Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers

Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers

• Based on promising progression-free survival (PFS) interim analysis, trial to continue and an optimized number of patients to be randomized in the trial   
• Management to host webcast presentation of the interim results today, November 2, 2022 at 6 p.m. CET / 1 p.m. EST 

Strasbourg, France, November 2, 2022, 5:45 pm CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, today announces that following an interim analysis of its randomized controlled Phase II clinical study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV16-positive anogenital tumors (NCT: 03260023), the Independent Data Monitoring Committee (IDMC) has recommended the study continue.  Based on positive signals observed in the interim analysis, the trial is now expected to enroll an additional 66 patients, for a total trial size of 120 patients compared to the previously announced target of 150 patients. Transgene anticipates the last patient to be randomized in the trial in H1 2024.   

Hedi Ben Brahim, CEO, and Dr. Maud Brandely, Chief Medical Officer, MD, PhD, will host an analyst and investor call to discuss the interim analysis at 6:00 pm CET (1:00 pm EST) today (see details below).  

The Phase II study is evaluating TG4001, an investigational therapeutic cancer vaccine, in combination with avelumab compared to avelumab alone in patients with HPV16-positive anogenital tumors without liver metastases, through a continuing collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab.  

“We are very pleased with the outcome of this interim analysis,” said Hedi Ben Brahim, Chief Executive Officer of Transgene. “The IDMC’s recommendation to continue the study reinforces our confidence in TG4001, which follows promising data from our earlier Phase Ib/II trial. This also enables us to reduce the number of patients randomized in the trial. We are looking forward to completing this trial in H1 2024 and communicating its results when they are available. We expect that positive final results from this trial will allow us to launch a registration trial to further confirm the benefit of our therapeutic vaccine candidate. TG4001 aims to provide a new solution to patients who currently have very limited treatment options.” 

The interim analysis was triggered per protocol, by a predefined number of PFS events. Based on the interim results, the IDMC’s objective was to provide a recommendation on the continuation of the trial and on the final sample size using adaptive sample size re-estimation modeling approach. 

To date, the treatment has been well tolerated. Adverse events are consistent with previous observations made in the Phase Ib/II trial. 

TG4001 is based on a MVA (Modified Vaccinia Ankara) vector, which is engineered to express HPV16 antigens (E6 & E7) and interleukin 2 (IL-2). TG4001 is designed to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens that can be found in HPV16-related tumors and to induce a specific cellular immune response against these cancer cells.  

Phase II trial aims to show superiority of TG4001 + avelumab over avelumab monotherapy  

The trial is enrolling patients in the USA and in Europe (France and Spain). It focuses on patients with recurrent or metastatic HPV16-positive anogenital cancer without liver metastases, including cervical, vulvar, vaginal, penile, and anal cancer. Patients are randomized to either receive the combination regimen of the therapeutic vaccine TG4001 and avelumab or avelumab alone.  

The primary endpoint of the trial is progression-free survival (PFS) according to RECIST 1.1. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS) and a series of immunological parameters.