Zeltia today announced that its oncology subsidiary, PharmaMar, reported positive results in an oral presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in a paper entitled “Lurbinectedin (PM1183), PFS and OS results in a phase II study in platinum-resistant/refractory ovarian cancer (PRROC) patients”.
In this multicentre Phase II trial, patients with PRROC received PM1183 monotherapy, compared with treatment using topotecan.
This open Phase II trial, which was conducted in 9 hospitals in the European Union, was designed in two stages. In the first stage, 22 patients were treated with 7 mg infusion of PM1183 for one hour every three weeks. In the second stage, 58 evaluable patients were randomised with either PM1183 or topotecan. The results of the first stage were presented at the European Cancer Congress in 2012 and the final results of the trial were presented at ASCO. The primary endpoint was to evaluate the overall response rate in patients treated with PM1183 (this includes the sum of complete and partial responses). Secondary endpoints were progression free and overall survival.
PRROC patients treated with topotecan did not register any objective responses, whereas 30% of patients treated with PM1183 exhibited an objective response. Clinical benefit (objective response or disease stabilisation) was observed in 71% of patients treated with PM1183 and in 52% of those who were administered topotecan.
Median progression free survival in randomised PRROC patients treated with PM1183 was 5.7 months, compared with 1.7 months in patients treated with topotecan (p=0.0005).A statistically significant difference (p=0.039) of over four months was observed in overall survival between randomised patients treated with PM1183 and those in the control arm. That difference may prove to be even higher because more than 50% of the patients treated with PM1183 are still being monitored for survival.
During the trial, PM1183 evidenced a predictable and manageable safety profile.
Following the positive results obtained in this trial, PharmaMar is planning a pivotal Phase III trial with PM1183 for this indication.
About ASCO
The ASCO Annual Meeting, one of the world's main events in clinical cancer research, brings together over 30,000 oncology professionals to discuss the latest developments in this therapeutic area. For more information, visit www.asco.org
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