Date: 2011-05-17
Type of information:
phase: 2
Announcement: results
Company: Teva Pharmaceutical Industries (Israel) CureTech (Israel)
Product: CT-011
Action mechanism: PD-1 appears on tumor-reactive lymphocytes and induces apoptosis of these cells. CT-011 blocks PD-1, a "programmed death' receptor, and revitalizes the body's own immune system.
Disease: Diffuse Large B Cell Lymphoma
Therapeutic area: Cancer - Oncology
Country: USA, Asia, South America, Israel
Trial details: Seventy two patients in 30 centers in the US, Asia, South America and Israel, entered the study 1-3 months after ASCT. Patients received up to 3 injections of CT-011 every 6 weeks and were then followed for 13 months without further treatment. The historical comparator for this study was a cohort of 198 patients who had participated in the DHAP arm of the CORAL (ASCO, 2009) study (the historical control). In addition to the clinical endpoints, about 100 biomarkers were also monitored at different time points.
Latest
news: Teva Pharmaceutical Industries and CureTech have announced preliminary topline results for CT-011, an investigational anti-PD-1 monoclonal antibody. CT-011 met the primary endpoint of improved progression-free survival (PFS), in a Phase II clinical trial in patients with Diffuse Large B Cell Lymphoma (DLBCL) following autologous stem cell transplantation. Statistically significant results have also been achieved in the secondary endpoint of Overall Survival (OS).
Preliminary analyses indicate that 70% of the patients treated with CT-011 were progression-free at the end of the follow-up period, as compared to only 47% in the historical control. Furthermore, 84% of the patients treated with CT-011 were alive by the end of the follow-up period, compared to only 62% in the historical control. Final Phase II results for CT-011 in DLBCL are expected to be available during the third quarter of this year. These data will be presented at future international scientific meetings.
The results also indicate an increase in the number of specific T cells responsible to the maintenance of long-term immunologic memory. This may explain the long term effect of the treatment shown in the study.
