BioNTech and OncoC4 have treated the first subject in the Phase III PRESERVE-003 clinical trial of their BNT316/ONC-392 (gotistobart) for non-small cell lung cancer (NSCLC).

The open-label, two-stage, randomised trial will evaluate the safety and efficacy of the antibody as a single agent versus the standard-of-care chemotherapy (docetaxel).

It will enrol 600 metastatic NSCLC patients, who have cancer that advanced under prior therapy with PD-(L)1-inhibitor.

Trial subjects will be enrolled at sites in Europe, the US, Germany, Italy, Belgium and Spain.

Overall survival is the primary endpoint of the trial while progression-free survival, adverse event profile and overall response rate will be evaluated as secondary endpoints.

The trial commencement is based on positive findings from a Phase I/II study that analysed the safety and efficacy of BNT316/ONC-392 monotherapy and along with pembrolizumab in individuals with advanced solid tumours.

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By GlobalData

In March this year, the companies entered a strategic partnership agreement under which BioNTech made an upfront payment of $200m to OncoC4.

Co-developed by the companies, BNT316/ONC-392 is an anti-CTLA-4 antibody candidate.

BioNTech chief medical officer and co-founder professor Özlem Türeci said: “We believe this investigational treatment has the potential to become a new option for patients with late-stage NSCLC who have an otherwise poor prognosis.

“Given its specific mode of action, this treatment approach may also be applicable in a synergistic combination with other immunotherapeutic modalities to provide benefit to further patient populations.”

In January this year, BioNTech entered a memorandum of understanding with the UK government to offer tailored messenger ribonucleic acid (mRNA) cancer immunotherapies for up to 10,000 patients by 2030.