Clinical Trials

* On December 4, 2014, Zeltia announced that its pharmaceutical division PharmaMar has data from a group of 33 randomized patients with platinum-resistant ovarian cancer demonstrating that PM1183 shows a significantly superior median overall survival compared to topotecan. In this multicenter Phase IIb randomized trial, platinum-resistant ovarian patients treated with PM1183 lived longer, with a median overall survival of 18.1 months, compared to topotecan, which only achieves 8.5 months. PharmaMar will launch a pivotal Phase III trial to confirm the efficacy of PM1183 in a larger population, and that is expected to be the final step before registration of PM1183 for platinum-resistant ovarian cancer. Results presented at the American Society of Clinical Oncology (ASCO) earlier this year showed a significant improvement in the other secondary endpoint, progression-free survival, as well as in the overall response rate, which was the primary endpoint (see below). The results found now for the overall survival of patients with platinum-resistant ovarian cancer treated with PM1183 add to the clinical benefit, measured as 70% of overall responses and stable disease, previously observed. The manageable safety profile previously described for these patients has not changed.

* On June 2, 2014, Zeltia announced that its oncology subsidiary, PharmaMar, reported positive results in an oral presentation at the Annual Meeting of the American Society of Clinical Oncology 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 was designed in two stages. 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. 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.

* On September 12, 2013, Zeltia has announced that its oncology subsidiary, PharmaMar, reported results of a multicenter, open-label Phase II trial of PM01183 in patients with platinum resistant/refractory ovarian cancer. Results for the first stage of the trial were presented at the European Society for Medical Oncology (ECCO-ESMO-ESTRO) Congress in 2012. In the second stage of the trial, patients were treated with either PM01183 or topotecan. The primary endpoint was overall response rate (sum of complete responses plus partial responses). Progression free survival and overall survival were secondary endpoints in this study. Thirty percent (30.3%) of platinum resistant patients had an objective response to treatment with PM01183, while no patients in the topotecan arm responded. Clinical benefit (sum of objective responses plus stable diseases) was observed in 82% of patients treated with PM01183 and in 50% of patients in the topotecan arm. Median progression-free survival in resistant patients was 4.8 months for PM01183 and 1.7 months with topotecan (p=0.0004). Survival data is not yet mature, but a significant increase in overall survival can be observed in patients treated with PM01183 compared to topotecan. Neutropenia was the most common adverse event in both treatment arms and unexpected toxicity was not observed with PM01183. Detailed results will be presented at the upcoming European Cancer Congress (ECCO-ESMO-ESTRO) that will take place in Amsterdam from September 27th to October 1st this year.

PharmaMar is now designing a pivotal phase III study for PM01183 in platinum resistant ovarian cancer patients, which will be submitted to the appropriate regulatory authorities.

* On May 7, 2013, Zeltia has announced that its subsidiary PharmaMar has completed enrolment for the randomised Phase IIb trial in resistant/refractory ovarian cancer with PM01183 versus Topotecan. This open-label trial is designed to confirm PM01183's activity in this indication. The results of this Phase IIb trial will be presented at a major medical conference in 2013.