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 …

• DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients
• Today's FDA approval of DARZALEX® in com­bi­na­tion with bortez­o­mib, mel­phalan and pred­ni­sone marks its fifth indi­ca­tion in multiple myeloma

Horsham, PA (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson an­nounced today that the U.S. Food and Drug Admin­istra­tion (FDA) has approved DARZALEX® (dara­tu­mu­mab) in combi­na­tion with VELCADE® (bor­tez­o­mib)*, a pro­teasome inhibitor (PI); mel­phalan, an alkylat­ing agent; and pred­ni­sone – VMP – for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for autol­o­gous stem cell trans­plant (ASCT). DARZALEX® is the first mono­clonal anti­body approved for newly diag­nosed patients with this disease. Clinical trial results showed DARZALEX® in combi­na­tion with …

• DARZALEX (dara­tu­mu­mab) approved by U.S. FDA in com­bi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant
• First approval for DARZALEX in a frontline indi­ca­tion

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istra­tion (U.S. FDA) has approved the use of DARZALEX® (dara­tu­mu­mab) in combi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone (VMP) for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The supple­mental Biologics License Appli­cation (sBLA) for this indi­ca­tion was submitted by Genmab’s licensing part­ner, Janssen Biotech, Inc., in November 2017. The U.S. FDA sub­se­quently granted priority review to the …

The results of a small, single-arm study conducted at the Ohio State University indicate that adminis­tering Darzalex using a time-saving 90-minute in­fusion protocol can be safe.

No patients in the study ex­peri­enced severe in­fusion-related reac­tions, and there was only one mild reac­tion in a patient who had no further reac­tions during sub­se­quent in­fusions at the 90-minute rate.

The faster Darzalex (dara­tu­mu­mab) in­fusion rate tested in the study is two hours shorter than the standard 3.5 hour rate. Patients in the study were receiving their third, or sub­se­quent, Darzalex in­fusions.

Infusion-related …

• U.S. FDA grants Priority Review to dara­tu­mu­mab in combi­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma in­eli­gible for au­tol­o­gous stem cell trans­plant
• May 21, 2018 PDUFA date

Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Admin­istration (FDA) has granted Priority Review to the supple­mental Biologics License Application (sBLA) for the use of dara­tu­mu­mab (DARZALEX®) in combi­­na­tion with bor­tez­o­mib, mel­phalan and pred­ni­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­plant (ASCT). The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., in November 2017. Priority Review is an FDA desig­na­tion …

Supplemental Biologics License Application (sBLA) seeks first indi­ca­tion for DARZALEX for the treat­ment of newly diag­nosed patients

Raritan, NJ (Press Release) – Janssen Biotech, Inc. today announced that it has submitted a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) for DARZALEX® (dara­tu­mu­mab). This appli­ca­tion seeks to expand the current indi­ca­tion, using DARZALEX in com­bi­na­tion with bor­tez­o­mib (a pro­te­a­some inhibitor [PI]), mel­phalan and pred­ni­sone, for the treat­ment of patients with newly diag­nosed multiple myeloma who are in­eli­gible for au­tol­o­gous stem cell trans­planta­tion (ASCT). If approved, this would be the fifth indi­ca­tion for DARZALEX in the U.S. and its first in the frontline setting.

"The addi­tion …