Alongside US pharmaceutical firm Pfizer, German drugmaker Merck have started a Phase III trial (JAVELIN Lung 100) of avelumab in patients with recurrent or stage IV non-small cell lung cancer (NSCLC).
The trial is designed to evaluate the safety and efficacy of avelumab compared with platinum-based doublet chemotherapy.
Patients targeted will have late-stage NSCLC and had no previous treatment for their systemic lung cancer.
Avelumab is a fully human anti-PD-L1 IgG1 monoclonal antibody. It potentially uses the body’s immune system to combat cancer.
Around 420 patients with recurrent or stage IV PD-L1+ NSCLC will be enrolled in this open-label, multi-centre, randomised clinical trial.
They will receive either avelumab or platinum-based chemotherapy as first-line treatment, based on their histology.
For PD-L1+ status, patients will be pre-screened using an immunohistochemistry-based companion diagnostic test.
The trial will enrol patients across more than 240 sites in Africa, the Americas, Asia and Europe.
In North America, trials will be carried out by EMD Serono, the Merck’s US and Canadian biopharma business.
Merck global head of research and development of the biopharma business Luciano Rossetti said: "Through this Phase III trial, we hope to gain a better understanding of avelumab as a potential first-line treatment for non-small cell lung cancer.
"We are working to help patients with this challenging cancer and will continue to develop our NSCLC programme by evaluating avelumab as a potential monotherapy."
The trial’s primary endpoint is progression-free survival (PFS) in patients with PD-L1+ tumours.
Secondary endpoints include PFS in patients with strongly PD-L1 positive (PD-L1++) tumours, overall survival, objective response rate, quality of life, tolerability and safety.
JAVELIN Lung 100 is the second Phase III trial assessing avelumab in NSCLC.
Since April, the first trial is evaluating avelumab in patients whose disease has progressed after receiving a platinum-containing doublet chemotherapy, compared with docetaxel.
Image: Micrograph of squamous cell carcinoma. Photo: courtesy of Nephron.