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  1. Development & Approval Process (Drugs)

Drug Trials Snapshot: VIZIMPRO

Drug Trials Snapshot: VIZIMPRO

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 VIZIMPRO Prescribing Information for complete information.

VIZIMPRO (dacomitinib)
vih-ZIM-pro
Pfizer
Approval date: September 27, 2018


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

VIZIMPRO is a drug used to treat patients with a type of lung cancer called advanced non-small cell lung cancer (NSCLC). It is to be used as a first treatment in patients whose cancer has spread to other parts of the body (metastatic) and has certain types of gene mutation.

How is this drug used?

VIZIMPRO is a tablet taken by mouth once a day.

What are the benefits of this drug?

Patients who were treated with VIZIMPRO lived about 15 months without disease progression in comparison to patients who receved comparator drug gefitinib who lived about 9 months without disease progression.

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

Efficacy results from the trial are summarized below. The major efficacy outcome measure was progression-free survival (PFS) as determined by blinded Independent Radiologic Central (IRC) review per RECIST v1.1. Additional efficacy outcome measures were overall response rate (ORR), duration of response (DoR), and overall survival (OS).

Table 2. Efficacy Results

 

VIZIMPRO
N=227

Gefitinib
N=225

Progression-Free Survival (per IRC)

          Number of patients with event, n

136 (59.9%)

179 (79.6%)

          Median PFS in months (95% CI)

14.7 (11.1, 16.6)

9.2 (9.1, 11.0)

          HR (95% CI)a

0.59 (0.47, 0.74)

          p-valueb

<0.0001

Overall Response Rate (per IRC)

        Overall Response Rate % (95% CI)

75% (69, 80)

72% (65, 77)

         p-valuec

0.39

Duration of Response in Responders (per IRC)

         Median DoR in months (95% CI)

14.8 (12.0, 17.4)

8.3 (7.4, 9.2)

CI=confidence interval; DoR=duration of response; HR=hazard ratio; IRC=Independent Radiologic Central; N/n=total number; PFS=progression-free survival.
    a. From stratified Cox Regression
    b. Based on the stratified log-rank test.
    c. Based on the stratified Cochran-Mantel-Haenszel test

VIZIMPRO Prescribing Information

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

  • Sex: VIZIMPRO worked similarly in men and women.
  • Race: The majority of patients were Asians. Therefore, differences in how well the drug work among races could not be determined.
  • Age: VIZIMPRO worked similarly 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?

Efficacy subgroup analyses are summarized below.

Table 3. PFS Subgroup Analyses

 

PFS Events / N

Medians

HR (95% CI)

 

VIZIMPRO

Gefitinib

VIZIMPRO

Gefitinib

  PFS, ITT

136/227

179/225

14.7

9.2

0.59 (0.47, 0.74)

Sex

  Men

54/81

77/100

12.3

9.2

0.70 (0.49, 1.01)

  Women

82/146

102/125

14.8

9.2

0.50 (0.37, 0.68)

Race

  Asian

97/170

140/176

16.5

9.3

0.51 (0.39, 0.67)

  White

38/56

39/49

10.8

9.2

0.80 (0.51, 1.26)

  Chinese

67/115

95/119

16.0

9.2

0.50 (0.36, 0.68)

  Japanese

22/40

31/41

18.2

9.3

0.54 (0.30, 0.95)

  Other East Asian

8/15

14/17

16.5

12.7

0.67 (0.27, 1.67)

  Non-East Asian

39/57

39/48

9.3

9.2

0.83 (0.53, 1.30)

Age

  < 65 years

83/133

114/140

16.0

9.2

0.55 (0.41, 0.74)

   >= 65 years

53/94

65/85

11.3

9.2

0.60 (0.40, 0.89)

FDA Review

What are the possible side effects?

VIZIMPRO may cause serious side effects including inflammation of the lungs, severe diarrhea, and skin reactions.

The most common side effects of VIZIMPRO are diarrhea, rash, nail infection, mouth sores, decreased appetite, dry skin, decreased weight, hair loss, caugh and skin itching.

What are the possible side effects (results of trials used to assess safety)?

The table below summarizes adverse reactions that occurred during the trial.

Table 4. Adverse Reactions Occurring in ≥10% of Patients Receiving VIZIMPRO*

Adverse Reaction

VIZIMPRO
(N=227)

Gefitinib
(N=224)

All Gradesa
%

Grades 3 and 4
%

All Grades
%

Grades 3 and 4
%

Gastrointestinal

Diarrheab

87

8

56

0.9

Stomatitisc

45

4.4

19

0.4

Nausea

19

1.3

22

0.4

Constipation

13

0

14

0

Mouth ulceration

12

0

6

0

Skin and Subcutaneous Tissue

Rashd

69

23

47

0.4

Paronychiae

64

8

21

1.3

Dry skinf

30

1.8

19

0.4

Alopecia

23

0.4

13

0

Pruritusg

21

0.9

15

1.3

Palmar-plantar erythrodysesthesia syndrome

15

0.9

3.1

0

Dermatitis

11

1.8

4

0.4

Metabolism and Nutrition

Decreased appetite

31

3.1

25

0.4

Decreased weight

26

2.2

17

0.4

Respiratory

Cough

21

0

19

0.4

Nasal mucosal disorderh

19

0

4.9

0

Dyspnea

13

2.2

13

1.8

Upper respiratory tract infection

12

1.3

13

0

Chest pain

10

0

14

0

Eye

Conjunctivitis

19

0

4

0

Musculoskeletal

Pain in extremity

14

0

12

0

Musculoskeletal pain

12

0.9

13

0

General

Asthenia

13

2.2

13

1.3

Psychiatric

Insomnia

11

0.4

15

0

* National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
a Grades 1 through 5 are included in All Grades.
b One Grade 5 (fatal) event in the VIZIMPRO arm.
c Stomatitis includes mucosal inflammation and stomatitis.
d Rash includes dermatitis acneiform, rash, and rash maculo-papular.
e Paronychia includes nail infection, nail toxicity, onychoclasis, onycholysis, onychomadesis, paronychia.
f Dry skin includes dry skin, xerosis.
g Pruritus includes pruritus, pruritus generalized, rash pruritic.
h Nasal mucosal disorder includes epistaxis, nasal inflammation, nasal mucosal disorder, nasal mucosal ulcer, rhinitis.

VIZIMPRO Prescribing Information

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

  • Sex: The occurrence of side effects was similar in men and women.
  • Race: The majority patients in the clinical trial were Asians. Differences in occurrence of side effects among races could not be determined.
  • Age: The occurrence of side effect 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 tables below summarize occurrence of two most common adverse reactions in VIZIMPRO treated patients by subgroups.

Table 5. Adverse Reactions by Sex

Adverse Reactions

Men
(N=81)

Women
(N=146)

All Grades

 

Grade 3

 

Grade 4

 

All Grades

 

Grade 3

 

Grade 4

Diarrhea

84%

6%

0%

89%

10%

0%

Rash

75%

16%

0%

84%

30%

0%

Table 6. Adverse Reactions by Race

Adverse Reactions

Asian
(N=170)

All Other
(N=57)

All Grades

 

Grade 3

 

Grade 4

 

All Grades

 

Grade 3

 

Grade 4

 

Diarrhea

 91%

7%

0%

 77%

 12%

0%

Rash

82%

25%

0%

79%

26%

0%

Table 7. Adverse Reactions by Age

Adverse Reactions

<= 65 yeras
(N=138)

> 65 years
(N=89)

All Grades

 

Grade 3

 

Grade 4

 

All Grades

 

Grade 3

 

Grade 4

 

Diarrhea

88%

7%

0%

85%

10%

0%

Rash

83%

24%

0%

79%

27%

0%

Adapted from FDA Review

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved VIZIMPRO based on evidence from one clinical trial (NCT01774721) with a total of 452 patients with advanced non-small cell lung cancer. Trial was conducted in Asia.

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

Figure 1. Baseline Demographics by Sex
 

Missing media.
FDA Review

 

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

Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of patients by race enrolled in the trial. In total, 346 Asians (77%), 105 Whites (23%), and 1 Black (&lt;1%), participated in the clinical trial.
FDA Review

Table 1. Baseline Demographics by Race

Race

Number of Patients

Percentage

White

105

23

Black or African American

1

less than 1

Asian

346

77

FDA Review

The figure below summarizes how many patients by age group were enrolled in the clinical trial.

Figure 3. Baseline Demographics by Age

​Pie charts summarizing how many individuals of certain age groups were in the clinical trial. In total, 273 were below 65 years old (60%) and 179 participants were 65 and older (40%).
FDA Review

Who participated in the trials?

The table below summarizes demographic characteristics of trial population.

Table 8. Trial Demographics

Demographic Characteristic

  VIZIMPRO (N=227)

Gefitinib (N=225)

Total (N=452)

Sex, n (%)

    Men

81 (35.7)

100 (44.4)

181 (40.1)

    Women

146 (64.3)

125 (55.6)

271(59.9)

Race, n (%)

     Asian

170 (74.9)

176 (78.2)

346 (76.5)

    White

56 (24.7)

49 (21.8)

105 (23.2)

    Black or African American

1 (0.4)

0

1(<1)

Age Group, n (%)

    Age <65 years

133 (58.6)

140 (62.2)

273 (60.4)

    Age ≥65 years

94 (41.4)

85 (37.8)

179 (39.6)

Ethnicity, n (%)

    Hispanic or Latino

0

0

0

    Not Hispanic or Latino

227 (100%)

225 (100%)

452 (100%)

Region, n (%)

    Japan

40 (17.6)

41 (18.2)

81(17.9)

    Mainland Chinese

115 (50.7)

119 (52.9)

234 (51.7)

    Non-East Asian

57 (25.1)

48 (21.3)

105 (23.2)

    Other East Asian

15 (6.6)

17 (7.6)

32 (7.1)

FDA Review

How were the trials designed?

The benefits and side effects of VIZIMPRO were evaluated in one clinical trial.

Enrolled patients had a type of non-small cell lung cancer (NSCLC) that contains specific epidermal growth factor receptor mutations. Patients either never received any chemotherapy treatment for their cancer or the cancer came back after completion of previous chemotherapy treatment.

Patients were treated with either VIZIMPRO or gefitinib (an approved drug for treatment of NSCLC) until either disease progresion or developmet of intolerable side effects.

The benefit of VIZIMPRO in comparison to gefitinimib was assessed by the length of time that patients lived without disease progression (progression free survival or PFS).

How were the trials designed?

The efficacy and safety of VIZIMPRO were demonstrated in a randomized, multicenter, multinational, open-label trial. Enrolled patients had unresectable, metastatic NSCLC with no prior systemic therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy. EGFR mutation status was prospectively determined.

Patients were randomized (1:1) to receive VIZIMPRO 45 mg orally once daily or gefitinib 250 mg orally once daily until disease progression or unacceptable toxicity.

The major efficacy outcome measure was progression-free survival (PFS) as determined by blinded Independent Radiologic Central (IRC) review per RECIST v1.1. Additional efficacy outcome measures were overall response rate (ORR), duration of response (DoR), and overall survival (OS).

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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