As researchers search for new treat­ments for multiple myeloma, they are particularly interested in uncovering ther­a­pies that address the dis­ease in new ways. Survival and the chance for a cure are likely to be im­proved the most by new treat­ments that are noticeably dif­fer­en­t from other myeloma ther­a­pies.

One of the reasons Darzalex (dara­tu­mu­mab), for example, has been such an im­por­tant new treat­ment for multiple myeloma is because it rep­re­sents a new way of treating the dis­ease. Darzalex was not just another immuno­modu­la­tory agent, like Revlimid (lena­lido­mide) or thalido­mide, and not just …

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 …

• Based on a recent planned review, the Data Monitoring Committee (DMC) rec­om­mends Phase Ib/II study of dara­tu­mu­mab plus atezo­lizu­mab (anti PD-L1 anti­body) in patients with pre­vi­ously treated non-small cell lung cancer to be terminated.
• Phase I MMY2036 study of dara­tu­mu­mab plus JNJ-63723283 (anti PD-1 anti­body) in patients with multiple myeloma, dis­con­tinued
• Health Authorities have been informed about these events and Janssen has contacted its partner com­panies conducting dara­tu­mu­mab and anti-PD-(L)1 com­bi­na­tion studies to discuss ceasing enrollment and dosing of the com­bi­na­tion while the data is being further in­ves­ti­gated

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that fol­low­ing a planned review, the DMC has rec­om­mended that the Phase Ib/II study (CALLISTO/LUC2001) of dara­tu­mu­mab in com­bi­na­tion with atezo­lizu­mab versus atezo­lizu­mab mono­therapy in patients with previ­ously treated ad­vanced or metastatic non-small cell lung cancer should be terminated. In addi­tion the phase I MMY2036 study of dara­tu­mu­mab plus JNJ-63723283, an anti PD-1 anti­body in patients with multiple myeloma will be dis­con­tinued.

The DMC de­ter­mined that there was no observed benefit within …

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

 …

Basel, Switzerland (Investor Update) – Roche (SIX: RO, ROG; OTCQX: RHHBY): today announced that fol­low­ing close consultation and agree­ment on study modifications with the U.S. Food and Drug Admin­istra­tion (FDA), the partial clin­i­cal holds placed on the Phase Ib and Phase Ib/II studies eval­u­ating TECENTRIQ in com­bi­na­tion with an immuno­modu­la­tory medicine (IMiD) in re­lapsed/refractory multiple myeloma and re­lapsed/refractory follicular lym­phoma have been lifted. The studies will con­tinue in accordance with the protocol amendments agreed upon by the FDA.

The studies had been placed on partial clin­i­cal hold as part of an FDA evaluation …

Basel, Switzerland (Press Release) – Roche (SIX: RO, ROG; OTCQX: RHHBY): Based on emerging safety data from clin­i­cal trials eval­u­ating pembro­lizumab in com­bi­na­tion with either lena­lido­mide or poma­lido­mide in multiple myeloma, the FDA has requested that a Phase Ib and a Phase Ib/II TECENTRIQ study be placed on partial clin­i­cal hold. At Roche/Genentech we remain committed to patient safety and will con­tinue to work closely with the FDA. It is our under­stand­ing that the FDA is eval­u­ating all ongoing blood cancer trials investigating an anti-PD1/PDL1 medicine in com­bi­na­tion with an immuno­modu­latory medicine …

Summit, NJ (Press Release) –  Celgene Corpo­ra­tion (NASDAQ:CELG) today announced that the U.S. Food and Drug Admin­istration (FDA) has placed a partial clin­i­cal hold on five trials and a full clin­i­cal hold on one trial in the Celgene FUSION™ pro­gram. The trials are testing IMFINZI™ (durva­lumab), an anti-PD-L1 anti­body, in combi­nation with immuno­modulatory and chemo­therapy agents in blood cancers such as multiple myeloma, chronic lym­pho­cytic leukemia and lym­phoma.

The de­ci­sion by the FDA was based on risks identified in other trials for an anti-PD-1 anti­body, pem­bro­lizu­mab, in patients with multiple myeloma in …