A Phase 3 trial assessing the ability of Tedopi to treat people with advanced non-small cell lung cancer (NSCLC) who failed to respond to prior therapy can again enroll patients — but only those who showed no benefit from treatment with PD-1/PD-L1 immune checkpoint inhibitors, OSE Immunotherapeutics reported.
Under a revised protocol for the trial agreed to by the independent boards overseeing the trial, NSCLC patients who had a poor response to prior chemotherapy will no longer be recruited.
Patient enrollment was temporarily paused in June 2017 on the recommendation of the independent and expert boards, and attributed to a need to evaluate data regarding Tedopi’s benefits against its risks in these two groups of pre-treated patients. Those already enrolled continued receiving treatment while the review was underway.
No new or unexpected safety concerns were seen in either group of patients, the company said at the time.
ATALANTE 1, as the open-label Phase 3 trial (NCT02654587) taking place across the U.S. and Europe is called, began recruiting lung cancer patients in February 2016. All are at an advanced stage (invasive 3b or metastatic 4), and they initially showed no benefit to either a first-line treatment with chemotherapy or a second-line treatment with immune checkpoint inhibitors.
Enrollment will now focus exclusively on those who failed to respond to one or two previous treatments with the checkpoint inhibitors. Recruitment will reopen at U.S. sites first, OSE Immunotherapeutics, which is based in France, said.
“We are pleased to resume recruitment in this Tedopi Phase 3 study, with a design that addresses the treatment needs of a specific patient population, for whom there is currently no approved therapeutic option,” Dominique Costantini, company CEO, said in a press release. “We warmly thank all of the clinical investigators participating in this clinical trial for their continued support.”
ATALANTE 1 aims to determine if Tedopi is more effective at extending overall survival than standard chemotherapy — Taxotere (docetaxel) or Alimta (pemetrexed) — in advanced NSCLC patients.
The trial consists of two parts. First, survival data in about 100 treated patients (an open-label trial has no untreated or placebo group) will be analyzed for clinical benefits, with results expected in about two years. Findings from that analysis will help to establish the study’s second part.
Overall survival at two years is the study’s main endpoint; secondary goals include progression-free survival and quality of life.
OSE is also planning a Phase 2 trial of Tedopi as maintenance therapy for advanced pancreatic cancer in collaboration with the French oncology physician network GERCOR.
Tedopi is a cancer vaccine based on a combination of 10 small proteins (epitopes) optimized to recognize five cancer biomarkers (tumor proteins). It intends to improve the immune system’s ability to recognize and eliminate cancer cells.
The vaccine was designated an orphan drug by the U.S. Food and Drug Administration (FDA), and has personalized medicine status in Europe for HLA-A2 positive NSCLC patients.