Phase 3 trial did not meet pri­mary end­point of pro­gres­sion-free sur­vival in patients not eli­gible for trans­plant

Princeton, NJ (Press Release) – Bristol Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced top­line re­­sults from ELOQUENT-1, a Phase 3, ran­dom­ized, open-label trial eval­u­ating the com­bi­na­tion of Empliciti (elo­tuzu­mab) plus Revlimid (lena­lido­mide) and dexa­meth­a­sone (ERd), versus Revlimid and dexa­meth­a­sone alone (Rd), in patients with newly diag­nosed, pre­vi­ously untreated mul­ti­ple myeloma who are trans­plant in­eli­gible. Both treat­ments were admin­istered con­tin­uously until dis­ease pro­gres­sion. At final analysis, the addi­tion of Empliciti did not show a statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free sur­vival (PFS), the study’s pri­mary end­point. The safety profile of ERd was generally con­sis­tent …

• Median pro­gres­sion-free sur­vival and over­all re­sponse rate doubled among patients re­ceiv­ing EPd com­pared to poma­lido­mide and low-dose dexa­meth­a­sone alone
• Second Empliciti-based com­bi­na­tion approved in Europe for patients with re­lapsed and re­frac­tory mul­ti­ple myeloma

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Com­mis­sion (EC) has approved Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. This ap­prov­al is based on data from the ELOQUENT-3 trial in which EPd doubled both median pro­gres­sion-free sur­vival (PFS) and …

Here in “Space City,” we’ve been celebrating an im­por­tant mile­stone. It was 50 years ago when the unthinkable was accomplished, and we became a lunar people. On July 20, 1969 at 10:56 p.m., astronauts Neil Armstrong and Edwin “Buzz” Aldrin became the first men to walk on the Moon. With astronaut Michael Collins piloting the capsule, Houston Capcom monitoring the mis­sion, and more than half a billion people watching on television, Armstrong climbed down the ladder and proclaimed: "That's one small step for a man, one giant leap for mankind."

The total mis­sion duration …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the Com­mit­tee for Medicinal Products for Human Use (CHMP) of the Euro­pean Medicines Agency has adopted a pos­i­tive opinion on a Type-II variation appli­ca­tion for Empliciti (elo­tuzu­mab) plus poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with re­lapsed and re­frac­tory mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. The CHMP recom­men­da­tion will now be reviewed by the Euro­pean Com­mis­sion, …

• In the ELOQUENT-3 trial, treat­ment with Empliciti plus poma­lido­mide and dexa­meth­a­sone (EPd) doubled median pro­gres­sion-free sur­vival and over­all re­sponse rate versus poma­lido­mide and dexa­meth­a­sone (Pd)¹
• Low dis­con­tinu­a­tion rates due to adverse reac­tions were observed with both EPd and Pd alone¹
• Empliciti, when used in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone, can be admin­istered once monthly after first two cycles¹

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) approved Empliciti (elo­tuzu­mab) in­jec­tion for intra­venous use in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (EPd) for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor.¹ In ELOQUENT-3, a ran­dom­ized, open-label, Phase 2 trial, EPd dem­onstrated ben­e­fit in patients with re­lapsed or re­frac­tory mul­ti­ple myeloma, doubling both median pro­gres­sion-free sur­vival (PFS) …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) to­day an­nounced that the Euro­pean Medicines Agency (EMA) has val­i­dated the Com­pany’s type II variation appli­ca­tion for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of adult patients with mul­ti­ple myeloma who have re­ceived at least two prior ther­a­pies, in­cluding lena­lido­mide and a pro­te­a­some in­hib­i­tor (PI), and have dem­onstrated dis­ease pro­gres­sion on the last ther­apy. Validation of the appli­ca­tion con­firms the sub­mission is com­plete and begins the EMA’s centralized review process.

“Given the need for new treat­ment …

Application based on re­­sults from Phase 2 ELOQUENT-3 study

Princeton, NJ (Press Release) - Bristol-Myers Squibb Com­pany (NYSE:BMY) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) ac­cepted its supple­mental Biologics License Appli­ca­tion (sBLA) for Empliciti (elo­tuzu­mab) in com­bi­na­tion with poma­lido­mide and low-dose dexa­meth­a­sone (EPd) for the treat­ment of patients with re­lapsed / re­frac­tory mul­ti­ple myeloma (RRMM) who have re­ceived at least two prior ther­a­pies, in­­clud­ing lena­lido­mide and a pro­te­a­some in­hib­i­tor. The FDA granted the appli­ca­tion priority review with an action date of De­cem­ber 27, 2018.

“This file ac­ceptance is an im­por­tant step in BMS’s on­go­ing efforts to ad­vance …