OSE Immunotherapeutics has temporarily paused patient enrollment in a Phase 3 clinical trial evaluating Tedopi (OSE2101) for non-small cell lung cancer (NSCLC), following a recommendation by an Independent Data Monitoring Committee (IDMC).
The ATALANTE 1 Phase 3 study (NCT02654587) is evaluating the investigational Tedopi, a combination of 10 optimized neo-epitopes created to induce specific T-cell activation in immuno-oncology. Neo-epitopes are parts of proteins that are structurally altered in cancer cells and trigger strong immune responses.
The aim of the Phase 3 study is to determine if Tedopi is more effective than standard treatment with Taxotere (docetaxel) or Alimta (pemetrexed) in HLA-A2-positive patients with advanced NSCLC who are unsuitable to receive radiotherapy, and have received one or two prior lines of therapy.
The trial’s primary goal was to measure an improvement in overall survival time. Secondary outcome measures include progression-free survival, or the time to disease progression, objective response rate (the proportion of patients who achieve a partial or a complete response to treatment), and patient-reported outcomes.
Treatment safety profile was as expected and consistent with that seen in previous Tedopi clinical studies. So, patients who already were receiving treatment will continue to further assess the benefit/risk balance of this treatment, the company stated in a press release. Following additional review of patients’ data, a decision will be made for trial continuation as such, or for possible amendment to include specific sub-groups.
“The company has decided to halt temporarily patient enrollment, but to continue treatment of patients already enrolled in this clinical trial, due to an emerging benefit/risk balance of the experimental treatment,” Dominique Costantini, OSE’s chief executive officer, said in the press release. “Patients eligible for inclusion in the Atalante 1 study are cancer patients at an advanced stage who have failed a first-line treatment with chemotherapy or failed second-line therapy with checkpoint inhibitors, and enter the trial at stage of disease progression. This cancer progression may be difficult to control for some patients in the near-term due to the generally longer-term activity observed with a combination of neoepitopes, which differs from chemotherapy’s generally near-term activity,” Costantini said.
Tedopi has an orphan drug designation granted by the U.S. Food and Drug Administration to treat NSCLC in HLA-A2-positive patients.