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Transgene reports clinical results of TG4001 plus avelumab

Transgene SA has reported positive results of an exploratory Phase Ib/II study in HPV-16-positive cancers combining its cancer vaccine TG4001 with Merck KgaA’s PD-L1 blocker avelumab.

Combination of TG4001 and Merck KGaA’s checkpoint inhibitor avelumab demonstrated anti-tumour activity in patients with previously treated recurrent and/or metastatic HPV16-positive cancers. While the treatment combo proved save in 34 evaluable patients with no new safety signals, the outcome was highly dependent from the absence of liver metastases.

Overall, Transgene observed an overall response of 23.5% in the study (NCT03260023). In the 23 patients without metastases who progressed tdespite one or two lines of chemotherapy, Transgene observed an ORR of 34.8% with 8 complete responses and a median progression-free survival (PFS) of 5.6 months. In the 11 patients with liver metastasis PFS was reduced to 1.4 months.
TG4001 is a HPV16-targeted MVA-based therapeutic vaccine that targets the viral E6 and E7 antigens with interleukin 2 (OL-2) as an adjuvant. Co-administration of TG4001 and Merck’s PD-L1 blocker avelumab induced HPV-specific T-cell responses and was associated with increased levels of immune cell infiltration in the tumours and expression of genes associated with activation of the immune system. Transgene speculated that TG4001 was able to induce a tumour-specific immune response and thus might overcome immunosuppression in the tumour microenvironment. The results, however, warrant further confirmation in a larger controlled randomized study, the company said.  The results compare favorably to current standards of care and single-agent immune checkpoint inhibitors.

“The observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response. Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” commented Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.