Acceptance of Late Breaking Abstract at Upcoming SITC 2020 Conference, on the detailed results from clinical study of TG4001 in combination with avelumab in advanced HPV-positive cancers

Acceptance of Late Breaking Abstract at Upcoming SITC 2020 Conference, on the detailed results from clinical study of TG4001 in combination with avelumab
in advanced HPV-positive cancers

Strasbourg, France, October 19, 2020, 7:30 a.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, announced that detailed results of the data from the Phase 1b/2 trial combining TG4001, a HPV16 targeted therapeutic vaccine, with avelumab (BAVENCIO®), a human anti-PD-L1 antibody, in HPV16-positive recurrent and/or metastatic malignancies, will be presented in a poster presentation at the upcoming virtual meeting of the Society for Immunotherapy of Cancer (SITC) taking place November 9-14, 2020.

The principal investigator Professor Christophe Le Tourneau will present results from a pooled analysis of the Phase 1b/2 trial, including response rate, median progression-free survival, as well as the impact of patient/disease characteristics on outcome and immunogenicity.

As a reminder, the analysis of the trial data demonstrated clinical activity of the combination regimen and confirmed a manageable safety profile.

The purpose of this exploratory Phase 1b/2 trial was to evaluate the safety and efficacy of the combination of TG4001 and an immune checkpoint inhibitor in a heterogeneous group of patients with aggressive, recurrent and/or metastatic HPV16-positive cancer. Clinical activity was observed in the overall study population (34 evaluable patients with oropharyngeal, anal, cervical, or other HPV16-positive cancers).

In addition, Transgene has identified patient characteristics associated with promising clinical activity in this trial. For more than 50% of these patients, the disease had not progressed at 12 weeks, compared to an expected median progression-free survival (PFS) of 8 weeks for this population with current treatment regimens [*]. Consistent with data presented at ESMO 2019 ^[1], durable responses have been observed in most of the responder patients.

The trial was being conducted in collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer. 

About the trial

This multi-center, open-label trial is assessing the safety and efficacy of this immunotherapy combination regimen (TG4001 + avelumab) in patients with HPV16-positive cancers who have disease progression after at least one line of systemic treatment for recurrent/metastatic disease (NCT03260023). Prof. Christophe Le Tourneau, M.D., PhD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, and a world expert in drug development and head and neck cancers, is the Principal Investigator of the study. The trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company, which in the US and Canada operates its biopharmaceutical business as EMD Serono, and Pfizer Inc. (NYSE: PFE).

Patients received TG4001 at the dose of 5x10⁷ pfu, SC, weekly for 6 weeks, every 2 weeks up to six months, and every 12 weeks thereafter, in combination with avelumab at 10 mg/kg, IV every two weeks, until disease progression.

The primary endpoint of the Phase 2 part is the overall response rate (ORR, using RECIST 1.1). Secondary endpoints include progression-free survival, overall survival, disease control rate and other immunological parameters. 

More information on the trial is available on clinicaltrials.gov.

***

Contacts

[*] Current treatment regimens, including immune checkpoint inhibitors, for patients with metastatic disease receiving a second (or further) line of treatment for their HPV16 associated indications deliver very limited benefit. With immune checkpoint inhibitors, overall response rates are around 10–15% ^[2-6] in this heterogenous group of malignancies, while median overall survival is less than 11 months ^[2-6] and median progression-free survival is around 2 months ^[2-6].