Amrubicin

Shows activity

Also known as:

Calsed SM-5887

Cancer types include:

small cell lung cancer

TrialFetch AI Analysis

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Overview

Amrubicin (Calsed; SM-5887) is a synthetic anthracycline chemotherapy drug studied primarily in small-cell lung cancer (SCLC). It has been approved for lung cancer in Japan; it is not simply a preclinical investigational drug. (pmc.ncbi.nlm.nih.gov)

Mechanism of action

Amrubicin and its active metabolite, amrubicinol, inhibit DNA topoisomerase II, an enzyme involved in managing DNA during replication. Their action stabilizes topoisomerase II–DNA cleavage complexes, causing DNA damage and cancer-cell death. (pmc.ncbi.nlm.nih.gov)

Efficacy

Previously treated SCLC: In a randomized phase III trial of 637 patients, amrubicin produced a response rate of 31.1%, versus 16.9% with topotecan. Median overall survival—the trial’s primary endpoint—was 7.5 versus 7.8 months, respectively; amrubicin did not significantly improve survival. (ascopubs.org)
First-line, extensive-stage SCLC: Results depended on the comparator. In a Chinese phase III trial, amrubicin plus cisplatin had a 69.8% response rate versus 57.3% with etoposide plus cisplatin; median survival was 11.8 versus 10.3 months, a difference that was not statistically significant. In a separate Japanese phase III trial, amrubicin plus cisplatin was inferior in survival to irinotecan plus cisplatin, despite similar response rates. (pubmed.ncbi.nlm.nih.gov)

Safety

Bone-marrow suppression and infection are important risks. In the second-line phase III trial, grade 3 or worse neutropenia occurred in 41% of amrubicin recipients, infections in 16%, and febrile neutropenia in 10%. In the Japanese first-line trial, amrubicin plus cisplatin caused more grade 3–4 febrile neutropenia than irinotecan plus cisplatin (32.1% versus 10.6%). (ascopubs.org)

Active trials using Amrubicin

Found 2 active trials using this drug:

A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 Versus Standard of Care in Subjects With Relapsed/Refractory Small Cell Lung Cancer (SCLC)

Sponsor: AbbVie (industry) Phase: 3 Start date: July 2, 2026

TrialFetch AI summary: Adults with relapsed or refractory SCLC after prior systemic therapy, generally including platinum-etoposide plus a checkpoint inhibitor when eligible and tarlatamab, are randomized to intravenous ABBV-706 or investigator-selected topotecan, lurbinectedin, or amrubicin. ABBV-706 is an investigational SEZ6-targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT07365241

A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd), a B7-H3 Antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice (TPC) in Subjects With Relapsed Small Cell Lung Cancer (SCLC) (IDeate-Lung02)

Sponsor: Daiichi Sankyo (industry) Phase: 3 Start date: May 21, 2024

TrialFetch AI summary: Adults with measurable relapsed extensive-stage SCLC after one platinum-based regimen and ECOG performance status 0–1 are randomized to ifinatamab deruxtecan or physician’s choice of topotecan, lurbinectedin, or amrubicin. Ifinatamab deruxtecan is an investigational B7-H3–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT06203210