A Phase 3 trial of Bavencio (avelumab) in people with squamous cell carcinoma of the head and neck (SCCHN) was ended early due to a lack of effectiveness seen in an interim analysis, the companies that developed and are marketing the treatment announced.
Data from the study, named JAVELIN Head and Neck 1oo (NCT02952586), showed that Bavencio failed to provide significant benefits in the primary measurement of efficacy — progression free survival — the amount of time patients go without disease progression while using or after finishing treatment.
SCCHN is the sixth most frequent cancer globally. About 60% of new SCCHN diagnoses do not occur until the cancer is in a locally advanced stage. This means that the cancer has spread from the initial site to nearby lymph nodes or tissue, but not to more distant place in the body.
Typically, SCCHN is treated with an aggressive combination of chemotherapy and radiotherapy. However, cancer relapses are common in these patients.
The JAVELIN Head and Neck 100 study, sponsored by Pfizer, was evaluating Bavencio plus standard care in treating locally advanced SCCHN.
Bavencio, marketed by Pfizer and EMD Serono (known as Merck KGaA outside of North America), is an immune checkpoint inhibitor that blocks the binding of the PD-1 protein in immune T-cells to PD-L1 in cancer cells. This is intended to prevent a common strategy used by tumors to evade immune attack and to boost anti-cancer responses.
The double-blind trial recruited 697 patients with previously untreated, locally advanced SCCHN. All were treated with the standard chemotherapy cisplatin and radiotherapy, along with either Bavencio or a placebo given by intravenous infusion (directly into the bloodstream) every two weeks for one year.
But in a pre-planned analysis conducted by an independent Data Monitoring Committee (DMC), it was determined that Bavencio’s use was unlikely to significantly extend progression-free survival compared to placebo. As such, the Committee recommended to terminate the trial, the companies said in a press release.
This trial was originally set to run until 2022. A detailed analysis of the data will be presented to the scientific community.
The study’s early end followed results late last year showing that, compared to standard care, Bavencio failed to extend survival for people with advanced stomach or gastroesophageal junction cancer in the JAVELIN Gastric 100 trial (NCT02625610).
Bavencio was approved by the U.S. Food and Drug Administration as a treatment for metastatic Merkel cell carcinoma and urothelial carcinoma in 2017. It was also recently approved to treat advanced kidney cancer in the EU, in combination with Pfizer’s Inlyta (axitinib).
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