The first study, Javelin Gastric 100, will compare the switch from first-line chemotherapy to maintenance therapy with avelumab versus continuation of chemotherapy.
It will evaluate the potential superiority of maintenance therapy in patients with unresectable, locally advanced or metastatic gastric/GEJ cancers whose disease did not progress with first-line platinum-based chemotherapy.
Under the randomized, open-label trial, 629 patients will be enrolled across more than 220 sites in Asia Pacific, Europe, North America and South America.
The second trial, Javelin Gastric 300, will assess the superiority of avelumab compared to the investigator’s choice of chemo from a pre-specified list of options in patients with unresectable, recurrent or metastatic gastric/GEJ cancers.
The randomized, open-label trial will enroll about 330 subjects across 170 sites in the similar regions as the Javelin Gastric 100 study.
Merck’s US and Canadian biopharma business, EMD Serono, will carry out the studies for both of the gastric/GEJ Phase III trials in North America on behalf of the company.
The clinical development program for avelumab currently includes over 1,500 patients who have been treated across more than 15 tumor types.
Avelumab, also known as MSB0010718C, inhibits PD-L1 interactions to potentially allow the activation of T-cells and the adaptive immune system.
It is believed to engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity by retaining a native Fc-region.
Last month, the US Food and Drug Administration granted breakthrough therapy designation for avelumab to treat metastic Merkel cell carcinoma following progression on at least one prior chemotherapy regimen.
Image: Avelumab inhibits PD-L1 interactions to potentially allow the activation of T-cells and the adaptive immune system. Photo: courtesy of Merck KGaA, Darmstadt, Germany.