Princeton, NJ (Press Release) – The U.S. Food and Drug Admin­istra­tion (FDA) has placed a partial clin­i­cal hold on CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142, three clin­i­cal trials in­vesti­gating Opdivo (nivolumab)-based com­bi­na­tions in patients with re­lapsed or refractory multiple myeloma.

This partial clin­i­cal hold is related to risks identified in trials studying another anti–PD-1 agent, pem­bro­lizu­mab, in patients with multiple myeloma. The FDA determined data cur­rently avail­able from non-Opdivo studies indicate the risks of PD-1/PD-L1 treat­ment plus poma­lido­mide or lena­lido­mide and possibly PD-1/PD-L1 treat­ments alone or with other com­bi­na­tions outweigh poten­tial benefit for …

Silver Spring, MD (Press Release) – Based on data from two recently halted clin­i­cal trials, the U.S. Food and Drug Admin­istra­tion today is issuing this state­ment to inform the public, health care professionals, and on­col­ogy clin­i­cal investigators about the risks asso­ci­ated with the use of KEYTRUDA® (pem­bro­lizu­mab) in com­bi­na­tion with dexa­meth­a­sone and an immuno­modu­la­tory agent (lena­lido­mide or poma­lido­mide) for the treat­ment of patients with multiple myeloma. KEYTRUDA® (pem­bro­lizu­mab) is not approved for treat­ment of multiple myeloma.

The FDA state­ment is based on review of data from two clin­i­cal trials (KEYNOTE-183 and KEYNOTE-185) eval­u­ating …

Kenilworth, NJ (Press Release) – Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Admin­istra­tion (FDA) has placed a clin­i­cal hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combi­na­tion studies of KEYTRUDA® (pembro­lizu­mab), the com­pany’s anti-PD-1 ther­apy, in the blood cancer multiple myeloma. This de­ci­sion follows a review of data by the Data Monitor­ing Committee in which more deaths were observed in the KEYTRUDA arms of KEYNOTE-183 and KEYNOTE-185 and which led to the pause in new patient enroll­ment, as announced on June 12, …

Kenilworth, NJ (Press Release) – Merck (NYSE:MRK), known as MSD outside the United States and Canada, today provided an update on two com­bi­na­tion studies of KEYTRUDA® (pem­bro­lizu­mab), the com­pany’s anti-PD-1 ther­apy, in the blood cancer multiple myeloma. Merck has accepted the external Data Monitoring Committee recom­men­da­tion to pause new enrollment on KEYNOTE-183 and KEYNOTE-185, two studies exploring KEYTRUDA treat­ment in com­bi­na­tion with other ther­a­pies in multiple myeloma. The pause is to allow for addi­tional in­­for­ma­tion to be collected to better under­stand more reports of death in the KEYTRUDA groups. Patients cur­rently enrolled in …

• Phase Ib/II studies of dara­tu­mu­mab in com­bi­na­tion with Bristol-Myers Squibb’s (BMS) immune checkpoint inhibitor nivolumab in solid tumors and multiple myeloma to start in 2017
• Studies conducted under a clin­i­cal trial col­lab­o­ration agree­ment be­tween Janssen and BMS

Copenhagen, Denmark – Genmab A/S (Nasdaq Copenhagen: GEN) announced today dara­tu­mu­mab will be in­ves­ti­gated in Phase Ib/II clin­i­cal studies in com­bi­na­tion with nivolumab (a PD-1 check­point inhibitor) in several solid tumor types and in multiple myeloma. The studies will be conducted under a clin­i­cal trial col­lab­ora­tion agree­ment be­tween Genmab’s licensing partner for dara­tu­mu­mab, Janssen Biotech, Inc., and Bristol-Myers Squibb (BMS). The studies will be sponsored by BMS.

The solid tumor studies will eval­u­ate the safety, tolerability and clin­i­cal benefit of dara­tu­mu­mab in com­bi­na­tion with nivolumab …

Phase 1b/Phase 2 studies planned in multiple myeloma and solid tumors

Horsham, PA (Press Release) – Janssen Biotech, Inc. today announced that the com­pany has entered a clin­i­cal trial col­lab­o­ration with Bristol-Myers Squibb Company (BMS) to eval­u­ate the com­bi­na­tion of the first CD38-directed cytolytic anti­body dara­tu­mu­mab (DARZALEX®) and checkpoint inhibitor nivolumab (OPDIVO®) in Phase 1b /Phase 2 clin­i­cal studies in multiple myeloma and several solid tumor types. Nivolumab is devel­oped and com­mer­cial­ized by BMS. Janssen licensed dara­tu­mu­mab from Genmab A/S and is responsible for all global devel­op­ment, mar­ket­ing and manu­fac­tur­ing.

The multiple myeloma study will eval­u­ate the safety and tolerability of dara­tu­mu­mab in com­bi­na­tion with nivolumab …

Philadelphia, PA and Oxford, United Kingdom (Press Release) – Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in T-cell ther­apy to treat cancer, today announced that it has entered into a clin­i­cal trial col­lab­o­ration agree­ment with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), for the assess­ment of Adaptimmune’s NY-ESO SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell ther­apy in com­bi­na­tion with MSD’s anti-programmed death-1 (PD-1) inhibitor, KEYTRUDA® (pem­bro­lizu­mab), in patients with multiple myeloma. The study will eval­u­ate the safety, phar­ma­co­ki­netics, pharmacodynamics, and pre­lim­i­nary efficacy of the …