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Drug Trials Snapshots: BAVENCIO

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 BAVENCIO Prescribing Information for complete information.

BAVENCIO (avelumab)
buh-VEN-see-oh
EMD Serono, Inc.
Approval date: March 23, 2017


DRUG TRIALS SNAPSHOT SUMMARY:

What is the drug for?

BAVENCIO is used to treat a rare type of skin cancer called Merkel cell carcinoma (MCC) in adults and in pediatric patients 12 years and older. It is used in patients for whom the cancer has spread (metastatic).

BAVENCIO was approved under FDA’s accelerated approval program, which provides earlier patient access to a promising new drug while the company continues to conduct clinical trials to confirm that the drug works well.

How is this drug used?

BAVENCIO is given by a healthcare provider using a needle placed in a vein (known as intravenous infusion) over 60 minutes. BAVENCIO is given every 2 weeks.

What are the benefits of this drug?

Thirty-three percent of 88 patients who were treated with BAVENCIO experienced complete or partial shrinkage of their tumors. The majority of responding patients maintained their response for more than 6 months and nearly half (45 percent) maintained their response for more than 12 months.

More trials are ongoing to confirm the clinical benefit of BAVENCIO.

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

The table below summarizes efficacy results based on overall response rate (ORR) and duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as measured by blinded independent central review.

Table 2. Efficacy Results of Trial 1

Efficacy EndpointsResults
 (N=88)
Overall Response Rate (ORR)
 Overall response rate, (95% CI)
 Complete response (CR) rate, (95% CI)
 Partial response (PR) rate, (95% CI)

33.0% (23.3%, 43.8%)
11.4% (6.6%, 19.9%)
 21.6% (13.5%, 31.7%)
Duration of Response (DOR)
 Range in months
 Patients with DOR ≥ 6 months, n (%)
 Patients with DOR ≥ 12 months, n (%)
N=29
2.8 to 23.3+
25 (86%)
13 (45%)

CI: Confidence interval

BAVENCIO Prescribing Information

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

The trial that looked at the benefit of BAVENCIO was too small to determine if there were any differences in sex, race and age subgroups.

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 of Overall Response Rate (ORR) by sex and age. Racial subgroup differences were not investigated since the majority of patients were white.

Due to the small sample size, these exploratory analyses should be interpreted with caution.

Table 3. Subgroup Analysis of Overall Response Rate (ORR) As Assessed by the Investigator

 ORR
 n (%)
95% CI*
Sex
Men ( N=65)22 (33.8)21.2, 45.1
Women (N=23)7 (30.4)13.2, 52.9
Age Group
<65 years="" (n="">8(36.3)13.9, 54.9
≥65 years (N=66)21 (31.8)20.9, 44.4

*95% Exact Confidence Interval using Clopper-Pearson method

Adapted from Clinical Trial Report

What are the possible side effects?

BAVENCIO can cause the immune system to attack normal organs and tissues which may lead to serious side effects in any part of the body. The most common parts of the body that are affected are the lungs, liver, colon, kidneys, and endocrine glands. BAVENCIO may also cause serious infusion reactions (low blood pressure, difficulty breathing) when it is being given into the vein. All patients should receive medicines before the first four doses of BAVENCIO to help reduce infusion reactions.

Common side effects of BAVENCIO are tiredness, muscle and bone pain, diarrhea, nausea, infusion related reaction, skin rash, decreased appetite, and swelling of the limbs.

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

The tables below summarize adverse reactions and electrolyte abnormalities in the clinical trial.

Table 4. Adverse Reactions in ≥ 10% of Patients with Metastatic MCC Receiving BAVENCIO

Adverse ReactionsBAVENCIO
 (N=88)
All Grades
 %
Grade 3-4
%
General Disorders
Fatiguea502
Infusion‑related reactionb220
Peripheral edemac200
Musculoskeletal and Connective Tissue Disorders
Musculoskeletal paind322
Arthralgia161
Gastrointestinal Disorders
Diarrhea230
Nausea220
Constipation171
Abdominal paine162
Vomiting130
Skin and Subcutaneous Tissue Disorders
Rashf220
Pruritusg100
Metabolism and Nutrition Disorders
Decreased appetite202
Decreased weight150
Respiratory, Thoracic and Mediastinal Disorders
Cough180
Dyspneah110
Nervous System Disorders
Dizziness140
Headache100
Vascular Disorders
Hypertension136

aFatigue is a composite term that includes fatigue and asthenia
bInfusion-related reaction is a composite term that includes drug hypersensitivity, hypersensitivity, chills, pyrexia, back pain, and hypotension
cPeripheral edema is a composite term that includes peripheral edema and peripheral swelling
dMusculoskeletal pain is a composite term that includes back pain, myalgia, neck pain, pain in extremity
eAbdominal pain is a composite term that includes abdominal pain and abdominal pain upper
fRash is a composite term that includes rash maculo-papular, erythema, and dermatitis bullous
gPruritus is a composite term that includes pruritus and pruritus generalized
hDyspnea is a composite term that includes dyspnea and dyspnea exertional

BAVENCIO Prescribing Information

Table 5. Selected Treatment Emergent *Laboratory Abnormalities in Patients Receiving BAVENCIO

Laboratory TestsAny Grade
 (N=88)
 %
Grade 3-4
 (N=88)
%
Chemistry
Increased aspartate aminotransferase (AST)341
Increased alanine aminotransferase (ALT)205
Increased lipase144
Increased amylase81
Increased bilirubin61
Hyperglycemia**-7
Hematology
Anemia359
Lymphopenia4919
Thrombocytopenia271
Neutropenia61

* Treatment emergent consists of new onset of laboratory abnormality or worsening of baseline laboratory abnormality
** Hyperglycemia limited to Grade ≥ 3 events since fasting measurements were not obtained routinely

BAVENCIO Prescribing Information

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

The trial that looked at the side effects of BAVENCIO was too small to determine if there were any differences in sex, race and age subgroups.

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

The table below summarizes adverse events during the clinical trial by sex, and age subgroup. Racial subgroup differences were not investigated since the majority of patients were white.

Due to the small sample size, these exploratory analyses should be interpreted with caution.

Table 6. Subgroup Analysis of Adverse Events by Sex

 Men
N=65
n (%)
Women
N=23
n (%)
Any grade event63 (97)23 (100)
Grade ≥3 event40 (62)14 (63)

Adapted from FDA Clinical review

Table 7. Subgroup Analysis of Adverse Events by Age

 Age < 65="">
N = 22
n (%)
Age ≥65 to <75>
N = 35
n (%)
Age ≥75 Years
N = 31
n (%)
Any grade event22 (100%)35 (100%)29 (94%)
Grade ≥3 event14 (64%)24 (67%)16 (52%)

Adapted from FDA Clinical review

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved BAVENCIO based on evidence from one clinical trial of 88 patients with metastatic MCC and whose tumor was no longer responding to chemotherapy.

The trial was conducted in North America, Western Europe, Australia and Asia.

Figure 1 summarizes how many men and women were enrolled 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 BAVENCIO . In total, 65 men (74%) and  23 women (26%) participated in the clinical trial.

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 patients by race in BAVENCIO clinical trial. In total, 81 Whites (92%), 3 Asians (3%), and 4 Other (5%), participated in the clinical trial.

Clinical trial data

Table 1. Baseline Demographics by Race

RaceNumber of PatientsPercentage
White8192
Asian33
Not collected at the site33
Unknown11

Clinical trial data

Figure 3 summarizes how many patients of certain age 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, 22 patients  were younger than 65 years (25%), and 66 patients were  65 years and older (75 %).

Clinical trial data

Who participated in the trials?

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

Table 8. Baseline Demographics of Patients in the Clinical Trial

Demographic ParametersBAVENCIO
N=88
n (%)
Sex
Men65(74)
Women23(26)
Age
Median (Range)73 (33, 88)
Age Group
<65>22(25)
≥65 years66(75)
Race
White81 (92)
Asian3 (3)
Not collected at the site3 (3)
Unknown1 (1)
Region
North America51 (58)
Western Europe29 (33)
Australia5 (6)
Asia3 (3)

FDA review

How were the trials designed?

The benefit and side effects of BAVENCIO were evaluated in one clinical trial of patients with metastatic MCC. All patients received BAVENCIO once every two weeks until either the tumors grew or the patients developed an unacceptable side effect.

The benefit of BAVENCIO was evaluated by measuring how many patients had tumor shrinkage (response) and by how long that response lasted.

How were the trials designed?

There was one single-arm, open-label, multicenter clinical trial that enrolled patients with histologically confirmed metastatic MCC whose disease had progressed (grown larger) on or after chemotherapy administered for metastatic MCC. Patients received BAVENCIO 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

The efficacy outcome measures were confirmed overall response rate (ORR) and duration of response, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as measured by blinded independent central review and duration of response.

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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