ORCID Profile
0000-0002-0928-7453
Current Organisation
University of California, San Diego
Does something not look right? The information on this page has been harvested from data sources that may not be up to date. We continue to work with information providers to improve coverage and quality. To report an issue, use the Feedback Form.
Publisher: Springer Science and Business Media LLC
Date: 18-02-2015
DOI: 10.1038/NATURE14248
Publisher: American Association for Cancer Research (AACR)
Date: 08-2023
DOI: 10.1158/1078-0432.23815995
Abstract: Supplementary Tables 1-3
Publisher: American Association for Cancer Research (AACR)
Date: 08-2023
DOI: 10.1158/1078-0432.23815995.V1
Abstract: Supplementary Tables 1-3
Publisher: American Association for Cancer Research (AACR)
Date: 08-2023
DOI: 10.1158/1078-0432.CCR-23-0092
Abstract: In this first-in-human, Phase 1, open-label, multicenter study, we evaluated JNJ-64619178, a selective and potent PRMT5 inhibitor, in patients with advanced malignant solid tumors or non-Hodgkin lymphomas (NHL). The primary objective was to evaluate the safety and to identify a recommended Phase 2 dose (RP2D) of JNJ-64619178. Adult patients with treatment-refractory advanced solid tumors or NHL and measurable disease received escalating doses of JNJ-64619178 following two schedules (Schedule A: 14 days on/7 days off Schedule B: every day on a 21-day cycle). Safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity were evaluated. Ninety patients received JNJ-64619178. Thrombocytopenia was identified as the only dose-limiting toxicity. JNJ-64619178 showed dose-proportional PK and robust target engagement, as measured by plasma symmetric dimethylarginine, across all dose levels. The objective response rate was 5.6% (5 of 90). Patients with adenoid cystic carcinoma (ACC) had an ORR of 11.5% (3 of 26) and a median progression-free survival of 19.1 months. JNJ-64619178 demonstrated manageable dose-dependent toxicity and preliminary evidence of antitumor activity in ACC and other tumor types. Plasma exposure was dose dependent, and target inhibition was maintained with intermittent and continuous dosing. On the basis of safety, clinical activity, PK, and PD findings, two provisional RP2Ds were selected: 1.5 mg intermittently and 1.0 mg once daily. Aside from ACC, clinical benefit was limited, and biomarkers to enrich for responsiveness to PRMT5 inhibition will be needed for further development.
Publisher: American Association for Cancer Research (AACR)
Date: 08-2023
DOI: 10.1158/1078-0432.23815998.V1
Abstract: Supplementary Figure 1: Overall Response Over Time on JNJ-64619178 Treatment A. Dose Cohorts 0.5 mg - 1.5 mg (schedule A& B). B. Dose Cohorts 2.0 mg - 4.0 mg (schedule A& B)
Publisher: American Association for Cancer Research (AACR)
Date: 15-09-2023
DOI: 10.1158/1078-0432.C.6769722
Abstract: AbstractPurpose: In this first-in-human, Phase 1, open-label, multicenter study, we evaluated JNJ-64619178, a selective and potent PRMT5 inhibitor, in patients with advanced malignant solid tumors or non-Hodgkin lymphomas (NHL). The primary objective was to evaluate the safety and to identify a recommended Phase 2 dose (RP2D) of JNJ-64619178. Patients and Methods: Adult patients with treatment-refractory advanced solid tumors or NHL and measurable disease received escalating doses of JNJ-64619178 following two schedules (Schedule A: 14 days on/7 days off Schedule B: every day on a 21-day cycle). Safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity were evaluated. Results: Ninety patients received JNJ-64619178. Thrombocytopenia was identified as the only dose-limiting toxicity. JNJ-64619178 showed dose-proportional PK and robust target engagement, as measured by plasma symmetric dimethylarginine, across all dose levels. The objective response rate was 5.6% (5 of 90). Patients with adenoid cystic carcinoma (ACC) had an ORR of 11.5% (3 of 26) and a median progression-free survival of 19.1 months. Conclusions: JNJ-64619178 demonstrated manageable dose-dependent toxicity and preliminary evidence of antitumor activity in ACC and other tumor types. Plasma exposure was dose dependent, and target inhibition was maintained with intermittent and continuous dosing. On the basis of safety, clinical activity, PK, and PD findings, two provisional RP2Ds were selected: 1.5 mg intermittently and 1.0 mg once daily. Aside from ACC, clinical benefit was limited, and biomarkers to enrich for responsiveness to PRMT5 inhibition will be needed for further development. /
Publisher: American Association for Cancer Research (AACR)
Date: 15-09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 15-09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 15-09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 08-2023
DOI: 10.1158/1078-0432.C.6769722.V1
Abstract: AbstractPurpose: In this first-in-human, Phase 1, open-label, multicenter study, we evaluated JNJ-64619178, a selective and potent PRMT5 inhibitor, in patients with advanced malignant solid tumors or non-Hodgkin lymphomas (NHL). The primary objective was to evaluate the safety and to identify a recommended Phase 2 dose (RP2D) of JNJ-64619178. Patients and Methods: Adult patients with treatment-refractory advanced solid tumors or NHL and measurable disease received escalating doses of JNJ-64619178 following two schedules (Schedule A: 14 days on/7 days off Schedule B: every day on a 21-day cycle). Safety, pharmacokinetics (PK), pharmacodynamics (PD), and clinical activity were evaluated. Results: Ninety patients received JNJ-64619178. Thrombocytopenia was identified as the only dose-limiting toxicity. JNJ-64619178 showed dose-proportional PK and robust target engagement, as measured by plasma symmetric dimethylarginine, across all dose levels. The objective response rate was 5.6% (5 of 90). Patients with adenoid cystic carcinoma (ACC) had an ORR of 11.5% (3 of 26) and a median progression-free survival of 19.1 months. Conclusions: JNJ-64619178 demonstrated manageable dose-dependent toxicity and preliminary evidence of antitumor activity in ACC and other tumor types. Plasma exposure was dose dependent, and target inhibition was maintained with intermittent and continuous dosing. On the basis of safety, clinical activity, PK, and PD findings, two provisional RP2Ds were selected: 1.5 mg intermittently and 1.0 mg once daily. Aside from ACC, clinical benefit was limited, and biomarkers to enrich for responsiveness to PRMT5 inhibition will be needed for further development. /
Publisher: American Association for Cancer Research (AACR)
Date: 15-09-2023
Publisher: American Association for Cancer Research (AACR)
Date: 08-2023
DOI: 10.1158/1078-0432.23815998
Abstract: Supplementary Figure 1: Overall Response Over Time on JNJ-64619178 Treatment A. Dose Cohorts 0.5 mg - 1.5 mg (schedule A& B). B. Dose Cohorts 2.0 mg - 4.0 mg (schedule A& B)
Publisher: American Association for Cancer Research (AACR)
Date: 15-09-2023
Location: United States of America
Location: United States of America
No related grants have been discovered for Junchen Gu.