Calgary, AB and San Diego, CA (Press Release) – Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), cur­rently devel­op­ing pelareorep, an in­tra­venously delivered immuno-oncolytic virus, today announced that the first patient was treated in a phase 1 dose escalation study combining pelareorep and car­filz­o­mib with Bristol-Myers Squibb’s checkpoint inhibitor Opdivo® (nivolumab) to treat re­lapsed multiple myeloma patients. This study is based on findings from the NCI 9603 multiple myeloma study that com­bined pelareorep with car­filz­o­mib that resulted in objective responses, elimination of multiple myeloma cells and most importantly, an inflamed pheno­type with PD-L1 …

FDA action removes partial hold on CheckMate -602, the last of holds pre­vi­ously placed on three Opdivo-based com­bi­na­tion trials in re­lapsed or refractory multiple myeloma

Princeton, NJ (Press Release) – Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Admin­istra­tion (FDA) lifted a partial clin­i­cal hold placed on CA209-602 (CheckMate -602), a ran­domized, open-label Phase 3 study eval­u­ating the addi­tion of Opdivo (nivolumab) to poma­lido­mide and dexa­meth­a­sone in patients with re­lapsed or refractory multiple myeloma. The de­ci­sion follows consultation with the FDA and agree­ment on amendments to the study protocol.

Three trials eval­u­ating Opdivo-based com­bi­na­tions in re­lapsed or refractory multiple myeloma were placed on partial clin­i­cal hold in September 2017 as an FDA …

Princeton, NJ (Press Release) – Bristol-Myers Squibb Company (NYSE: BMY) today announced the U.S. Food and Drug Admin­istra­tion (FDA) has lifted partial clin­i­cal holds placed on CA209 -039 (CheckMate -039) and CA204142, the phase 1 and 2 clin­i­cal trials investigating Opdivo (nivolumab)-based com­bi­na­tions in patients with re­lapsed or refractory multiple myeloma, re­spec­tive­ly. The de­ci­sion follows consultation with the FDA and agree­ment on amendments to the study protocols. Patient enrollment for the fol­low­ing trials will resume in accordance with the amendments:

• CheckMate -039: A phase 1 study to establish the tolerability of

 …

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 …

• 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 …