French biotechnology company Transgene (Euronext Paris:TNG) revealed on Monday that its randomised Phase II study evaluating TG4001 in combination with avelumab for recurrent or metastatic HPV16-positive cervical and anogenital tumours did not meet its primary objective of improving progression-free survival.
While the primary endpoint was not met, a pre-planned subgroup analysis showed a positive efficacy trend in favour of the TG4001-containing regimen in cervical cancer patients.
Transgene will now conduct a thorough analysis of the data to determine the optimal path forward for TG4001, in particular in cervical cancer.
Despite the primary objective not being met, the treatment was well-tolerated, with adverse events consistent with previous observations.
Transgene plans to present the complete study results at a future scientific conference.
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