Celldex (CLDX) Reports Publication of Rindopepimut Phase 2 Data
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Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced the presentation of mature overall survival (OS) data for ACT III, a multi-center, single arm, Phase 2 clinical trial of rindopepimut (CDX-110) in patients with newly diagnosed EGFRvIII-positive glioblastoma (GB). The data showed a final median OS of 24.6 months from diagnosis, which is significantly better than 15.2 months for a historical cohort of patients selected to match ACT III eligibility criteria. The median OS data obtained from the 31 centers participating in the ACT III study are very consistent with two previous smaller studies with rindopepimut in GB (ACTIVATE and ACT II) conducted at M.D. Anderson and Duke University which showed 24.6 and 24.4 month median OS, respectively. These data were described in an oral presentation at the 16th Annual Meeting of The Society for Neuro-Oncology (SNO) in Orange County, CA by the lead investigator on the study, Dr. Rose Lai.
Sampson, et al. J Clin Oncol. 2010 Nov 1;28(31):4722-9.Historical controls were treated at M.D. Anderson and matched for eligibility (EGFRvIII-positive, KPS ≥ 80%, complete resection, radiation/TMZ and without progression through ~ 3 months post-diagnosis).+ Stupp, et al. N Engl J Med 2005;352:987-96.
Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor-specific oncogene, epidermal growth factor receptor variant III (EGFRvIII). The multi-center Phase 2 trial enrolled 65 patients with newly-diagnosed and optimally resected EGFRvIII-expressing GB. About 3 months post-diagnosis and following treatment with standard chemoradiation, patients started vaccination with rindopepimut in combination with standard of care (SoC) temozolomide therapy.
The results for the predefined primary endpoint (66% Progression Free Rate or “PFR” at approximately 8.5 months post-diagnosis) show a statistically significant improvement (p=0.0168, 95% CI) over a predetermined estimate of 53%, which was a high estimate derived from published results for standard chemoradiation with temozolomide (45%) and a cohort of patients with tumors expressing the EGFRvIII oncogene selected to match major ACT III eligibility criteria (29%).
Median OS was 24.6 months from diagnosis, which is significantly better than the matched EGFRvIII positive cohort (15.2 months). OS at 24 months was 52% compared with 6% for the matched EGFRvIII positive cohort. The apparent PFS and OS benefits were seen in both temozolomide sensitive (MGMT methylated) patients as well as temozolomide resistant (MGMT unmethylated) patients.
Robust, specific and durable anti-EGFRvIII immune responses were generated. The high level of immunity seen in vaccinated patients is again associated with loss of EGFRvIII at recurrence. Rindopepimut was generally well-tolerated with treatment duration up to more than 7 years; toxicities consisted chiefly of injection site reactions, while fatigue, rash, nausea and pruritus also occurred in >10% of patients. Activity and safety data are very consistent with previous smaller studies of rindopepimut in GB conducted at M.D. Anderson and Duke University (ACTIVATE and ACT II).
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Sampson, et al. J Clin Oncol. 2010 Nov 1;28(31):4722-9.Historical controls were treated at M.D. Anderson and matched for eligibility (EGFRvIII-positive, KPS ≥ 80%, complete resection, radiation/TMZ and without progression through ~ 3 months post-diagnosis).+ Stupp, et al. N Engl J Med 2005;352:987-96.
Rindopepimut is an investigational immunotherapeutic vaccine that targets the tumor-specific oncogene, epidermal growth factor receptor variant III (EGFRvIII). The multi-center Phase 2 trial enrolled 65 patients with newly-diagnosed and optimally resected EGFRvIII-expressing GB. About 3 months post-diagnosis and following treatment with standard chemoradiation, patients started vaccination with rindopepimut in combination with standard of care (SoC) temozolomide therapy.
The results for the predefined primary endpoint (66% Progression Free Rate or “PFR” at approximately 8.5 months post-diagnosis) show a statistically significant improvement (p=0.0168, 95% CI) over a predetermined estimate of 53%, which was a high estimate derived from published results for standard chemoradiation with temozolomide (45%) and a cohort of patients with tumors expressing the EGFRvIII oncogene selected to match major ACT III eligibility criteria (29%).
Median OS was 24.6 months from diagnosis, which is significantly better than the matched EGFRvIII positive cohort (15.2 months). OS at 24 months was 52% compared with 6% for the matched EGFRvIII positive cohort. The apparent PFS and OS benefits were seen in both temozolomide sensitive (MGMT methylated) patients as well as temozolomide resistant (MGMT unmethylated) patients.
Robust, specific and durable anti-EGFRvIII immune responses were generated. The high level of immunity seen in vaccinated patients is again associated with loss of EGFRvIII at recurrence. Rindopepimut was generally well-tolerated with treatment duration up to more than 7 years; toxicities consisted chiefly of injection site reactions, while fatigue, rash, nausea and pruritus also occurred in >10% of patients. Activity and safety data are very consistent with previous smaller studies of rindopepimut in GB conducted at M.D. Anderson and Duke University (ACTIVATE and ACT II).
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