Merck and Pfizer Inc. announced topline results of the Phase III JAVELIN Gastric 100 study evaluating avelumab as first-line maintenance therapy following induction chemotherapy in patients with unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) cancer versus continuation of chemotherapy or best supportive care. While the study showed clinical activity for avelumab in this setting, it did not meet the primary endpoints of superior overall survival compared with the standard of care in the overall intent-to-treat population (n=499; HR: 0.91; 95% CI: 0.74, 1.11) or the PD-L1–positive population (n=54; HR: 1.13; 95% CI: 0.57, 2.23).
"Advanced gastric cancer is a hard-to-treat tumor, and there is a key unmet need for additional treatments. Additionally, it is rarely immunogenic, and to date no immune checkpoint inhibitor has demonstrated superiority to the current standard of care with chemotherapy," said Prof. Dr. Markus Mohler, Head of GI Oncology, Senior Physician Gastroenterology & Endosonography, Johannes-Gutenberg University, Mainz, Germany and coordinating investigator. "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."
No new safety signals were observed, and the safety profile for avelumab in this trial was consistent with that observed in the overall JAVELIN clinical development program. A detailed analysis of the Phase III JAVELIN Gastric 100 study is being conducted to better understand the results, and findings will be shared with the scientific community.
About JAVELIN Gastric 100
JAVELIN Gastric 100 (NCT02625610) is a Phase III, multicenter, randomized, open-label trial investigating maintenance therapy with avelumab in patients with HER2-negative advanced (unresectable, locally advanced or metastatic) adenocarcinoma of the stomach or of the gastroesophageal junction (GEJ) who have not yet received chemotherapy for the treatment of metastatic or locally advanced disease, in an overall population unselected for PD-L1 expression. A total of 805 patients were enrolled to receive induction (initial) chemotherapy with oxaliplatin and either 5-fluorouracil (5-FU) or capecitabine for 12 weeks. Of these, 499 patients whose disease had not progressed at the end of the 12 weeks of chemotherapy treatment were randomly assigned to receive either avelumab as a maintenance treatment or continuation of the same chemotherapy regimen until disease progression. Patients unfit for further chemotherapy received best supportive care. The primary endpoints are overall survival in all randomized patients or in the PD-L1+ population (≥1%).
About Gastric Cancer
Globally, gastric cancer is the third most common cause of cancer death.1 The standard first-line option for patients with HER2-negative disease is chemotherapy,2 yet patients with advanced disease can experience resistance, leading to a poor prognosis.3 Over the past decade, there have been limited advancements in treatment,4 and the median overall survival for patients at the advanced stage is less than one year.5 In recognition of the significant need, the Merck-Pfizer alliance initiated a Phase III trial to assess a novel first-line maintenance approach in advanced gastric cancer, to understand the potential of checkpoint inhibitor treatment following confirmed response or stabilization of disease on induction chemotherapy.
About the JAVELIN Clinical Development Program
The clinical development program for BAVENCIO, known as JAVELIN, involves more than 10,000 patients evaluated across more than 15 different tumor types. In addition to gastric/gastroesophageal junction cancer, these tumor types include head and neck cancer, Merkel cell carcinoma, non-small cell lung cancer, renal cell and urothelial carcinoma.
About BAVENCIO® (avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to rele...
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