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Lurbinectedin (PM01183), an active compound in platinum-resistant/refractory ovarian cancer (PRROC) patients: Results of a two-stage, controlled phase II study.
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: PM01183 is a new anticancer agent that blocks the trans-activated transcription and induces the formation of double-strand breaks in a wide range of cancer cell lines, including platinum-resistant (Pt-res). Methods: PRROC patients (pts) with less than 3 prior chemotherapy (CT) containing lines, adequate organ function and performance status (PS) 0-2 were included. The primary endpoint was overall response rate (ORR) (by RECIST v1.1 and/or Rustin criteria). Secondary endpoints were progression free survival (PFS), overall survival (OS) and safety. Pts were treated with i.v. PM01183 (P1), 7 mg flat dose, q3wk in the first stage. In the second stage, pts were randomized (1:1) to PM01183 (P2) or topotecan (T) (standard or weekly regimen). Cross-over to the P2 arm was allowed after progression to T. Results: 81 pts were included (P1/P2/T: 22/30/29). Global median characteristics of pts were balanced: age 61 years; PS 1; Pt-res (P1/P2/T: 16/17/16 pts); prior bevacizumab: 18.5% of pts, median prior advanced chemotherapy lines: 1 in each arm. Efficacy results are summarized in the Table. The most common PM01183 related AEs were neutropenia (Gr 3-4, 85%), febrile neutropenia (23%), thrombocytopenia (Gr 3-4, 29%), nausea/vomiting (Gr 3, 16%) and fatigue (Gr 3, 37%) Conclusions: PM01183 is an active drug in Pt-res/Pt-ref ovarian cancer. The study has met the primary endpoint, showing statistically significant superiority over T in terms of ORR, PFS and OS. The safety profile is predictable and manageable; prophylactic G CSF is recommended. A phase III study in Pt-res ovarian cancer is planned.
|OR [n (%)]|
|CR||0 (0)||1 (3)||0 (0)||-|
|PR||§6 (27)||4 (14)||0 (0)|
|SD||12 (55)||13 (45)||15 (52)|
|PD||4 (18)||10 (34)||14 (48)|
|Treatment failure||0 (0)||1 (3)||0 (0)|
|ORR (%) (95% CI)||22 (11-35)||-||0.006|
|PFS (months) *||3.9||2.0||0.003|
|OS (months) +||10.6||5.7||0.029|
Abbreviations: Pt-ref, platinum-refractory; DCR, disease control rate. §2 PRs by Rustin criteria, *events: 81%; +events: 64%.
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