Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC

Aleksandar D Sekulic, Michael R. Migden, Karl Lewis, John D. Hainsworth, James A. Solomon, Simon Yoo, Sarah T. Arron, Philip A. Friedlander, Ellen Marmur, Charles M. Rudin, Anne Lynn S Chang, Luc Dirix, Jeannie Hou, Huibin Yue, Axel Hauschild

Research output: Contribution to journalArticle

94 Citations (Scopus)

Abstract

Background Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. Objective An efficacy and safety analysis was conducted 12 months after primary analysis. Methods This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. Results After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. Conclusion The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC.

Original languageEnglish (US)
Pages (from-to)1021-1026.e8
JournalJournal of the American Academy of Dermatology
Volume72
Issue number6
DOIs
StatePublished - Jun 1 2015

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HhAntag691
Basal Cell Carcinoma
Safety
Cohort Studies
Outcome Assessment (Health Care)
Radiation

Keywords

  • advanced basal cell carcinoma
  • ERIVANCE BCC study
  • Hedgehog pathway inhibitor
  • locally advanced basal cell carcinoma
  • metastatic basal cell carcinoma
  • vismodegib

ASJC Scopus subject areas

  • Dermatology

Cite this

Pivotal ERIVANCE basal cell carcinoma (BCC) study : 12-month update of efficacy and safety of vismodegib in advanced BCC. / Sekulic, Aleksandar D; Migden, Michael R.; Lewis, Karl; Hainsworth, John D.; Solomon, James A.; Yoo, Simon; Arron, Sarah T.; Friedlander, Philip A.; Marmur, Ellen; Rudin, Charles M.; Chang, Anne Lynn S; Dirix, Luc; Hou, Jeannie; Yue, Huibin; Hauschild, Axel.

In: Journal of the American Academy of Dermatology, Vol. 72, No. 6, 01.06.2015, p. 1021-1026.e8.

Research output: Contribution to journalArticle

Sekulic, AD, Migden, MR, Lewis, K, Hainsworth, JD, Solomon, JA, Yoo, S, Arron, ST, Friedlander, PA, Marmur, E, Rudin, CM, Chang, ALS, Dirix, L, Hou, J, Yue, H & Hauschild, A 2015, 'Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC', Journal of the American Academy of Dermatology, vol. 72, no. 6, pp. 1021-1026.e8. https://doi.org/10.1016/j.jaad.2015.03.021
Sekulic, Aleksandar D ; Migden, Michael R. ; Lewis, Karl ; Hainsworth, John D. ; Solomon, James A. ; Yoo, Simon ; Arron, Sarah T. ; Friedlander, Philip A. ; Marmur, Ellen ; Rudin, Charles M. ; Chang, Anne Lynn S ; Dirix, Luc ; Hou, Jeannie ; Yue, Huibin ; Hauschild, Axel. / Pivotal ERIVANCE basal cell carcinoma (BCC) study : 12-month update of efficacy and safety of vismodegib in advanced BCC. In: Journal of the American Academy of Dermatology. 2015 ; Vol. 72, No. 6. pp. 1021-1026.e8.
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abstract = "Background Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. Objective An efficacy and safety analysis was conducted 12 months after primary analysis. Methods This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. Results After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3{\%} to 33.3{\%} in patients with metastatic disease, and from 42.9{\%} to 47.6{\%} in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. Conclusion The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC.",
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T2 - 12-month update of efficacy and safety of vismodegib in advanced BCC

AU - Sekulic, Aleksandar D

AU - Migden, Michael R.

AU - Lewis, Karl

AU - Hainsworth, John D.

AU - Solomon, James A.

AU - Yoo, Simon

AU - Arron, Sarah T.

AU - Friedlander, Philip A.

AU - Marmur, Ellen

AU - Rudin, Charles M.

AU - Chang, Anne Lynn S

AU - Dirix, Luc

AU - Hou, Jeannie

AU - Yue, Huibin

AU - Hauschild, Axel

PY - 2015/6/1

Y1 - 2015/6/1

N2 - Background Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. Objective An efficacy and safety analysis was conducted 12 months after primary analysis. Methods This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. Results After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. Conclusion The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC.

AB - Background Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. Objective An efficacy and safety analysis was conducted 12 months after primary analysis. Methods This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. Results After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. Conclusion The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC.

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KW - ERIVANCE BCC study

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KW - metastatic basal cell carcinoma

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