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Drug Trials Snapshots: Tecentriq

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 TECENTRIQ Prescribing Information for complete information.

TECENTRIQ (atezolizumab)
(te sen' trik)
Genentech Inc.
Approval date: May 18, 2016


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

TECENTRIQ is a drug for the treatment of a type of bladder cancer called urothelial carcinoma. TECENTRIQ may be used when:

  • bladder cancer has spread or cannot be removed by surgery (advanced urothelial carcinoma) and,
  • chemotherapy that contains platinum did not work or is no longer working.

How is this drug used?

TECENTRIQ is given by a health care professional into vein through an intravenous (IV) line over 30 to 60 minutes.
TECENTRIQ is usually given every 3 weeks.

What are the benefits of this drug?

About 15% of participants had partial or complete shrinkage of their tumors. Most of these responding participants are being followed to see how long the benefit will last.

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

The table below summarizes efficacy results for the clinical trial based on objective response rate (ORR) as assessed by independent review facility (IRF) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and duration of response (DoR).

Table 2. Summary of Efficacy

 All PatientsPD-L1 Expression Subgroups
 N = 310P-L1
Expression of < 5%="" in="">1
(N=210)
PD-L1
Expression of
≥ 5% in ICs1
(N=100)
Number of IRF-assessed Confirmed Responders462026
ORR % (95% CI)14.8% (11.1, 19.3)9.5% (5.9, 14.3)26.0% (17.7, 35.7)
Complete Response (CR) (%)5.5%2.4%12.0%
Partial Response (PR) (%)9.4%7.1%14.0%
Median DoR, months
(range)
NR
(2.1+, 13.8+)
12.7
(2.1+, 12.7)
NR
(4.2, 13.8+)
NR= Not reached
+ Denotes a censored value
1PD-L1 expression in tumor-infiltrating immune cells (ICs)

TECENTRIQ Prescribing Information

 

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

  • Sex: TECENTRIQ worked similarly in men and women
  • Race: The majority of participants in the clinical trials were White. Differences among races could not be determined due to small number of participants from other races.
  • Age: TECENTRIQ worked similarly in patients younger 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 table below summarizes efficacy results by subgroup

Table 3. Subgroup Analysis Based on Objective Response Rate (ORR)

ORR n/N
% (95% CI)
TECENTRIQ
(N=310)
Sex
Men40/241
16.6% (12.1%, 21.9%)
Women6/69
8.7% (3.3%, 18.0%)
Age
Age <>17/127
13.4% (8.0%, 20.6%)
Age >=6529/183
15.8% (10.9%, 22.0%)
Race
White40/282
14.2% (10.3,18.8)
Non-White6/28
21.4 % (8.3, 41.0)
Region
US28/210
13.3% (9.1%, 18.7%)
Non-US18/100
18.0% (11.0%, 27.0%)
CI: confidence interval
FDA Review

 

What are the possible side effects?

The most common side effects are feeling tired (fatigue), decreased appetite, nausea, urinary tract infection, fever, and constipation.

TECENTRIQ may cause serious side effects including infection, lung inflammation (pneumonitis), liver (hepatitis), intestine (colitis), and hormone glands injury (pituitary, thyroid, adrenal, and pancreas).

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

The table below summarizes adverse reactions that occurred in patients treated with TECENTRIQ.

Table 4. All Grade Adverse Reactions in ≥ 10% of Patients with Urothelial Carcinom

 TECENTRIQ
N = 310
Adverse ReactionAll Grades
(%)
Grades 3 – 4
(%)
All Adverse Reactions9650
Gastrointestinal Disorders
Nausea252
Constipation210.3
Diarrhea181
Abdominal pain174
Vomiting171
General Disorders and Administration
Fatigue526
Pyrexia211
Peripheral edema181
Infections and Infestations
Urinary tract infection229
 Metabolism and Nutrition Disorders
Decreased appetite261
Musculoskeletal and Connective Tissue Disorders
Back/Neck pain152
Arthralgia141
Renal and urinary disorders
Hematuria143
Respiratory, Thoracic, and Mediastinal Disorders
Dyspnea164
Cough140.3
Skin and Subcutaneous Tissue Disorders
Rash150.3
Pruritus130.3
TECENTRIQ Prescribing Information

 

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

  • Sex: The occurrence of common side effects was similar in male and female patients.
  • Race: The majority of participants in the clinical trial were White. Differences in side effects among races could not be determined due to small number of participants from other races.
  • Age: The occurrence of common side effect was similar in patients younger 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 table below summarizes adverse events by subgroup

Table 5. Grade 1-4 Adverse Events by Subgroup

Demographic Parameters            
       
                 TECENTRIQ    (N=310)                      
Percent of the Patients in the Subgroup Experiencing at Least One Adverse Event of Any Grade
Sex (N)
  Men (241)98%
  Women (69)91%
Age Group (N)
  <65 years="">96%
  65 and older (183)95%
Race (N)
  White (282)96%
  Non-White (28)96%
Clinical trial data

 


WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved TECENTRIQ based primarily on evidence from one clinical trial of 310 patients with advanced bladder cancer. The trial was conducted in the United States, Canada, Spain, France, Great Britain, Germany, Italy and Netherlands.

The figure below summarizes how many men and women were in the clinical trial.

Figure 1. Baseline Demographics by Sex

Pie chart summarizing how many men and women were in the clinical trial of the drug TECENTRIQ. In total, 241 men (78%) and 69 women (22%) participated in the clinical trial used to evaluate the drug TECENTRIQ.

Clinical trial data

Figure 2 and Table 1 below summarize the percentage of patients by race in the clinical trial.
Figure 2. Baseline Demographics by Race

Pie chart summarizing the percentage of participants by race in the TECENTRIQ clinical trial. In total, 282 Whites (91%), 6 Blacks (2%), 7 Asians (2%), and 15 Other and Unknown (5%), participated in the clinical trial.

Clinical trial data

Table 1. Baseline Demographics by Race

RaceNumber of PatientsPercentage
White28291%
Asian72%
Black or African American62%
American Indian or Alaska Native1less than 1%
Native Hawaiian or Other Pacific Islander1less than 1%
 Other72%
Unknown62%

Clinical trial data

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

Figure 3. Baseline Demographics by Age

Pie chart summarizing how many participants of certain age groups were in the TECENTRIQ clinical trial. In total, 127 participants were below 65 years (41%), 126 were between 65 and 75 years old (41%) and 57 participants were 75 and older (18%).

Clinical trial data

Who participated in the trials?

The table below summarizes demographics of patients in the clinical trials.

Table 6. Baseline Demographics of Patients in the Clinical Trial (Safety Population)

  Demographic Parameters  TECENTRIQ (N=310)
n (%)
Sex
   Men241 (78)
   Women69 (22)
Age
   Mean years (SD)65.6 (10.1)
   Median (years)66
   Min, max (years)32,91
Age Group
   < 65="">127 (41)
    65-75 years126 (41)
    ≥75 years57 (18)
Race
   White282 (91)
   Black or African American6 (2)
   Asian7 (2)
  American Indian or Alaska Native1 (<>
  Native Hawaiian or Other Pacific Islander1 (<>
  Other7 (2)
 Unknown6 (2)
Ethnicity
  Hispanic or Latino10 (3)
  Not Hispanic or Latino284 (92)
  Not reported9 (3)
  Unknown7 (2)
Region
   US210 (68)
  Non-US100 (32)

FDA Review

How were the trials designed?

There was one trial that evaluated benefit and side effects of TECENTRIQ. All patients had urothelial cancer that has spread and all received TELECENTRIQ every 3 weeks until either unacceptable side effects or disease progression.

The benefit of TECENTRIQ was evaluated by measuring the percentage of patients who experienced complete or partial shrinkage of their tumors (called objective response rate) and how long the benefit lasts.

How were the trials designed?

The safety and efficacy of TECENTRIQ was evaluated in a single, multicenter, open-label trial that included patients with locally advanced or metastatic urothelial carcinoma.

Patients received an intravenous infusion of TECENTRIQ every 3 weeks until unacceptable toxicity or either radiographic or clinical progression.

Primary efficacy was evaluated confirmed objective response rate (ORR) as assessed by independent review facility using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and duration of response (DoR).

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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