduled to enter phase 2 clinical trial by the end of this year.