June 1, 2014 // .
Use of PM01183 resulted in superior efficacy compared with topotecan with regards to ORR, PFS and OS in patients with platinum-resistant ovarian cancer, according to data presented at the ASCO Annual Meeting.
“The treatment of patients with platinum-resistant ovarian cancer is a challenge and an unmet medical need,” Andres Poveda, MD, of the department of medical oncology at the Instituto Valenciano de Oncologia in Spain, said during a presentation here. “These patients require treatment that can overcome resistance.”
Andres Poveda
PM01183 (Lurbinectedin, PharmaMar) hinders trans-activated transcription and generates the formation of double-strand breaks in platinum-resistant cancer, as well as a wide range of other cancer lines, according to the study abstract.Patients with fewer than three prior chemotherapy cycles containing lines, who had satisfactory organ function and a performance status between zero and two were assigned 7-mg flat-dose PM01183, every 3 weeks during phase 1 (n=22). For the second phase, patients were randomly assigned in a 1:1 fashion to PM01183 (n=30) or topotecan (Hycamtin, GlaxoSmithKline; n=29). Patients whom progressed on topotecan were then able to advance to treatment with PM01183.
According to study results, the ORR of PM01183 — the primary endpoint, along with safety —was 21% (95% CI, 11-35). Overall PFS was 3.9 months with PM01183 vs. 2 months with topotecan (P=.003). Overall OS was 10.6 months with PM01183 compared with 5.7 months with topotecan (P=.039).
Common grade 3-4 adverse events associated with use of PM01183 included neutropenia (85%), febrile neutropenia (23%), thrombocytopenia (29%), nausea/vomiting (16%) and fatigue (37%).
“PM01183 is active in platinum-resistant refractory ovarian cancer. A phase 3 trial in these patients is underway,” Poveda said.