Celldex’s Rintega Demonstrates Long-Term Survival

Celldex’s Therapeutics’ Rintega demonstrated 25 percent survival benefit versus 0 percent in the control arm for treatment of glioblastoma.

The company’s Phase 2 long-term survival study showed that at two years, nine of 10 patients with EGFRvIII-positive, recurrent glioblastoma remain alive on the Rintega (rindopepimut) arm compared with two of five patients on the control arm. The median time from recurrence to death for EGFRvIII-positive patients is 8.7 months.

The company previously reported that the therapeutic vaccine candidate met the primary response rate of progression-free survival at six months.

In addition, 30 percent of patients on the Rintega arm experienced a confirmed objective response rate compared with 18 percent on the control arm.

The study compared Rintega combined with Avastin (bevacizumab) to Avastin alone in patients with EGFRvIII-positive, recurrent glioblastoma.

Rintega is currently in Phase 3 studies; the FDA granted the EGFR inhibitor breakthrough therapy designation for adult patients with EGFRvIII-positive glioblastoma.