OSE reports positive Phase 2 data, but questions remain
French biotech OSE Immunotherapeutics has reported higher one-year survival rates with two combinations of its cancer vaccine Tedopi compared with chemotherapy alone in a Phase 2 lung cancer trial. However, the results are similar to those previously achieved with Tedopi alone, raising questions about the added benefit of combination treatment.
Why it matters: Tedopi has already shown signs of activity in patients with advanced non-small cell lung cancer (NSCLC) who have exhausted standard treatments, but its clinical benefit remains uncertain. The latest results reinforce the vaccine’s potential without clearly demonstrating that combining it with chemotherapy or another immunotherapy provides additional efficacy.
By the numbers: The randomized, open-label Combi-TED trial enrolled 106 patients with metastatic NSCLC whose disease had progressed after first-line chemotherapy and immunotherapy. All patients carried the HLA-A2 genetic marker required for Tedopi treatment.
- One-year overall survival reached 47% with Tedopi plus docetaxel chemotherapy and 46% with Tedopi plus nivolumab (Opdivo), compared with 29% for docetaxel alone.
- OSE reported that both combinations met the study’s primary endpoint. However, the company has not disclosed conventional between-arm hazard ratios or confidence intervals. Its Bayesian analysis indicated a probability exceeding 90% that the combinations improved one-year survival compared with docetaxel alone.
Yes, but: Combi-TED did not include a Tedopi monotherapy arm, making it impossible to determine how much benefit, if any, came from adding docetaxel or nivolumab.
- The survival figures closely resemble those reported in OSE’s earlier Phase 3 ATALANTE-1 study. In a 2020 interim analysis, Tedopi alone achieved 46% one-year survival, compared with 36% for chemotherapy.
- The trial, which was terminated early during the COVID-19 pandemic, ultimately failed to demonstrate a statistically significant overall survival benefit in the full population of 219 patients.
- However, a subgroup of 118 patients who had developed secondary resistance to immunotherapy did benefit significantly, with median overall survival reaching 11.1 months on Tedopi versus 7.5 months on chemotherapy.
Between the lines: The nearly identical survival rates across the two trials raise questions about the added value of combining Tedopi with other treatments. However, differences in patient populations and prior treatment mean the results cannot be directly compared.
- The weaker performance of the Combi-TED control arm, with 29% one-year survival versus 36% in the earlier ATALANTE-1 analysis, also complicates the interpretation.
The big picture: Other trials illustrate the challenges in this setting. In Gilead Sciences’ Phase 3 EVOKE-01 study, the antibody-drug conjugate sacituzumab govitecan achieved 46.6% one-year survival versus 36.7% for docetaxel, but failed to demonstrate a statistically significant overall survival benefit.
What’s next: OSE is continuing development of Tedopi alone in the Phase 3 ARTEMIA trial, which is recruiting NSCLC patients with secondary resistance to immunotherapy. Results are expected in early 2028.
- Detailed Combi-TED results will be presented at the European Society for Medical Oncology congress on October 25. Those findings should help clarify the strength of the survival signal.
