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  5. Drug Trials Snapshot: GEMTESA
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Drug Trials Snapshot: GEMTESA

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 GEMTESA Package Insert for complete information.

GEMTESA (vibegron)
gem tes' ah
Urovant Sciences, Inc.
Approval date: December 23, 2020


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

GEMTESA is used treat the following symptoms due to a condition called overactive bladder (OAB):

  • a strong need to urinate with leaking or wetting accidents,
  • the need to urinate right away, and
  • the need to urinate often.

How is this drug used?

GEMTESA is a tablet taken my mouth once a day.

What are the benefits of this drug?

After 12 weeks of treatment, patients who received GEMTESA experienced reduced number of OAB related symptoms in comparison to patients who received placebo.

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

The table below summarizes efficacy results for the evaluated patients. The primary efficacy endpoints were change from baseline in average daily number of micturitions (urinations) and average daily number of urge urinary incontinence (UUI) episodes (need to urinate with leaking or wetting accidents) at week 12. Additional secondary endpoints included change from baseline in average daily number of “need to urinate immediately” (urgency) episodes and average volume voided per micturition.

Table 1. Mean Baseline and Change from Baseline at Week 12 for Micturition Frequency, Urge Urinary Incontinence Episodes, “Need to Urinate Immediately” (Urgency) Episodes, and Volume Voided per Micturition

Parameter

GEMTESA

Placebo

Average Daily Number of Micturitions

    Baseline mean (n)

11.3 (526)

11.8 (520)

    Change from Baseline* (n)

-1.8 (492)

-1.3 (475)

    Difference from Placebo

-0.5

    95% Confidence Interval

-0.8, -0.2

    p-value

<0.001

Average Daily Number of UUI Episodes

    Baseline mean (n)

3.4 (403)

3.5 (405)

    Change from Baseline* (n)

-2.0 (383)

-1.4 (372)

    Difference from Placebo

-0.6

95% Confidence Interval

-0.9, -0.3

    p-value

<0.0001

Average Daily Number of “Need to Urinate Immediately” (Urgency) Episodes

    Baseline mean (n)

8.1 (526)

8.1 (520)

    Change from Baseline□ (n)

-2.7 (492)

-2.0 (475)

    Difference from Placebo

-0.7

    95% Confidence Interval

-1.1, -0.2

    p-value

0.002

Average Volume Voided (mL) per Micturition

    Baseline mean (n)

155 (524)

148 (514)

    Change from Baseline□ (n)

23 (490)

2 (478)

    Difference from Placebo

21

    95% Confidence Interval

14, 28

    p-value

<0.0001

*Least squares mean adjusted for treatment, baseline, sex, geographical region, study visit, and study visit by treatment interaction term.

GEMTESA Prescribing Information

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

  • Sex: The majority of patients were women, therefore the differences in how well the drug worked between men and women could not be determined.
  • Race: The majority of patients were White, therefore the differences in how well the drug worked among races could not be determined.
  • Age: GEMTESA worked similarly in patients younger than and older than 65 years of age.

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

The figures below summarize efficacy results by demographic subgroups for two endpoints: average daily number of micturitions (urinations) and UUI episodes. Given the descriptive nature of these analyses and the smaller size of the subgroups, these findings should be interpreted with caution.

Figure 5. Forest Plot of GEMTESA Treatment Effect vs Placebo on Average Daily Number of Micturitions at Week 12 by Subgroup

Table summarizes primary efficacy results by sex, race and age subgroups.

Figure 6. Forest Plot of GEMTESA Treatment Effect vs Placebo on Average Daily Number of UUI Episodes at Week 12 by Subgroup

Table summarizes primary efficacy results by sex, race and age subgroups.

FDA Statistical Review

What are the possible side effects?

GEMTESA may cause serious side effects including inability to empty bladder (urinary retention).

The most common side effect of GEMTESA are headache, urinary tract infection, common cold, diarrhea, nausea, and upper respiratory tract infection.

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

Presented below are common adverse reactions that were reported in the trial.

Table 2. Adverse Reactions, Exceeding Placebo Rate, Reported in ≥2% of Patients Treated with GEMTESA for up to 12 Weeks

 

GEMTESA
n (%)

Placebo
n (%)

Number of Patients

545

540

Headache

22 (4.0)

13 (2.4)

Nasopharyngitis

15 (2.8)

9 (1.7)

Diarrhea

12 (2.2)

6 (1.1)

Nausea

12 (2.2)

6 (1.1)

Upper respiratory tract infection

11 (2.0)

4 (0.7)

GEMTESA Prescribing Information

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

  • Sex: The occurrence of side effects between men and women was similar.
  • Race The occurrence of side effects was similar among tested races.
  • Age: The occurrence of side effects was similar between patients younger than and older than 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 the occurrence of the most common adverse reactions, by sex, race and age subgroups. Presented is the pooled safety population from two placebo-controlled Phase 3 trials where GEMTESA was used for 12 weeks at the approved dose.

Table 3. Subgroup Analysis of Common Adverse Reactions by Sex

 

GEMTESA
n (%)

Placebo
n (%)

Men

N =82

N =117

Any AE

29 (35)

29 (25)

Diarrhea

3 (4)

0

Headache

2 (2)

1 (1)

Nausea

1 (1)

1 (1)

Nasopharyngitis

0

1 (1)

 

Women

N =463

N =792

Any AE

182 (39)

252 (32)

Urinary tract infection

26 (6)

32 (4)

Headache

20 (4)

12 (2)

Nasopharyngitis

15 (3)

35 (4)

Nausea

11 (2)

5 (1)

Diarrhea

9 (2)

10 (1)

Table 4. Subgroup Analysis of Common Adverse Reactions by Race

 

GEMTESA
n (%)

Placebo
n (%)

White

N =453

N =418

Any AE

174 (40)

144 (34)

Urinary tract infection

23 (5)

28 (7)

Headache

13 (3)

13 (3)

Nasopharyngitis

14 (3)

9 (2)

Nausea

11 (3)

4 (1)

Diarrhea

12 (3)

5 (1)

 

Black or African American

N =78

N =85

Any AE

19 (24)

20 (24)

Urinary tract infection

3 (4)

4 (5)

Headache

2 (3)

0

Upper respiratory tract infection

2 (3)

0

 

Asian

N =28

N =399

Any AE

15 (54)

115 (29)

Headache

6 (21)

0

Nausea

1 (4)

2 (1)

Urinary tract infection

1 (4)

1 (<1)

Nasopharyngitis

0

27 (7)

Table 5. Subgroup Analysis of Common Adverse Reactions by Age

 

GEMTESA
n (%)

Placebo
n (%)

< 65 Years

N =299

N =550

Any AE

101 (33.8)

144 (26.2)

Urinary tract infection

13 (4.3)

15 (2.7)

Headache

11 (3.7)

8 (1.5)

Nasopharyngitis

9 (3.0)

17 (3.1)

Nausea

7 (2.3)

3 (0.5)

Diarrhea

6 (2.0)

6 (1.1)

 

≥ 65 Years

N =246

N =359

Any AE

110 (44.7)

137 (38.2)

Urinary tract infection

14 (5.7)

18 (5.0)

Headache

11 (4.5)

5 (1.4)

Upper respiratory tract infection

8 (3.3)

2 (0.6)

Diarrhea

6 (2.4)

4 (1.1)

Nasopharyngitis

6 (2.4)

19 (5.3)

Clinical Trial Data

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved GEMTESA based on evidence from one clinical trial (Trial 1/ NCT03492281) of 1085 adult patients 18 to 93 years old with OAB. The trial was conducted at 199 sites in the United States, Canada, Poland Hungary, Latvia, and Lithuania.

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

Figure 1. Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trials.  In total, 163 men (15%) and 922 women (85%) participated in the clinical trial.

Adapted from FDA Review

Figure 2 summarizes the percentage of patients by race in the clinical trial.

Figure 2. Demographics by Race

Pie chart summarizing how many patients of different races were in the clinical trial.  In total, 853 patients were White (79%), 58 patients were Asian (5%), 163 patients were Black or African American (15%), and 11 patients were Other (1%).

*includes Other and American Indian or Alaska Native
Adapted from FDA Review

Figure 3 summarizes the percentage of patients by age in the clinical trial.

Figure 3. Demographics by Age

Pie chart summarizing how many individuals of certain age groups were in the clinical trial.  In total, 611 patients were between 18-64 years old (56%), 339 patients were between 65-74 years old (31%), and 135 patients were 75 year and older (13%).

Adapted from FDA Review

Figure 4 summarizes the percentage of patients by ethnicity in the clinical trial.

Figure 4. Demographics by Ethnicity

Pie chart summarizing how many individuals of certain ethnicity groups were in the clinical trial.  In total, 294 patients were Hispanic or Latino (27%), and 790 patients were not Hispanic or Latino (73%).

Adapted from FDA Review

Who participated in the trials?

The table below summarizes demographics of the population in the Phase 3 clinical trial (Trial 1/ NCT03492281).

Table 6. Baseline Demographics (safety population)

 

 

GEMTESA
N = 545

 

Placebo
N = 540

 

TOTAL
N = 1085

Sex, n (%)

    Men

82 (15)

81 (15)

163 (15)

    Women

463 (85)

459 (85)

922 (85)

Race, n (%)

    American Indian or Alaska Native

2 (<1)

3 (1)

5 (<1)

    Asian

28 (5)

30 (6)

58 (5)

    Black or African American

78 (14)

85 (16)

163 (15)

    White

435 (80)

418 (77)

853 (79)

    Other

2 (<1)

4 (1)

6 (<1)

Age (years)

    Median (Min, Max)

63 (18,93)

61 (19,89)

62 (18,93)

Age Group (years), n (%)

    18 to < 65

299 (55)

312 (58)

611 (56)

    ≥ 65 to < 75

171 (31)

168 (31)

339 (31)

    ≥ 75

75 (14)

60 (11)

135 (13)

  Ethnicity

    Hispanic or Latino

152 (28)

142 (26)

294 (73)

    Not Hispanic or Latino

392 (72)

398 (74)

790 (27)

    Missing

1 (<1)

0

1 (<1)

Region, n (%)

    US

490 (90)

483 (89)

973 (90)

    Non-US

55 (10)

57 (11)

112 (10)

Adapted from FDA Review

How were the trials designed?

The benefit and side effects of GEMTESA were evaluated in one clinical trial which enrolled adult patients with OAB. Some patients were previously treated for the symptoms of OAB, and some were never treated before.

Patients received once daily treatment with either GEMTESA, placebo, or active control. Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed. Patients were keeping a dairy of daily OAB symptoms.

The benefit of GEMTESA in comparison to placebo was assessed after 12 weeks by comparing the change from baseline in average daily number of voiding and average daily number of leaking accidents.

How were the trials designed?

The safety and efficacy of GEMTESA were established in one 12-week, double-blind, randomized, placebo-controlled, and active-controlled trial in patients with OAB (urge urinary incontinence, urgency, and urinary frequency). The trial population included OAB medication-naïve patients as well as patients who had received prior therapy with OAB medications. Patients were randomized to receive either GEMTESA, placebo, or active control orally, once daily for 12 weeks.

The co-primary endpoints were change from baseline in average daily number of micturitions (urinations) and average daily number of urge urinary incontinence (UUI) episodes (“need to urinate immediately” (urgency) with leaking or wetting accidents) at week 12. Additional secondary endpoints included change from baseline in average daily number of “need to urinate immediately” (urgency) episodes and average volume voided per micturition.

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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