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Ref Type Journal Article
PMID (28368437)
Authors Poveda A, Del Campo JM, Ray-Coquard I, Alexandre J, Provansal M, Guerra Alía EM, Casado A, Gonzalez-Martin A, Fernández C, Rodriguez I, Soto A, Kahatt C, Fernández Teruel C, Galmarini CM, Pérez de la Haza A, Bohan P, Berton-Rigaud D
Title Phase II randomized study of PM01183 versus topotecan in patients with platinum-resistant/refractory advanced ovarian cancer.
Journal Annals of oncology : official journal of the European Society for Medical Oncology
Vol 28
Issue 6
Date 2017 Jun 01
URL
Abstract Text PM01183 is a new compound that blocks active transcription, produces DNA breaks and apoptosis, and affects the inflammatory microenvironment. PM01183 showed strong antitumor activity in preclinical models of cisplatin-resistant epithelial ovarian cancer.Patients with platinum-resistant/refractory ovarian cancer were included in a two-stage, controlled, randomized (in a second stage), multicenter, phase II study. Primary endpoint was overall response rate (ORR) by RECIST and/or GCIG criteria. The exploratory first stage (n = 22) confirmed the activity of PM01183 as a single agent at 7.0 mg flat dose every 3 weeks (q3wk). The second stage (n = 59) was randomized and controlled with topotecan on days 1-5 q3wk or weekly (every 4 weeks, q4wk).ORR was 23% (95% CI, 13%-37%) for 52 PM01183-treated patients. Median duration of response was 4.6 months (95% CI, 2.5-6.9 months), and 23% (95% CI, 0%-51%) of responses lasted 6 months or more. Ten of the 12 confirmed responses were reported for 33 patients with platinum-resistant disease [ORR = 30% (95% CI, 16%-49%)]; for the 29 patients treated with topotecan in the second stage, no responses were found. Median PFS for all PM01183-treated patients was 4.0 months (95% CI, 2.7-5.6 months), and 5.0 months (95% CI, 2.7-6.9 months) for patients with platinum-resistant disease. Grade 3/4 neutropenia in 85% of patients; febrile neutropenia in 21% and fatigue (grade 3 in 35%) were the principal safety findings for PM01183.PM01183 is an active drug in platinum-resistant/refractory ovarian cancer and warrants further development. The highest activity was observed in platinum-resistant disease. Its safety profile indicates the dose should be adjusted to body surface area (mg/m2).EudraCT 2011-002172-16.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown fallopian tube cancer not applicable Lurbinectedin Phase II Actionable In a Phase II trial, Lurbinectedin (PM01183) treatment in patients with either ovarian, peritoneal, or fallopian tube cancer resulted in an overall response rate of 23% (12/52), which included one complete response and eleven partial responses, and a median duration of response of 4.6 months and 23% (12/52) of responses lasted for 6 months or more (PMID: 28368437). 28368437
Unknown unknown ovarian cancer not applicable Lurbinectedin Phase II Actionable In a Phase II trial, Lurbinectedin (PM01183) treatment resulted in an overall response rate of 23% (12/52) of patients with platinum-resistant or refractory ovarian cancer, with a median duration of response of 4.6 months (PMID: 28368437). 28368437
Unknown unknown peritoneum cancer not applicable Lurbinectedin Phase II Actionable In a Phase II trial, Lurbinectedin (PM01183) treatment in patients with either ovarian, peritoneal, or fallopian tube cancer resulted in an overall response rate of 23% (12/52), which included one complete response and eleven partial responses, and a median duration of response of 4.6 months and 23% (12/52) of responses lasted for 6 months or more (PMID: 28368437). 28368437