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ERIVANCE Phase II pivotal trial design
ERIVANCE results
STEVIE post-approval study
ERIVANCE long-term results

ERIVANCE Phase II Pivotal Trial Design

ERIVANCE: The pivotal trial that demonstrated clinically meaningful benefit in advanced BCC

Study design: ERIVANCE was a Phase II, international, single-arm, 2-cohort, open-label trial5,6

Conducted in 104 patients with either metastatic BCC (n=33) or locally advanced BCC (n=71).

Of the 104 patients enrolled, 96 patients were evaluable for objective response rate (ORR).

Erivedge pivotal trial design details, including dosing and treatment timeline

  • Patients were seen at baseline and every 4 weeks for safety monitoring

  • Patients were seen at baseline and every 8 weeks for response assessment

Primary efficacy outcome measures5

ORR as assessed by independent review. See assessment criteria below for locally advanced BCC and metastatic BCC cohorts.

Baseline characteristics of evaluable patients5,6

Demographic and baseline characteristics

21% of patients had a preexisting diagnosis of Gorlin syndrome and met the inclusion criteria for advanced BCC.

Age

Locally advanced BCC (n=63)

Metastatic BCC (n=33)

All evaluable patients (N=96) 

Median

62 years

62 years

62 years

(Range)

(21-101)

(38-92)

(21-101)

Gender

      

Female

44%

27%

39%

Male

56%

73%

61%

Race

% White

100%

100%

100%

Prior cancer treatment

      

Any therapy

94%

97%

  

Surgery

89%

97%

  

Radiotherapy

27%

58%

  

Systemic therapy

11% (systemics/topicals)

30% (systemics)

  

ERIVANCE Results

ERIVANCE: The pivotal trial that demonstrated clinically meaningful benefit in advanced BCC

Assessment of objective response in locally advanced BCC5,6

A composite endpoint was used to assess response.

Objective response required the absence of disease progression and ≥1 of the following:

Erivedge reduced disease burden visibly and histologically5,6

Primary endpoint: Locally advanced BCC ORR by independent review

Primary endpoint efficacy results from the Erivedge clinical trials

Patients received at least 1 dose of Erivedge with independent pathologist-confirmed diagnosis of BCC. Locally advanced BCC patients were considered responders if they did not experience progression and had ≥30% reduction in lesion size (sum of the longest diameter) from baseline in target lesions by radiography or in externally visible dimensions of target lesions (scar tissue was measured); or had complete resolution of ulceration in all target lesions. Complete response was objective response with no residual BCC on sampling biopsy. Partial response was objective response with presence of residual BCC on sampling biopsy. 

CI=confidence interval; ORR=objective response rate.

  • Scar tissue was measured as part of the lesion when assessing response, as specified in the study protocol
  • Independent review of response included measurement of externally assessable tumor (including scar) and assessment for ulceration in photographs, radiographic assessment of target lesions (if appropriate), and tumor biopsy
  • Median duration of response was 7.6 months (range, 1.0 to 12.9 months; 95% CI, 5.7–9.7)
    • 13 of 27 responding patients were no longer considered responders due to an event (disease progression or death)1

Assessment of objective response in metastatic BCC5,6

Response is confirmed if present on 2 consecutive radiographic scans ≥4 weeks apart

Lungs with tumors representing a partial response in tumor size reduction

Partial response: ≥30% size reduction

Lungs with no tumors representing a complete response in tumor size reduction

Complete response: Complete disappearance of all target lesions

Erivedge reduced disease burden radiographically5,6

Erivedge was the first FDA-approved therapy for metastatic BCC2

Primary endpoint: Metastatic BCC ORR by independent review
Metastatic basal cell carcinoma efficacy results from the Erivedge clinical trials

Patients received at least 1 dose of Erivedge with independent pathologist-confirmed diagnosis of BCC. In the metastatic BCC cohort, response was assessed according to RECIST version 1.0. Complete response was disappearance of all target and non-target lesions. Partial response was ≥30% decrease in SLD of target lesions from baseline.

CI=confidence interval; ORR=objective response rate; RECIST=Response Evaluation Criteria in Solid Tumors; SLD=sum of the longest diameter.

  • Median duration of response was 7.6 months (range, 2.1 to 11.1 months; 95% CI, 5.6–not estimable)
    • 3 of 10 responding patients were no longer considered responders due to an event (disease progression or death)1

Most common adverse reactions (incidence ≥10%) associated with Erivedge: Pooled analysis of 4 studies1,5,17

 

All advanced BCC patients (N=138)

Adverse reactions occurring in ≥10% of advanced BCC patients 

Grade 1 (%) (Mild)

Grade 2 (%) (Moderate)

Grade 3 (%) (Severe)

Grade 4 (%) (Disabling or life-threatening)

All grades (%) 

Muscle spasms

51.4%

16.7%

3.6%

-

72%

Alopecia

49.3%

14.5%

N/A

N/A

64%

Change in taste (dysgeusia)

34.1%

21.0%

N/A

N/A

55%

Weight loss

25.4%

12.3%

7%

N/A

45%

Fatigue

27.5%

6.5%

5%

0.7%

40%

Nausea

23.9%

5.8%

0.7%

-

30%

Diarrhea

21.7%

6.5%

0.7%

-

29%

Decreased appetite 

15.2%

8.0%

2.2%

-

25%

Constipations

17.4%

3.6%

-

-

21%

Arthralgias

11.6%

3.6%

0.7%

-

16%

Vomiting

10.9%

2.9%

-

-

14%

Loss of taste (ageusia)

8.0%

2.9%

N/A

N/A

11%

Adverse reactions reported using Medical Dictionary for Regulatory Activities preferred terms and graded using National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 for assessment of toxicity.
N/A=not applicable, this grade does not exist for this adverse reaction.

  • Amenorrhea can occur in females of reproductive potential. Reversibility of amenorrhea is unknown. In clinical trials, 30% of 10 pre-menopausal women developed amenorrhea while receiving Erivedge
  • Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia (4%), azotemia (2%), and hypokalemia (1%)
  • Additionally, in a post-approval clinical trial conducted in 1232 patients with locally advanced or metastatic BCC treated with Erivedge, a subset of 29 patients had baseline values for blood creatine phosphokinase (CPK) reported. Within the subset of patients, 38% had a shift from baseline, including Grade 3 (3%) increased CPK. Grade 3 or 4 increased CPK occurred in 2.4% of the 453 patients across the entire study population with any CPK measurement
  • Twenty-nine patients (28%) experienced adverse reactions that led to treatment interruption

STEVIE (post-approval study)

Clinical trial information for STEVIE1,26,28,30*

Overview

Single-arm, international, open-label, post-approval study to fulfill a European post-marketing commitment

Primary objective

Safety

Safety-evaluable patients (n)

1215† (laBCC: n=1119; mBCC: n=96)

Median age (range)

72 years (18-101)

% White

72.4

% Male

57.1

Treatment

Oral Erivedge 150 mg daily until disease progression, intolerable toxicity, or withdrawal from study

Median duration of treatment

8.6 months

Treatment interruptions
  • Up to 8-week treatment interruptions for intolerable adverse reactions potentially related to Erivedge or inability to swallow capsules
  • 487 patients (40.1%) experienced adverse reactions leading to treatment interruption

Study limitations

Absence of a control arm and lack of independent central review

Exploratory endpoint: time to resolution after treatment discontinuation

466 patients from STEVIE were analyzed for the time to resolution after treatment discontinuation for each of the adverse reactions. This was the population still experiencing adverse reactions at the time of discontinuation and who completed the 12-month follow-up visit. Median follow-up after treatment discontinuation of 12.1 months (range, 10.0 to 17.6 months).1

Limitations: Because clinical trials are conducted under widely varying conditions, time to onset and resolution of adverse reactions observed in the clinical trials of a drug cannot be directly compared to those observed in other clinical trials of that drug and may not reflect actual clinical practice. This endpoint is exploratory and no formal inferences can be drawn.

Exploratory endpoint: treatment interruptions

Limitations: Because clinical trials are conducted under widely varying conditions, duration of treatment, number of treatment interruptions, and duration of treatment interruption observed in the clinical trial of a drug may not reflect actual clinical practice. This endpoint is exploratory and post-hoc, and no formal inferences can be drawn. Treatment interruption data are not exclusively a result of adverse reactions. The patients captured do not include the total population who took treatment interruptions due to incomplete dosing information for some patients.

*From final data cut June 14, 2017.26
†Patients who received at least 1 dose of Erivedge.

ERIVANCE Long-term Results23

Introduction to the ERIVANCE data

Erivedge capsule was approved based on the pivotal ERIVANCE trial—a Phase II, single-arm, 2-cohort, multicenter study that demonstrated clinically meaningful benefit in advanced basal cell carcinoma (BCC). The study conducted an initial primary analysis by independent review at 9 months minimum follow-up and a final, long-term analysis at 39 months minimum follow-up as assessed by investigator.

Safety data

All treated patients were considered evaluable for safety. Safety analyses included frequency and severity of treatment-emergent adverse events (TEAEs), adverse events leading to treatment interruption or discontinuation, serious adverse events, and death. The incidence of these adverse events generally increased with longer durations of exposure to Erivedge.

Most-common TEAEs according to duration of exposure to Erivedge

TEAE occurring in >20%

of patients, n (%)*

Exposure <12 months (n=48)

Exposure ≥12 months (n=56)
 

Any Grade

Grade 3†

Any Grade

Grade 3†

Any AE

48 (100.0)

27 (56.3)

56 (100.0)

31 (55.4)

Muscle spasms

25 (52.1)

2 (4.2)

49 (87.5)

4 (7.1)

Alopecia

24 (50.0)

N/A

45 (80.4)

N/A

Dysgeusia

20 (41.7)

N/A

38 (67.9)

N/A

Weight decreased

18 (37.5)

0

36 (64.3)

9 (16.1)

Fatigue

17 (35.4)

4 (8.3)

28 (50.0)

1 (1.8)

Nausea

11 (22.9)

0

23 (41.1)

0

Decreased appetite

15 (31.3)

2 (4.2)

14 (25.0)

1 (1.8)

Diarrhea

10 (20.8)

0

18 (32.1)

3 (5.4)

Constipation

10 (20.8)

0

10 (17.9)

0

Cough

8 (16.7)

0

12 (21.4)

0

Arthralgia

5 (10.4)

0

12 (21.4)

1 (1.8)

*Medical Dictionary for Regulatory Activities–preferred term.
†NCI CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.

AE=adverse event; NA=not applicable.

Efficacy data: objective response rate (ORR) and duration of response (DOR)

Primary analysis: 9 months minimum follow-up*

The study conducted an initial primary analysis by independent review at 9 month’s minimum follow-up and a final, long-term analysis by investigator at 39 month’s minimum follow-up. The primary endpoint was ORR as assessed by independent review. Select secondary endpoints included investigator-assessed ORR, as well as independent review and investigator-assessed DOR and safety.6 Of the 104 patients enrolled, 96 were evaluable for ORR.5

Limitations: absence of a control arm6

 

Independent review5†

Investigator assessment‡

secondary endpoint
 

Locally advanced BCC (n=63)

Metastatic BCC (n=33)

Locally advanced BCC (n=63)

Metastatic BCC (n=33)
ORR 42.9%† (n=27)
primary endpoint		 30.3%† (n=10)
primary endpoint		 60.3% (n=38) 45.5% (n=15)

(95% CI)

(30.5-56.0)

(15.6-48.2)

(47.2-71.7)

(28.1-62.2)

Complete response

20.6% (n=13)

0% (n=0)

31.7% (n=20)

0% (n=0)

Partial response 

22.2% (n=14)

30.3% (n=10)

28.6% (n=18)

45.5% (n=15)

Median DOR (months)

7.6

7.6

7.6

12.9

(95% CI)

(5.7-9.7)

(5.6-NE)

(7.4-NE)

(5.6-12.9)

*The median duration of treatment was 10.2 months (range, 0.7 to 18.7 months).5

†Patients received at least 1 dose of Erivedge with independent pathologist-confirmed diagnosis of BCC. Locally advanced BCC patients were considered responders if they did not experience progression and had 30% reduction in lesion size (sum of the longest diameter) from baseline in target lesions by radiography or in externally visible dimensions of target lesions (scar tissue was measured); or had complete resolution of ulceration in all target lesions. Complete response was objective response with no residual BCC on sampling biopsy. Partial response was objective response with presence of residual BCC on sampling biopsy. In the metastatic BCC cohort, response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response was disappearance of all target and non-target lesions. Partial response was 30% decrease in SLD of target lesions from baseline. The primary endpoint was the independently assessed objective response rate.5

‡Concordance between IRF and INV assessment of ORR was 79% for mBCC and 60% for laBCC due to investigator's assessing a response and IRF not assessing a response.

INV=investigator; IRF=independent review facility; NE=not estimable.

Final analysis (secondary endpoint): 39 month’s minimum follow-up§

Investigator-assessed ORR and DOR. For the final follow-up at 39 months, all assessments were secondary endpoints as assessed by investigators. 69 patients remained in the survival follow-up (96 patients had discontinued treatment).‖

Limitations: absence of a control arm and lack of independent assessment5

 

Investigator assessment

Locally advanced BCC (n=63)

Metastatic BCC (n=33)

ORR

60.3% (n=38)

48.5% (n=16)

(95% CI)

(47.2-71.7)

(30.8-66.2)

Complete response 

31.7% (n=20)

0% (n=0)

Partial response 

28.6% (n=18)

48.5% (n=16)

Median DOR (months)

26.2

14.8

(95% CI)

(9.0-37.6)

(5.6-17.0)

§Overall, median duration of treatment on Erivedge was 12.9 months.
‖Primary reasons for discontinuation: disease progression (27.9%), patient decision (26%), adverse reactions (21.2%), and other reasons (17.5%).

Because different standards are used for independent review and investigator assessment, no formal treatment comparisons can be made.

NEXT: Help patients manage side effects

Side Effects & Tips

Read about possible side effects of Erivedge and get ideas on how to manage them.

Read side effects

Indication and Important Safety Information

Indication

Erivedge is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation.

Important Safety Information

BOXED WARNING: EMBRYO-FETAL TOXICITY

  • Erivedge can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Erivedge is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations
  • Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating Erivedge. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after Erivedge
  • Advise males of the potential risk of Erivedge exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential
Warnings and Precautions
 
Embryo-Fetal Toxicity
  • Females of Reproductive Potential: Use contraception during therapy with Erivedge and for 24 months after the final dose
  • Males: Use condoms, even after a vasectomy, to avoid potential drug exposure in pregnant partners and female partners of reproductive potential during and for 3 months after the final dose of Erivedge. Do not donate semen during and for 3 months after the final dose of Erivedge
  • Blood Donation: Advise patients not to donate blood or blood products while receiving Erivedge and for 24 months after the final dose of Erivedge
  • Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy. Report pregnancies to Genentech at (888) 835-2555
Severe Cutaneous Adverse Reactions
  • Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with Erivedge. Permanently discontinue Erivedge in patients with these reactions
Musculoskeletal Adverse Reactions
  • Musculoskeletal adverse reactions, which may be accompanied by serum creatine phosphokinase (CPK) elevations, have occurred with Erivedge and other drugs which inhibit the hedgehog (Hh) pathway. In the pooled safety population in clinical trials of Erivedge, musculoskeletal and connective tissue adverse reactions occurred in 78% of patients treated, with 7% (9/138) reported as Grade 3. The most frequent manifestations of musculoskeletal and connective tissue adverse reactions (all grades) reported were muscle spasms (72%) and arthralgias (16%). In a post-approval clinical trial of 1232 patients, Grade 3 or 4 elevations in serum CPK laboratory values occurred in 2.4% of the 453 patients who had any CPK measurement
  • Obtain baseline serum creatine phosphokinase (CPK) and creatinine levels and as clinically indicated (e.g., if muscle symptoms are reported). Depending on the severity of symptoms, temporary dose interruption or discontinuation may be required for musculoskeletal adverse reactions or serum CPK elevation
Premature Fusion of the Epiphyses
  • Premature fusion of the epiphyses has been reported in pediatric patients exposed to Erivedge. In some cases, fusion progressed after drug discontinuation. Erivedge is not indicated for pediatric patients

Adverse Reactions

  • The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia
  • Amenorrhea can occur in females of reproductive potential. Reversibility of amenorrhea is unknown. In clinical trials, 30% of 10 pre-menopausal women developed amenorrhea while receiving Erivedge
  • Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia (4%), azotemia (2%), and hypokalemia (1%)
  • Additionally, in a post-approval clinical trial conducted in 1232 patients with locally advanced or metastatic BCC treated with Erivedge, a subset of 29 patients had baseline values for blood creatine phosphokinase (CPK) reported. Within the subset of patients, 38% had a shift from baseline, including Grade 3 (3%) increased CPK. Grade 3 or 4 increased CPK occurred in 2.4% of the 453 patients across the entire study population with any CPK measurement
  • Adverse reactions identified during post-approval use: drug-induced liver injury, Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms

Use in Specific Populations

Lactation

  • No data are available regarding the presence of vismodegib in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Advise women that breastfeeding is not recommended during therapy with Erivedge and for 24 months after the final dose

 

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see full Prescribing Information, including the BOXED WARNING, for a complete discussion of the risks associated with Erivedge.

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