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Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study

by Miller, Kathy D , LoRusso, Patricia , Adiwijaya, Bambang S , Hendriks, Bart S , Siegel, Barry A , Wickham, Thomas J , Munster, Pamela , Campbell, Karen , Shields, Anthony F , Reynolds, Joseph , Ma, Cynthia , Krop, Ian E , Molnár, István , Geretti, Elena , Moyo, Victor

in Anthracycline / Breast cancer / Cyclophosphamide / Doxorubicin / ErbB-2 protein / Fatigue / Metastases / Monoclonal antibodies / Mucosa / Nausea / Neuroimaging / Neutropenia / Pharmacokinetics / Targeted cancer therapy / Thrombocytopenia / Trastuzumab / Tumors

2018

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Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study

2018

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Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study

2018

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Journal Article

Safety and pharmacokinetics of MM-302, a HER2-targeted antibody–liposomal doxorubicin conjugate, in patients with advanced HER2-positive breast cancer: a phase 1 dose-escalation study

Miller, Kathy D,

LoRusso, Patricia,

Adiwijaya, Bambang S,

Hendriks, Bart S,

Siegel, Barry A,

Wickham, Thomas J,

Munster, Pamela,

Campbell, Karen,

Shields, Anthony F,

Reynolds, Joseph,

Ma, Cynthia,

Krop, Ian E,

Molnár, István,

Geretti, Elena,

Moyo, Victor

2018

Overview

BackgroundThis phase 1 dose-escalation trial studied MM-302, a novel HER2-targeted PEGylated antibody–liposomal doxorubicin conjugate, in HER2-positive locally advanced/metastatic breast cancer.MethodsPatients were enrolled in four cohorts: MM-302 monotherapy (8, 16, 30, 40, and 50 mg/m2 every 4 weeks [q4w]); MM-302 (30 or 40 mg/m2 q4w) plus trastuzumab (4 mg/kg q2w); MM-302 (30 mg/m2) plus trastuzumab (6 mg/kg) q3w; MM-302 (30 mg/m2) plus trastuzumab (6 mg/kg) and cyclophosphamide (450 mg/m2) q3w.ResultsSixty-nine patients were treated. The most common adverse events (AEs) were fatigue and nausea. Grade 3/4 AEs of special interest included neutropenia, fatigue, mucosal inflammation, anemia, thrombocytopenia, febrile neutropenia, and palmar-plantar erythrodysesthesia. The MTD was not reached. With MM-302 ≥ 30 mg/m2, overall response rate (ORR) was 13% and median progression-free survival (mPFS) 7.4 months (95% CI: 3·5–10·9) in all arms. In 25 anthracycline-naïve patients, ORR was 28·0% and mPFS 10·9 months (95% CI: 1·8–15·3). Imaging with 64Cu-labeled MM-302 visualized tumor-drug penetrance in tumors throughout the body, including the brain.ConclusionMM-302 monotherapy, in combination with trastuzumab, or trastuzumab plus cyclophosphamide, was well tolerated and showed promising efficacy. The selected phase 2 MM-302 dose was 30 mg/m2 plus 6 mg/kg trastuzumab q3w.

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Publisher

Nature Publishing Group

Subject

/ Fatigue