Transgene cancer vaccine TG4001 trial misses main goal

Shares of French biotech Transgene (Euronext: TGN) tumbled 13.5% to 1.01 euros by late morning after it announced 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).

Transgene noted 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 arou nd half of the patients enrolled in the study.

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