LZM-005 / Livzon Pharma - LARVOL DELTA

Phase I study of LZM005 in patients with HER2-positive metastatic breast cancer. (PubMed, NPJ Breast Cancer) - "Here we report a phase I study that evaluated the safety, activity, and biomarkers of LZM005, a HER2 antibody, used as a monotherapy or in combination with trastuzumab plus docetaxel in patients with HER2-positive MBC. Biomarker analysis showed that chromatin remodeling genes KMT2B and BRWD1 were associated with better progression-free survival. LZM005 is well tolerated and shows potent activity in patients with HER2-positive MBC."

Journal • Metastases • P1 data • Breast Cancer • Dermatology • Dyslipidemia • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hypertriglyceridemia • Leukopenia • Neutropenia • Oncology • Pruritus • Solid Tumor • HER-2

Phase I study of LZM005 in patients with HER2-positive metastatic breast cancer (Nature) - P1a | N=34 | "In the phase Ia study, one patient achieved PR (20 mg/kg), six showed stable disease (SD), and seven showed progressive disease (PD). The ORR was 7.1%, and the DCR was 42.9%. Median PFS was 1.37 months (95% CI, 1.31 to 1.47 months). Median OS was 10.73 months (95% CI, 9.37 to 12.09 months). Among the six patients with SD, five continued to show SD for more than 12 weeks. The median duration of SD was 4.07 months (95% CI, 3.43 to 4.71 months). For the patient with PR, the duration of response was 2.83 months. At the time of data cutoff (December 31, 2020), all patients showed disease progression....In the phase Ib study, 11 patients (55.0%) achieved PR, eight (40.0%) had SD, and one showed PD. The ORR was 100% (6/6) in trastuzumab-naïve patients and 35.7% (5/14) in trastuzumab-pretreated patients. DCR was 92.9% (13/14) in trastuzumab-pretreated patients. The ORR and DCR were respectively 70.0% and 100% for the 420 mg arm, and 40.0% and 90.0% for the 525 mg arm."

P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology

[VIRTUAL] Phase I study of LZM005, a HER2 antibody, as monotherapy or in combination with trastuzumab and docetaxel in patients with HER2-positive metastatic breast cancer. (ASCO 2021) - "The pharmacokinetics of LZM005 were similar to pertuzumab (Table) . LZM005 was well tolerated and showed potent activity in patients with HER2-positive metastatic breast cancer . Further evaluation was warranted."

Clinical • Combination therapy • Monotherapy • P1 data • Anemia • Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Infectious Disease • Nephrology • Oncology • Solid Tumor