Transgene’s cancer vaccine trial shows mixed results

Phase 2 study of TG4001 shows promise in cervical cancer patients

Transgene, a biotech company specializing in virus-based immunotherapies for cancer, has announced that its phase 2 trial of TG4001 in combination with avelumab did not meet its primary objective of improving progression-free survival in patients with recurrent or metastatic HPV16-positive cervical and anogenital cancers.

Despite this setback, a pre-planned subgroup analysis revealed a positive efficacy trend in favor of the TG4001 regimen among cervical cancer patients.

This subgroup, which makes up about half of the study’s participants, showed promising results that warrant further investigation, particularly in relation to PD-L1 status.

Dr Alessandro Riva, Chairman and CEO of Transgene, commented: “Failure to meet the primary objective in our Phase II study with TG4001 is disappointing. Nevertheless, we are encouraged by the positive efficacy trend in favor of the combination regimen in cervical cancer patients. We plan to complete a full and rigorous analysis of the data before deciding on any path forward for this asset, in particular in cervical cancer, in the context of the evolving treatment landscape.”

The treatment was well tolerated, with adverse events consistent with previous observations. Transgene is currently conducting a detailed evaluation of the full study results and will provide further updates once this analysis is complete.

Dr Riva added: “The complete study results will be presented at an upcoming scientific conference. We would like to thank all the patients and caregivers who have taken part in this study for their important contribution.”

Transgene remains focused on advancing its lead asset, TG4050, an individualized cancer vaccine for head and neck cancers, with additional data expected in November 2024.