ACN_7.14_Full Issue digital | Page 35

SPOTLIGHT to make sure these topics continue to be part of the conversation at the annual meeting .

What topics will the speakers be discussing in their presentations ? Dr . Weeks : My co-chair , Wally Smith , MD , and I thought it was important to go back to the basic principles of racial equity and its implications on hematology research . We invited two dynamic speakers to discuss these topics . Deirdra Terrell , PhD , co-chair of ASH ’ s Committee on Promoting Diversity , will discuss the construct of race : What is it race ? Is it a genetic , biologic , or social construct ? Her goal is to be descriptive about what race is as a variable and what it is not . Dr . Barabino , who is also a member of the Committee on Promoting Diversity and a thought leader on the topic of race , ethnicity , and gender in science , was invited to discuss the implications of racial biases in hematology research .

How is racial bias evident in medical science – from design of trials to the ideas of race as a genetic or biologic construct ? Dr . Barabino : I plan to address this in my presentation , with a discussion of the roots of racial bias in medicine and the myriad ways it plays out in

DARZALEX FASPRO ^® ( daratumumab and hyaluronidase-fihj ) injection

Monotherapy The safety of DARZALEX FASPRO as monotherapy was evaluated in COLUMBA [ see Clinical Trials ( 14.2 ) in Full Prescribing Information ]. Patients received DARZALEX FASPRO 1,800 mg / 30,000 units administered subcutaneously or daratumumab 16 mg / kg administered intravenously ; each administered once weekly from weeks 1 to 8 , once every 2 weeks from weeks 9 to 24 and once every 4 weeks starting with week 25 until disease progression or unacceptable toxicity . Among patients receiving DARZALEX FASPRO , 37 % were exposed for 6 months or longer and 1 % were exposed for greater than one year .

Serious adverse reactions occurred in 26 % of patients who received DARZALEX FASPRO . Fatal adverse reactions occurred in 5 % of patients . Fatal adverse reactions occurring in more than 1 patient were general physical health deterioration , septic shock , and respiratory failure .

Permanent discontinuation due to an adverse reaction occurred in 10 % of patients who received DARZALEX FASPRO . Adverse reactions resulting in permanent discontinuation of DARZALEX FASPRO in more than 2 patients were thrombocytopenia and hypercalcemia .

Dosage interruptions due to an adverse reaction occurred in 26 % of patients who received DARZALEX FASPRO . Adverse reactions requiring dosage interruption in > 5 % of patients included thrombocytopenia .

The most common adverse reaction ( ≥20 %) was upper respiratory tract infection . Table 7 summarizes the adverse reactions in COLUMBA .

Table 7 : Adverse Reactions ( ≥10 %) in Patients Who Received DARZALEX FASPRO or Intravenous Daratumumab in COLUMBA

DARZALEX FASPRO Intravenous Daratumumab ( N = 260 )

( N = 258 )

All Grades (%)

Grade ≥3 (%)

All Grades (%)

Grade ≥3 (%)

a Upper respiratory tract infection includes acute sinusitis , nasopharyngitis ,

pharyngitis , respiratory syncytial virus infection , respiratory tract infection , rhinitis , rhinovirus infection , sinusitis , and upper respiratory tract infection . b Pneumonia includes lower respiratory tract infection , lung infection ,

pneumocystis jirovecii pneumonia , and pneumonia . c Fatigue includes asthenia , and fatigue .

d Infusion reactions includes terms determined by investigators to be related to infusion . e Cough includes cough , and productive cough .

f Dyspnea includes dyspnea , and dyspnea exertional .

# Only grade 3 adverse reactions occurred .

@ Grade 5 adverse reactions occurred .

Clinically relevant adverse reactions in < 10 % of patients who received DARZALEX FASPRO included :

• General disorders and administration site conditions : injection site reaction , peripheral edema

• Musculoskeletal and connective tissue disorders : arthralgia , musculoskeletal chest pain , muscle spasms

• Gastrointestinal disorders : constipation , vomiting , abdominal pain

• Metabolism and nutrition disorders : decreased appetite , hyperglycemia , hypocalcemia , dehydration

• Psychiatric disorders : insomnia

• Vascular disorders : hypertension , hypotension

• Nervous system disorders : dizziness , peripheral sensory neuropathy , paresthesia

• Infections : bronchitis , influenza , urinary tract infection , herpes zoster , sepsis , hepatitis B virus reactivation

• Skin and subcutaneous tissue disorders : pruritus , rash

• Cardiac disorders : atrial fibrillation

• Respiratory , thoracic and mediastinal disorders : pulmonary edema

DARZALEX FASPRO ^® ( daratumumab and hyaluronidase-fihj ) injection

Table 8 summarizes the laboratory abnormalities in COLUMBA .

Table 8 : Select Hematology Laboratory Abnormalities Worsening from Baseline in Patients Receiving DARZALEX FASPRO or Intravenous Daratumumab in COLUMBA

DARZALEX Intravenous

FASPRO ^a

Daratumumab ^a

All Grades (%)

Grades 3-4 (%)

All Grades (%)

Grades 3-4 (%)

a Denominator is based on the safety population treated with DARZALEX FASPRO ( N = 260 ) and Intravenous Daratumumab ( N = 258 ).

Light Chain Amyloidosis In Combination with Bortezomib , Cyclophosphamide and Dexamethasone

The safety of DARZALEX FASPRO with bortezomib , cyclophosphamide and dexamethasone ( DARZALEX FASPRO-VCd ) was evaluated in ANDROMEDA [ see Clinical Studies ( 14.2 ) in Full Prescribing Information ]. Patients received DARZALEX FASPRO 1,800 mg / 30,000 units administered subcutaneously once weekly from weeks 1 to 8 , once every 2 weeks from weeks 9 to 24 and once every 4 weeks starting with week 25 until disease progression or unacceptable toxicity or a maximum of 2 years . Among patients who received DARZALEX FASPRO-VCd , 74 % were exposed for 6 months or longer and 32 % were exposed for greater than one year .

Serious adverse reactions occurred in 43 % of patients who received DARZALEX FASPRO in combination with VCd . Serious adverse reactions that occurred in at least 5 % of patients in the DARZALEX FASPRO-VCd arm were pneumonia ( 9 %), cardiac failure ( 8 %), and sepsis ( 5 %). Fatal adverse reactions occurred in 11 % of patients . Fatal adverse reactions that occurred in more than one patient included cardiac arrest ( 4 %), sudden death ( 3 %), cardiac failure ( 3 %), and sepsis ( 1 %).

Permanent discontinuation of DARZALEX FASPRO due to an adverse reaction occurred in 5 % of patients . Adverse reactions resulting in permanent discontinuation of DARZALEX FASPRO in more than one patient were pneumonia , sepsis , and cardiac failure .

Dosage interruptions ( defined as dose delays or skipped doses ) due to an adverse reaction occurred in 36 % of patients who received DARZALEX FASPRO . Adverse reactions which required a dosage interruption in ≥3 % of patients included upper respiratory tract infection ( 9 %), pneumonia ( 6 %), cardiac failure ( 4 %), fatigue ( 3 %), herpes zoster ( 3 %), dyspnea ( 3 %), and neutropenia ( 3 %).

The most common adverse reactions ( ≥20 %) were upper respiratory tract infection , diarrhea , peripheral edema , constipation , fatigue , peripheral sensory neuropathy , nausea , insomnia , dyspnea , and cough .

Table 9 below summarizes the adverse reactions in patients who received DARZALEX FASPRO in ANDROMEDA .

Table 9 : Adverse Reactions ( ≥10 %) in Patients with AL Amyloidosis Who Received DARZALEX FASPRO with Bortezomib , Cyclophosphamide and Dexamethasone ( DARZALEX FASPRO-VCd ) with a Difference Between Arms of > 5 % Compared to VCd in ANDROMEDA

DARZALEX FASPRO-VCd VCd

( N = 193 ) ( N = 188 )

All Grades (%)

Grades 3-4 (%)

All Grades (%)

Grades 3-4 (%)