Transgene Provides Update on Phase II Trial of Therapeutic Cancer Vaccine TG4001 in Recurrent or Metastatic HPV16-Positive Cervical and Anogenital Cancers

Strasbourg, France, October 14, 2024, 7:30 a.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, announces that its randomized Phase II study to evaluate TG4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital tumors has not met the primary objective of the study (improvement in progression-free survival).

The pre-planned subgroup analysis showed a positive efficacy trend in favor of the TG4001 containing regimen in cervical cancer patients, which requires further confirmation through additional analyses, including by PD-L1 status. These patients account for approximately half of the patients enrolled in the study.

The treatment has been well tolerated. Adverse events are consistent with previous observations.

Transgene is currently evaluating the full study results in detail to determine the best way forward for this program and will communicate further once this is completed. 

Dr. Alessandro Riva, Chairman and CEO of Transgene, said: “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 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. With a diversified portfolio of novel immunotherapies targeting solid tumors, our strategy remains focused on advancing our lead asset, TG4050, an individualized cancer vaccine for head and neck cancers for use following surgery and adjuvant therapy. We expect to report additional data on TG4050 from the 24-month median follow-up of Phase I patients in our head and neck cancer trial in November 2024 at the SITC conference.”