Positive Phase 3 Data Demonstrate NSCLC Vaccine’s Efficacy
Tedopi® safely improved overall survival and quality of life in patients with hard-to-treat non-small cell lung cancer
NANTES, FRANCE — OSE Immunotherapeutics recently announced the peer-reviewed publication of the findings of the randomized Phase 3 clinical trial (ATALANTE-1) on T-cell epitope cancer vaccine Tedopi® in HLA-A2-positive patients with advanced or metastatic non-small cell lung cancer (NSCLC) in monotherapy in third-line NSCLC with secondary resistance to immune checkpoint inhibitors (ICI).
Tedopi® is a novel T-cell epitope-based cancer vaccine targeting five tumor-associated antigens. It’s an activating and differentiated off-the-shelf immunotherapy expanding tumor-specific T cells in HLA-A2 cancer patients. The published paper features positive data from the randomized international Phase 3 study showing that the Tedopi® safely improves overall survival and quality of life profile in monotherapy compared to chemotherapy in HLA-A2 positive patients with advanced or metastatic NSCLC, who have progressed at least 12 weeks after sequential treatment with chemotherapy and immune checkpoint inhibitors (ICI).
Benjamin Besse, MD, PhD, professor, director of clinical research at Gustave Roussy Institute (IGR, Villejuif, France), and principal investigator of the ATALANTE-1 clinical trial, said, “Tedopi® is the first cancer vaccine to demonstrate positive results on survival in a randomized Phase 3 trial in advanced and metastatic NSCLC cancer patients in 3rd line. A significant reduction of the risk of death by 41 percent was achieved with a better safety profile and a maintained quality of life. This study, conducted in patients with secondary resistance to immunotherapy, compared Tedopi® monotherapy with standard-of-care docetaxel or pemetrexed chemotherapies. Further evaluation is clearly warranted in a second line of treatment of advanced and metastatic NSCLC, to potentially make this cancer vaccine available to hard-to-treat patients in failure and with high medical needs.”
Findings of the ATALANTE-1 trial
The Phase 3 clinical trial has demonstrated a significant therapeutic benefit in patients with secondary resistance to immune checkpoint inhibitors (ICI) defined as patients with failure to platinum-based chemotherapy followed by a minimum of 12 weeks ICI treatment (main analysis of the trial). Tedopi® demonstrated a favorable benefit/risk ratio versus standard of care (SoC) docetaxel or pemetrexed in advanced HLA-A2-positive NSCLC patients with secondary resistance to ICI. The main results were:
Improved efficacy
Overall survival (primary endpoint) was statistically significantly improved for Tedopi®, reduced the risk of death by 41 percent.
Postprogression survival was also significantly longer in the Tedopi® arm (7.7 months versus 4.6 months; p=0.004, HR=0.46).
Improved safety profile and quality of Life
The Eastern Cooperative Oncology Group (ECOG) score is a performance scale used to quantify the general health condition of a patient. It is subdivided into five grades from zero to five, ranging from fully active (0) to fully disabled, then to death (5).
Performance status of maintained general health condition with time to ECOG deterioration was significantly longer in the Tedopi® arm (9.0 months versus 3.3 months; p=0.006; HR=0.43).
A better quality of life was observed with Tedopi® (p= 0.04).
A good tolerance profile of Tedopi® with fewer Severe Adverse Events grade 3–5 (38 percent vs SoC 68 percent, p<0.001). No Treatment Emergent Adverse Effects (TEAE) of concern in the Tedopi® arm.
- This press release was originally published on the OSE Immunotherapeutics website