EMD Serono and Pfizer Halt Phase III Head and Neck Cancer Trial

Clinical Trial Stop

Pfizer and EMD Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, jointly announced that their Phase III JAVELIN Head and Neck 100 trial of Bavencio (avelumab) with chemoradiotherapy (CRT) for untreated locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) was unlikely to hit the primary endpoint. As such, they have shuttered that trial.

The study was evaluating Bavencio and CRT compared to standard-of-care CRT in the patient population. An independent Data Monitoring Committee (DMC) recommended the companies terminate the study because it was unlikely to show a statistically significant improvement in the primary endpoint, which was progression-free survival (PFS) based on a preplanned interim analysis.

Bavencio is a checkpoint inhibitor approved for advanced renal cell carcinoma (kidney cancer), urothelial carcinoma and Merckel cell carcinoma.

The JAVELIN Head and Neck 100 study is a Phase III, randomized, double-blind, placebo-controlled, parallel-arm trial with a total of 697 patients who had not received previous therapy for locally advanced SCCHN and were eligible for CRT with curative intent. The patients were randomized to receive Bavencio plus CRT or CRT alone. Secondary endpoints included overall survival (OS), time to locoregional failure, time to distant metastatic failure, overall response, duration of response and pathologic complete response.

Head and neck cancer is the sixth most common globally.

In January, EMD Serono and Pfizer announced that the Phase III JAVELIN Bladder 100 trial met its primary endpoint of OS at the planned interim analysis. In that trial, patients with previously untreated locally advanced or metastatic urothelial carcinoma (UC) who did not progress on induction chemotherapy and who were randomized to receive first-line maintenance with Bavencio and best supportive care lived significantly longer than those who received BSC only.

“Bavencio is the first immunotherapy to demonstrate in a clinical trial a statistically significant improvement in overall survival as a first-line treatment for patients with advanced urothelial carcinoma,” Chris Boshoff, chief development officer, Oncology, Pfizer Global Product Development, said at the time. “These latest positive data from the JAVELIN clinical development program add to the body of evidence for BAVENCIO in the treatment of genitourinary cancers, and we look forward to discussing these results with health authorities.”

UC makes up about 90% of bladder cancer. Metastatic bladder cancer has a five-year survival rate of 5%.

Earlier, on November 8, 2019, the two companies announced topline data from the Phase III JAVELIN Gastric 100 trial of Bavencio as first-line maintenance therapy after induction chemotherapy in unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) cancer compared to continuation of chemotherapy or best supportive care. The trial showed clinical activity for Bavencio in that setting but did not meet the primary endpoints of superior OS compared with the standard of care in that patient population.

“Advanced gastric cancer is a hard-to-treat tumor, and there is a key unmet need for additional treatments,” said Markus Mohler, Head of GI Oncology, Senior Physician Gastroenterology & Endosonography, Johannes-Gutenberg University in Mainz, Germany and coordinating investigator, at the time. “Additionally, it is rarely immunogenic, and to date no immune checkpoint inhibitor has demonstrated superiority to the current standard of care with chemotherapy. As we have yet to define the ideal strategy for incorporating immunotherapy in the continuum of care, the results of JAVELIN Gastric 100 will provide essential information in advancing our understanding and potential treatment options of this challenging disease.”

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