Top line data show that the randomized Phase II study of TG4001 in combination with avelumab versus avelumab in patients with recurrent or metastatic HPV16-positive cervical and anogenital tumors did not meet the primary objective of improvement in progression-free survival
Pre-planned subgroup analysis showed a positive efficacy trend in favor of the TG4001 containing regimen in patients with cervical cancer
Transgene will complete full analysis of the data before deciding on the best way forward for TG4001
Transgene will host a conference call today at 3:30 p.m. CET
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.
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