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  5. Drug Trials Snapshots: DARZALEX
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Drug Trials Snapshots: DARZALEX

HOW TO USE THIS SNAPSHOT
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to the DARZALEX Prescribing Information

DARZALEX (daratumumab)
(Dar'-zah-lex)
Jannsen Biotech
Approval date: November 16, 2015


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

DARZALEX is a drug used to treat patients with a form of blood cancer called multiple myeloma. It is for patients who have received at least three prior treatments for their cancer.

How is this drug used?

DARZALEX is given by a healthcare provider as an infusion into a vein. It is given according to a specific schedule.

What are the benefits of this drug?

In two trials, DARZALEX reduced the number of cancer cells or the amount of cancer in the body, also called tumor burden. In one trial, 29% of patients had a partial or complete reduction in their tumor burden, which lasted for an average of 7.4 months. In the second trial, 36% of patients had a partial or complete reduction in their tumor burden.

What are the benefits of this drug (results of trials used to assess efficacy)?

Table 2. Efficacy Results for Trial 1

  N=106
Overall response rate (ORR)
95% CI (%)
31 (29.2%)
(20.8, 38.9)
  Stringent complete response (sCR) 3 (2.8%)
  Complete response (CR) 0
  Very good partial response (VGPR) 10 (9.4%)
  Partial response (PR) 18 (17.0%)

>ORR = sCR+CR+VGPR+PR
CI = confidence interval

In the second trial, Overall response rate was 36% (95% CI: 21.6, 52.0%) with 1 CR and 3 VGPR. The median time to response was 1 month (range: 0.5 to 3.2 months). The median duration of response was not estimable (range: 2.2 to 13.1+ months).

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

Subgroup analyses were conducted for sex, race and age.

  • Sex: DARZALEX was similarly effective in men and women.
  • Race: Most patients in the trials were white. Differences in response to DARZALEX among races could not be determined.
  • Age: DARZALEX was similarly effective in patients below and above 65 years of age.

Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?

The figure below depicts the subgroup analyses for the larger trial done in 106 patients.

Figure 4. Trial 1 Subgroup Analyses on Objective Response Rates based on IRC Assessment; All Treated – 16 mg/kg Group

Figure depicts the subgroup analyses for the larger trial done in 106 patients

IRC=independent review committee

FDA Review

What are the possible side effects?

The most common side effects of DARZALEX were reactions related to the infusion of the drug, fatigue, nausea, back pain, fever and cough. DARZALEX may also result in low counts of infection-fighting white blood cells (lymphopenia, neutropenia, and leukopenia) or red blood cells (anemia) and low levels of blood platelets (thrombocytopenia).

What are the possible side effects?

The table below summarizes adverse events in the two clinical trials.

Table 3. Adverse reactions with incidence ≥10% in patients with multiple myeloma treated with DARZALEX 16 mg/kg

System Organ Class DARZALEX 16 mg/kg
N=156
Incidence (%)
Adverse Reaction Any Grade Grade 3 Grade 4
Infusion reactiona 48 3 0
General disorders and administration site conditions
Fatigue 39 2 0
Pyrexia 21 1 0
Chills 10 0 0
Respiratory, thoracic and mediastinal disorders
Cough 21 0 0
Nasal congestion 17 0 0
Dyspnea 15 1 0
Musculoskeletal and connective tissue disorders
Back pain 23 2 0
Arthralgia 17 0 0
Pain in extremity 15 1 0
Musculoskeletal chest pain 12 1 0
Infections and infestations
Upper respiratory tract infection 20 1 0
Nasopharyngitis 15 0 0
Pneumoniab 11 6 0
Gastrointestinal disorders
Nausea 27 0 0
Diarrhea 16 1 0
Constipation 15 0 0
Vomiting 14 0 0
Metabolism and nutrition disorders
Decreased appetite 15 1 0
Nervous system disorders
Headache 12 1 0
Vascular disorders
Hypertension 10 5 0/td>

a Infusion reaction includes terms determined by investigators to be related to infusion, see below
b Pneumonia also includes the terms streptococcal pneumonia and lobar pneumonia

DARZALEX Prescribing Information

Were there any differences in side effects among sex, race and age?

Subgroup analyses were conducted for sex, race and age.

  • Sex: The risk of side effects was similar in men and women.
  • Race: Most patients in the trials were white. Differences in side effects among races could not be determined.
  • Age: The risk of side effects was similar in patients below and above 65 years of age.

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

The table below summarizes subgroup analysis of treatment-emergent adverse events for the Safety Population in the clinical trials.

Table 4. Subgroup Analyses on Overview of Treatment-Emergent Adverse Events for the Pooled Population

  N TEAE Serious TEAE
Sex
  Male
  Female
 84
72
  82 (97.6%)
72 (100%)
  24 (28.6%)
26 (36.1%)
Race
  White
  Other
119
37
  117 (98.3%)
37 (100%)
  40 (33.6%)
10 (27%)
Age
  18 to <65 years
  65 to 74 years
  75 and above
 86
54
16
86 (100%)
52 (96.3%)
16 (100%)
  26 (30.2%)
20 (37%)
4 (25%)

TEAE-treatment-emergent adverse event

Clinical Trial Data

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the trials?

The FDA approved DARZALEX based primarily on evidence from 2 clinical trials in 156 patients with multiple myeloma who had received prior treatments. The trials were done in the United States, Canada, Europe, and Japan.

Figure 1 summarizes how many men and women were enrolled in the clinical trials.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were enrolled in the clinical trial used to evaluate efficacy of the drug DARZALEX.  In total, 84 men (54%) and 72 women (46%) participated in the clinical trial used to evaluate efficacy of the drug DARZALEX.

Clinical Trial Data

Figure 2 and Table 1 summarize the percentage of patients by race enrolled in the clinical trials.

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the DARZALEX clinical trial. In total, 119 Whites (76%), 16 Black or African Americans (10%), 9 Asians (6%), and 12 not collected (8%) participated in the clinical trial.

Clinical Trial Data

Table 1. Demographics of Efficacy Trials by Race

Race Number of Patients Percentage
White 119 76%
Black or African American 16 10%
Asian 9 6%
Not Collected 12 8%

Clinical Trial Data

The Figure below summarizes the perentage of patients by age in the clinical trials.

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many individuals of certain age groups were enrolled in the DARZALEX clinical trial.  In total, 86 participants were below 65 years old (55%) and 70 participants were 65 and older (45%).

Clinical Trial Data

Who participated in the trials?

The table below summarizes demographics for patients in the pooled clinical trials.

Table 5. Demographics for the Patients in the Two Pooled Clinical Trials

  Total
N=156
Demographic Subgroup
Sex, n (%)  
  Male 84 (54)
  Female 72 (46)
Age Group, n (%)
18- <65 years 86 (55)
≥65 - <75 years 54 (35)
  >=75 years 16 (10)
Race, n (%)
  White 119 (76)
  Black or African American 16 (10)
  Asian 9 (5.8)
  Other, unknown, and unreported 12 (7.7)
Ethnicity, n (%)
  Hispanic or Latino 10 (6)
  Not Hispanic or Latino 135 (87)
  Unknown 11 (7)

Clinical Trial Data

How were the trials designed?

Two trials were conducted in which all patients received DARZALEX. Treatment was continued until there were unacceptable side effects or the cancer progressed.

How were the trials designed?

Trial 1 was an open-label trial evaluating DARZALEX monotherapy in patients with relapsed or refractory multiple myeloma who had received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who were double-refractory to a proteasome inhibitor and an immunomodulatory agent. In 106 patients, DARZALEX 16 mg/kg was administered with pre- and post-infusion medication. Treatment continued until unacceptable toxicity or disease progression.

Trial 2 was an open-label dose escalation trial evaluating DARZALEX monotherapy in patients with relapsed or refractory multiple myeloma who had received at least 2 different cytoreductive therapies. In 42 patients, DARZALEX 16 mg/kg was administered with pre- and post-infusion medication. Treatment continued until unacceptable toxicity or disease progression.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.

PRESCRIBING INFORMATION

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