Application is based on pos­i­tive data from the Phase 3 CANDOR study, which were pre­sented at the 2019 American Society of Hematology Annual Meeting

Raritan, NJ (Press Release) – The Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson announced today the sub­mission of a supple­mental Biologics License Application (sBLA) to the U.S. Food and Drug Admin­istra­tion (FDA) seeking approval of DARZALEX® (dara­tu­mu­mab) in com­bi­na­tion with Kyprolis® (car­filz­o­mib) and dexa­meth­a­sone (DKd) for re­lapsed / re­frac­tory multiple myeloma. The sBLA is sup­ported by results from the Phase 3 CANDOR study, which com­pared treat­ment with DKd to car­filz­o­mib and dexa­meth­a­sone (Kd) in patients with multiple myeloma who re­lapsed after one to three prior lines of ther­apy.

"While we con­tinue to make im­por­tant strides in the treat­ment of multiple myeloma, unfortunately most patients will relapse at some point, so it is im­por­tant that physicians have multiple treat­ment options and regi­mens for patients," said Craig Tendler, M.D., Vice Pres­i­dent, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. "The results from the CANDOR study sup­port the poten­tial benefit of this DARZALEX-based com­bi­na­tion regi­men for patients with multiple myeloma who have re­lapsed from prior treat­ment."

Data from the Phase 3 CANDOR study were pre­sented as a late-breaking abstract at the 2019 American Society of Hematology (ASH) Annual Meeting.

About the CANDOR Study

CANDOR is a ran­dom­ized, open-label Phase 3 study of DARZALEX® (dara­tu­mu­mab), car­filz­o­mib and dexa­meth­a­sone (DKd) com­pared to car­filz­o­mib and dexa­meth­a­sone (Kd) alone. The study eval­u­ated 466 re­lapsed or re­frac­tory patients with multiple myeloma who had re­ceived one to three prior lines of ther­apy from 120 global sites. Patients were treated until dis­ease pro­gres­sion. The pri­mary end­point was pro­gres­sion free sur­vival (PFS), and the key sec­ond­ary end­points were over­all re­sponse­ rate, minimal residual dis­ease and over­all sur­vival. PFS was defined as time from ran­dom­i­za­tion until dis­ease pro­gres­sion or death from any cause.

All patients re­ceived car­filz­o­mib as a 30-minute in­tra­venous (IV) in­fusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m2 on days 1 and 2 during cycle 1 and 56 mg/m2 there­after) and re­ceived 40 mg dexa­meth­a­sone oral or IV weekly (20 mg/m2 for patients aged >75 years). In the treat­ment arm, DARZALEX® 8 mg/kg was admin­istered IV on days 1 and 2 of cycle 1 and 16 mg/kg IV once weekly for the remaining doses of the first two cycles, then every two weeks for four cycles (cycles 3 to 6), and every four weeks there­after.

CANDOR is an Amgen-sponsored study and is co-funded by Janssen Research & Development, LLC. For more in­for­ma­tion about this trial, please visit www.clinicaltrials.gov under trial identi­fi­ca­tion number NCT03158688.

About DARZALEX® (dara­tu­mu­mab)

DARZALEX® (dara­tu­mu­mab), the first mono­clonal anti­body for multiple myeloma approved any­where in the world, is the only CD38-directed anti­body approved to treat multiple myeloma.¹ CD38 is a surface protein that is present in high numbers on multiple myeloma cells, re­gard­less of the stage of dis­ease.² DARZALEX® binds to CD38 and inhibits tumor cell growth causing myeloma cell death.³ DARZALEX® may also have an effect on nor­mal cells.³ DARZALEX® is being eval­u­ated in a com­pre­hen­sive clin­i­cal devel­op­ment pro­gram across a range of treat­ment settings in multiple myeloma, such as in front­line and re­lapsed settings.^{3,4,5,6,7,8,9,10} Additional studies are ongoing or planned to assess its poten­tial in other malignant and pre-malignant hema­to­logic dis­eases in which CD38 is ex­pressed, such as smol­der­ing myeloma.^11,12

In the U.S., DARZALEX® re­ceived initial FDA approval in No­vem­ber 2015 as a mono­therapy for patients with multiple myeloma who have re­ceived at least three prior lines of ther­apy, in­clud­ing a pro­te­a­some in­hib­i­tor (PI) and an immuno­modu­la­tory agent, or who are double re­frac­tory to a PI and an immuno­modu­la­tory agent.¹³ DARZALEX® re­ceived addi­tional approvals in No­vem­ber 2016 in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone, or bor­tez­o­mib and dexa­meth­a­sone, for the treat­ment of patients with multiple myeloma who have re­ceived at least one prior ther­apy.¹⁴ In June 2017, DARZALEX® re­ceived approval in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have re­ceived at least two prior ther­a­pies, in­clud­ing lena­lido­mide and a PI.¹⁵ In May 2018, DARZALEX® re­ceived approval 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), making it the first mono­clonal anti­body approved for newly diag­nosed patients with this dis­ease.¹⁶ In June 2019, DARZALEX® re­ceived approval in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of patients with newly diag­nosed multiple myeloma who are trans­plant in­eli­gible.¹⁷ In Sep­tem­ber 2019, DARZALEX® re­ceived approval in com­bi­na­tion with bor­tez­o­mib, thalido­mide, and dexa­meth­a­sone in newly diag­nosed patients who are eli­gible for ASCT.¹⁸

In August 2012, Janssen Biotech, Inc. entered into a global license and devel­op­ment agree­ment with Genmab A/S, which granted Janssen an ex­clu­sive license to de­vel­op, manu­fac­ture and com­mer­cial­ize DARZALEX®.¹⁹ For the full U.S. Prescribing Information, please visit www.DARZALEX.com.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone mar­row.^20,21 When damaged, these plasma cells rapidly spread and replace nor­mal cells with tumors in the bone mar­row. In 2020, it is esti­mated that 32,270 people will be diag­nosed and 12,830 will die from the dis­ease in the U.S.22 While some patients with multiple myeloma have no symp­toms, most patients are diag­nosed due to symp­toms, which can in­clude bone fracture or pain, low red blood cell counts, tiredness, high cal­cium levels, kidney problems or in­fec­tions.²²

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

DARZALEX® (dara­tu­mu­mab) is con­tra­in­di­cated in patients with a history of severe hypersensitivity (e.g., anaphylactic reac­tions) to dara­tu­mu­mab or any of the components of the for­mu­la­tion.

WARNINGS AND PRECAUTIONS

Infusion Reactions – DARZALEX® can cause severe and/or serious in­fusion reac­tions, in­clud­ing anaphylactic reac­tions. In clin­i­cal trials, approx­i­mately half of all patients ex­peri­enced an in­fusion reac­tion. Most in­fusion reac­tions occurred during the first in­fusion and were Grade 1-2. Infusion reac­tions can also occur with sub­se­quent in­fusions. Nearly all reac­tions occurred during in­fusion or within 4 hours of com­plet­ing DARZALEX®. Prior to the in­tro­duc­tion of post-infusion med­i­ca­tion in clin­i­cal trials, in­fusion reac­tions occurred up to 48 hours after in­fusion. Severe reac­tions have occurred, in­clud­ing bron­cho­spasm, hypoxia, dyspnea, hyper­tension, laryngeal edema, and pul­mo­nary edema. Signs and symp­toms may in­clude res­pira­tory symp­toms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting, and nausea. Less common symp­toms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypo­tension.

Pre-medicate patients with anti­his­ta­mines, anti­pyretics, and corticosteroids. Frequently monitor patients during the entire in­fusion. Interrupt in­fusion for reac­tions of any severity and institute medical man­agement as needed. Permanently dis­con­tinue ther­apy if an anaphylactic reac­tion or life-threatening (Grade 4) reac­tion occurs and institute appro­pri­ate emergency care. For patients with Grade 1, 2, or 3 reac­tions, reduce the in­fusion rate when re-starting the in­fusion.

To reduce the risk of delayed in­fusion reac­tions, admin­ister oral corticosteroids to all patients fol­low­ing DARZALEX® in­fusions. Patients with a history of chronic ob­struc­tive pul­mo­nary dis­ease may require addi­tional post-infusion med­i­ca­tions to man­age res­pira­tory com­pli­ca­tions. Consider pre­scrib­ing short- and long-acting bron­cho­di­lators and inhaled corticosteroids for patients with chronic ob­struc­tive pul­mo­nary dis­ease.

Interference with Serological Testing – Dara­tu­mu­mab binds to CD38 on red blood cells (RBCs) and results in a pos­i­tive Indirect Antiglobulin Test (Indirect Coombs test). Dara­tu­mu­mab-mediated pos­i­tive indirect antiglobulin test may persist for up to 6 months after the last dara­tu­mu­mab in­fusion. Dara­tu­mu­mab bound to RBCs masks detection of anti­bodies to minor an­ti­gens in the patient's serum. The deter­mi­na­tion of a patient's ABO and Rh blood type are not impacted. Notify blood transfusion centers of this inter­fer­ence with serological testing and inform blood banks that a patient has re­ceived DARZALEX®. Type and screen patients prior to starting DARZALEX®.

Neutropenia and Thrombocytopenia – DARZALEX® may in­crease neu­tro­penia and/or thrombo­cyto­penia induced by back­ground ther­apy. Monitor com­plete blood cell counts periodically during treat­ment according to the manu­fac­turer's pre­scrib­ing in­for­ma­tion for back­ground ther­a­pies. Monitor patients with neu­tro­penia for signs of in­fec­tion. DARZALEX® dose delay may be required to allow re­cov­ery of neu­tro­phils and/or platelets. No dose reduction of DARZALEX® is rec­om­mended. Consider sup­port­ive care with growth factors for neu­tro­penia or transfusions for thrombo­cyto­penia.

Interference with Determination of Complete Response – Dara­tu­mu­mab is a human IgG kappa mono­clonal anti­body that can be detected on both the serum protein electrophoresis (SPE) and immuno­fix­a­tion (IFE) assays used for the clin­i­cal monitoring of endogenous M-protein. This inter­fer­ence can impact the deter­mi­na­tion of com­plete re­sponse­ and of dis­ease pro­gres­sion in some patients with IgG kappa myeloma protein.

Adverse Reactions – The most frequently reported adverse reac­tions (incidence ≥20%) were: in­fusion reac­tions, neu­tro­penia, thrombo­cyto­penia, fatigue, asthenia, nausea, diarrhea, con­sti­pa­tion, de­creased appetite, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizzi­ness, insomnia, cough, dyspnea, periph­eral edema, periph­eral sensory neu­rop­athy, bronchitis, pneu­monia, and upper res­pira­tory tract in­fec­tion.

DARZALEX® in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone (DRd): The most frequent (≥20%) adverse reac­tions for newly diag­nosed or re­lapsed / re­frac­tory patients were, re­spec­tive­ly, in­fusion reac­tions (41%, 48%), diarrhea (57%, 43%), nausea (32%, 24%), fatigue (40%, 35%), pyrexia (23%, 20%), upper res­pira­tory tract in­fec­tion (52%, 65%), muscle spasms (29%, 26%), dyspnea (32%, 21%), and cough (30%, 30%). In newly diag­nosed patients, con­sti­pa­tion (41%), periph­eral edema (41%), back pain (34%), asthenia (32%), bronchitis (29%), pneu­monia (26%), periph­eral sensory neu­rop­athy (24%), and de­creased appetite (22%) were also reported. In newly diag­nosed patients, serious adverse reac­tions (≥2% com­pared to Rd) were pneu­monia (15%), bronchitis (4%), and dehydration (2%), and treat­ment-emergent Grade 3-4 hematology laboratory ab­nor­mal­i­ties (≥20%) were neu­tro­penia (56%), lymphopenia (52%), and leu­ko­penia (35%). In re­lapsed / re­frac­tory patients, serious adverse reac­tions (≥2% com­pared to Rd) were pneu­monia (12%), upper res­pira­tory tract in­fec­tion (7%), influenza (3%), and pyrexia (3%), and treat­ment-emergent Grade 3-4 hematology laboratory ab­nor­mal­i­ties (≥20%) were neu­tro­penia (53%) and lymphopenia (52%).

DARZALEX® in com­bi­na­tion with bor­tez­o­mib, mel­phalan, and pred­ni­sone (DVMP): The most frequently reported adverse reac­tions (≥20%) were upper res­pira­tory tract in­fec­tion (48%), in­fusion reac­tions (28%), and periph­eral edema (21%). Serious adverse reac­tions (≥2% com­pared to the VMP arm) were pneu­monia (11%), upper res­pira­tory tract in­fec­tion (5%), and pul­mo­nary edema (2%). Treatment-emergent Grade 3-4 hematology laboratory ab­nor­mal­i­ties (≥20%) were lymphopenia (58%), neu­tro­penia (44%), and thrombo­cyto­penia (38%).

DARZALEX® in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone (DVd): The most frequently reported adverse reac­tions (≥20%) were periph­eral sensory neu­rop­athy (47%), in­fusion reac­tions (45%), upper res­pira­tory tract in­fec­tion (44%), diarrhea (32%), cough (27%), periph­eral edema (22%), and dyspnea (21%). The over­all in­ci­dence of serious adverse reac­tions was 42%. Serious adverse reac­tions (≥2% com­pared to Vd) were upper res­pira­tory tract in­fec­tion (5%), diarrhea (2%), and atrial fibrillation (2%). Treatment-emergent Grade 3-4 hematology laboratory ab­nor­mal­i­ties (≥20%) were lymphopenia (48%) and thrombo­cyto­penia (47%).

DARZALEX® in com­bi­na­tion with bor­tez­o­mib, thalido­mide, and dexa­meth­a­sone (DVTd): The most frequent adverse reac­tions (≥20%) were in­fusion reac­tions (35%), nausea (30%), upper res­pira­tory tract in­fec­tion (27%), pyrexia (26%), and bronchitis (20%). Serious adverse reac­tions (≥2% com­pared to the VTd arm) were bronchitis (DVTd 2% vs VTd <1%) and pneu­monia (DVTd 6% vs VTd 4%). Treatment-emergent Grade 3-4 hematology laboratory ab­nor­mal­i­ties (≥20%) were lymphopenia (59%), neu­tro­penia (33%), and leu­ko­penia (24%). DARZALEX® in com­bi­na­tion with poma­lido­mide and dexa­meth­a­sone (DPd): The most frequent adverse reac­tions (>20%) were fatigue (50%), in­fusion reac­tions (50%), upper res­pira­tory tract in­fec­tion (50%), cough (43%), diarrhea (38%), con­sti­pa­tion (33%), dyspnea (33%), nausea (30%), muscle spasms (26%), back pain (25%), pyrexia (25%), insomnia (23%), arthralgia (22%), dizzi­ness (21%), and vomiting (21%). The over­all in­ci­dence of serious adverse reac­tions was 49%. Serious adverse reac­tions reported in ≥5% of patients in­cluded pneu­monia (7%). Treatment-emergent Grade 3-4 hematology laboratory ab­nor­mal­i­ties (≥20%) were neu­tro­penia (82%), lymphopenia (71%), and anemia (30%).

DARZALEX® as mono­therapy: The most frequently reported adverse reac­tions (≥20%) were in­fusion reac­tions (48%), fatigue (39%), nausea (27%), back pain (23%), pyrexia (21%), cough (21%), and upper res­pira­tory tract in­fec­tion (20%). The over­all in­ci­dence of serious adverse reac­tions was 33%. The most frequent serious adverse reac­tions were pneu­monia (6%), general physical health deterioration (3%), and pyrexia (3%). Treatment-emergent Grade 3-4 hematology laboratory ab­nor­mal­i­ties (≥20%) were lymphopenia (40%) and neu­tro­penia (20%).

Please click here to see the full Prescribing Information.

About the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson

At Janssen, we're creating a future where dis­ease is a thing of the past. We're the Pharma­ceu­tical Com­panies of Johnson & Johnson, work­ing tirelessly to make that future a reality for patients every­where by fighting sickness with science, im­prov­ing access with ingenuity, and heal­ing hope­less­ness with heart. We focus on areas of med­i­cine where we can make the biggest dif­fer­ence: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release con­tains "forward-looking state­ments" as defined in the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 re­gard­ing DARZALEX® (dara­tu­mu­mab). The reader is cautioned not to rely on these for­ward-looking state­ments. These state­ments are based on current ex­pec­ta­tions of future events. If under­lying assump­tions prove inaccurate or known or unknown risks or un­cer­tainties ma­teri­alize, actual results could vary ma­teri­ally from the ex­pec­ta­tions and pro­jec­tions of Janssen Research & Development, LLC, or any of the other Janssen Pharma­ceu­tical Com­panies and/or Johnson & Johnson. Risks and un­cer­tainties in­clude, but are not limited to: chal­lenges and un­cer­tainties in­her­ent in prod­uct re­search and devel­op­ment, in­clud­ing the un­cer­tainty of clin­i­cal success and of obtaining regu­la­tory approvals; un­cer­tainty of commercial success; manu­fac­tur­ing dif­fi­culties and delays; com­pe­ti­tion, in­clud­ing tech­no­log­i­cal ad­vances, new prod­ucts and patents attained by com­pet­i­tors; chal­lenges to patents; prod­uct efficacy or safety con­cerns resulting in prod­uct recalls or regu­la­tory action; changes in be­havior and spending patterns of purchasers of health care prod­ucts and services; changes to appli­cable laws and reg­u­la­tions, in­clud­ing global health care reforms; and trends to­ward health care cost con­tainment. A further list and descriptions of these risks, un­cer­tainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended De­cem­ber 30, 2018, in­clud­ing in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the com­pany's most recently filed Quarterly Report on Form 10-Q and the com­pany's sub­se­quent filings with the Se­cu­ri­ties and Ex­change Com­mis­sion. Copies of these filings are avail­able online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson nor Johnson & Johnson under­takes to update any for­ward-looking state­ment as a result of new in­for­ma­tion or future events or devel­op­ments.

Kyprolis® is a registered trademark of Amgen Inc.

References

1. DARZALEX® Prescribing Information, Sep­tem­ber 2019.
2. Fedele G et al. CD38 ligation in periph­eral blood mononuclear cells of myeloma patients induces release of protumorigenic il-6 and im­paired secretion of IFNγ cytokines and pro­lif­er­a­tion. Mediators Inflamm. 2013;564687.
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Source: Janssen Oncology.