Janssen Biotech, the Johnson & Johnson sub­sid­i­ary that mar­kets the myeloma ther­apy Darzalex globally, has decided to halt two clin­i­cal trials testing the drug in com­bi­na­tion with other cancer treat­ments.

One of the Darzalex trials involves patients with pre­vi­ously treated metastatic non-small cell lung cancer, while the other trial involves patients with re­lapsed or refractory multiple myeloma.

Genmab, the Danish com­pany that initially devel­oped Darzalex (dara­tu­mu­mab) before licensing it to Janssen, announced news of the trial can­cel­la­tions this past Saturday.

Genmab reported that, in the lung cancer trial, no benefit was seen …

• 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 …

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 …

Janssen and Genentech will enter clin­i­cal col­lab­o­ra­tion to assess dual mono­clonal anti­body (mAb) combi­na­tion ther­apy

Raritan, NJ (Press Release) – Janssen Research & Development, LLC announced today it has entered into a clin­i­cal trial col­lab­o­ra­tion agree­ment with Genentech, a member of the Roche Group, to ini­ti­ate two studies to de­ter­mine the safety and tolerability of dara­tu­mu­mab (DARZALEX®), the first CD38-directed mono­clonal anti­body (mAb), in combi­na­tion with atezo­lizu­mab, an investi­ga­tional mAb designed to bind with a protein called pro­grammed cell death-ligand 1 (PD-L1). These studies will assess the poten­tial of the combi­na­tion ther­apy in multiple myeloma and in solid tumor. Atezolizumab is cur­rently in devel­op­ment by Roche. Janssen …

• Phase Ib studies of dara­tu­mu­mab in com­bi­na­tion with Roche’s immune checkpoint inhibitor atezo­lizu­mab in a solid tumor and multiple myeloma to be started
• Studies conducted under a clin­i­cal trial col­lab­o­ra­tion agree­ment be­tween Janssen and Roche

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that dara­tu­mu­mab will be in­ves­ti­gated in early stage clin­i­cal studies in com­bi­na­tion with atezo­lizu­mab (anti-PD-L1 anti­body), in a solid tumor and multiple myeloma. The studies will be conducted under a clin­i­cal trial col­lab­o­ra­tion agree­ment be­tween Genmab’s licensing partner for dara­tu­mu­mab, Janssen Biotech, Inc., and Genentech, a member of the Roche Group. Atezolizumab is an inves­ti­ga­tional mono­clonal anti­body de­signed to bind to a protein called PD-L1, which is ex­pressed on tumor cells and …