Transgene announces phase II trial of therapeutic cancer vaccine TG 4001 in recurrent or metastatic HPV16-positive cervical and anogenital cancers did not meet the primary objective of improvement in progression-free survival
Transgene announces that its randomized Phase II study to evaluate TG 4001 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 TG 4001 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.
TG 4001 was evaluated in a multi-center, open label, randomized Phase II trial (NCT03260023) designed to compare the efficacy of the combination of TG 4001 and avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive cervical and anogenital cancers who have disease progression after a maximum of one line of systemic treatment, or who are not eligible for first-line chemotherapy. The overall trial enrolled 100 patients.
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