Update on Javelin Ovarian 100 Trial

Mer­ck and Pfiz­er Inc. announced that data from a planned inter­im analy­sis of the Phase III Javelin Ovar­i­an 100 study of avelum­ab did not sup­port the study’s ini­tial hypoth­e­sis, and there­fore the alliance made the deci­sion to ter­mi­nate the tri­al in align­ment with the inde­pen­dent Data Mon­i­tor­ing Committee.

The Mer­ck-Pfiz­er alliance was the first to test an immunother­a­py in this indi­ca­tion, giv­en the sig­nif­i­cant unmet need in the treat­ment of ovar­i­an can­cer. Four out of five women with ovar­i­an can­cer are diag­nosed at advanced stages.1 Most women with advanced ovar­i­an can­cer ulti­mate­ly die with­in five years due to refrac­to­ry, resis­tant or recur­rent disease.

Topline results showed that the study, which is eval­u­at­ing avelum­ab in com­bi­na­tion with and/or fol­low­ing plat­inum-based chemother­a­py in pre­vi­ous­ly untreat­ed patients with ovar­i­an can­cer, would not achieve supe­ri­or­i­ty in the pre-spec­i­fied pri­ma­ry end­point of pro­gres­sion-free sur­vival. While detailed analy­ses of the data are ongo­ing, no new safe­ty sig­nals were observed, and the safe­ty pro­file for avelum­ab in this tri­al appears con­sis­tent with that observed in the over­all Javelin clin­i­cal devel­op­ment pro­gram. The alliance has noti­fied health author­i­ties and tri­al inves­ti­ga­tors of the inter­im find­ings and the deci­sion to dis­con­tin­ue the tri­al. Detailed results will be shared with the sci­en­tif­ic com­mu­ni­ty. The Javelin Ovar­i­an Parp 100 study and ear­li­er phase stud­ies inves­ti­gat­ing avelum­ab in var­i­ous com­bi­na­tions are ongoing.