PLEIADES Safety

Safety profile in combination therapy with DARZALEX FASPRO®

PLEIADES is a phase 2, multicohort, open-label trial evaluating the safety of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with DVMP in patients with newly diagnosed multiple myeloma who are ineligible for transplant (n=67), and in combination with DRd in patients with relapsed or refractory multiple myeloma (n=65).1

DRd=DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); DVMP=DARZALEX FASPRO® (D) + bortezomib (V) + melphalan (M) + prednisone (P).

Safety profile in DARZALEX FASPRO® + VMP

Adverse reactions (10%) in patients receiving DARZALEX FASPRO® in combination with bortezomib, melphalan, and prednisone (DVMP).1

Most common adverse reactions for DARZALEX FASPRO® + VMP

VMP=bortezomib (V) + melphalan (M) + prednisone (P).

aUpper respiratory tract infection includes nasopharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, tonsillitis, upper respiratory tract infection, and viral pharyngitis.

bPneumonia includes lower respiratory tract infection, lung infection, pneumocystis jirovecii pneumonia, pneumonia, and pneumonia bacterial.

cAbdominal pain includes abdominal pain and abdominal pain upper.

dFatigue includes asthenia and fatigue.

eEdema peripheral includes edema, edema peripheral, and peripheral swelling.

fCough includes cough and productive cough.

gOnly Grade 3 adverse reactions occurred.

Safety profile in DARZALEX FASPRO® + Rd

Adverse reactions (10%) in patients receiving DARZALEX FASPRO® in combination with lenalidomide and dexamethasone (DRd).1

Most common adverse reactions for DARZALEX FASPRO® + Rd

Rd=lenalidomide (R) + dexamethasone (d).

aFatigue includes asthenia and fatigue.

bUpper respiratory tract infection includes nasopharyngitis, pharyngitis, respiratory tract infection viral, rhinitis, sinusitis, upper respiratory tract infection, and upper respiratory tract infection bacterial.

cPneumonia includes lower respiratory tract infection, lung infection, and pneumonia.

dBronchitis includes bronchitis and bronchitis viral.

eDyspnea includes dyspnea and dyspnea exertional.

fCough includes cough and productive cough.

gOnly Grade 3 adverse reactions occurred.

The most common adverse reactions with combination therapy (≥20% for any combination) include fatigue, nausea, diarrhea, dyspnea, insomnia, pyrexia, cough, muscle spasms, back pain, vomiting, upper respiratory tract infection, peripheral sensory neuropathy, constipation, and pneumonia.1

Select laboratory abnormalities worsening from baseline in patients receiving DARZALEX FASPRO® combination therapy1

Laboratory abnormalities for DARZALEX FASPRO® + VMP and DARZALEX FASPRO® + Rd

DRd=DARZALEX FASPRO® (D) + lenalidomide (R) + dexamethasone (d); DVMP=DARZALEX FASPRO® (D) + bortezomib (V) + melphalan (M) + prednisone (P); Rd=lenalidomide (R) + dexamethasone (d); VMP=bortezomib (V) + melphalan (M) + prednisone (P).

aDenominator is based on the safety population treated with DVMP (n=67) and with DRd (n=65).

Review dosing schedules for DARZALEX FASPRO® in newly diagnosed multiple myeloma

Review dosing schedules for DARZALEX FASPRO® in relapsed or refractory multiple myeloma