Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC - 16/05/15
, Michael R. Migden, MD b, Karl Lewis, MD c, John D. Hainsworth, MD d, James A. Solomon, MD, PhD e, f, g, Simon Yoo, MD h, Sarah T. Arron, MD, PhD i, Philip A. Friedlander, MD, PhD j, k, Ellen Marmur, MD k, Charles M. Rudin, MD, PhD l, Anne Lynn S. Chang, MD m, Luc Dirix, MD, PhD n, Jeannie Hou, MD o, Huibin Yue, PhD o, Axel Hauschild, MD pon behalf of the
ERIVANCE BCC investigators
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.
Le texte complet de cet article est disponible en PDF.Key words : advanced basal cell carcinoma, ERIVANCE BCC study, Hedgehog pathway inhibitor, locally advanced basal cell carcinoma, metastatic basal cell carcinoma, vismodegib
Abbreviations used : AE, BCC, CI, DOR, FDA, IRF, laBCC, mBCC, PFS, TEAE
Plan
| This study was funded by F. Hoffmann-LaRoche and was designed by the investigators and representatives of the sponsor. The sponsor also was responsible for data collection and analysis. Medical writing assistance was provided by Saema Magre, PhD, Tony Serino, PhD, and David Gibson, PhD, CMPP, of ApotheCom (Yardley, PA) and was funded by F. Hoffmann-La Roche. |
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| Dr Sekulic serves as a consultant for F. Hoffman-LaRoche (uncompensated). Dr Migden serves as a consultant for Genentech, Novartis, and Lilly and has received honoraria from Genentech, Novartis, and Lilly. Dr Lewis serves as a consultant for F. Hoffman-LaRoche, has received honoraria from F. Hoffman-LaRoche, and his institution has received grant funding for clinical trials from F. Hoffman-LaRoche. Dr Hainsworth's institution has received grant funding for clinical trials from Genentech. Dr Solomon is a consultant for Genentech, has received honoraria from Genentech, and his institution has received grant funding for clinical trials from Genentech. Dr Yoo is a consultant for Genentech, has received honoraria from Genentech, and his institution has received grant funding for clinical trials from Genentech. Dr Arron serves as a consultant for Genentech, Kythera, Allergan, Anacor, Lilly, and F. Hoffmann-LaRoche, has received salary from Genentech, Kythera, Allergan, Anacor, and Lilly, and has received honoraria from F. Hoffmann-LaRoche. Dr Friedlander serves as a consultant for Genentech and Bristol-Myers, has received honoraria from Genentech and Bristol-Myers Squibb, and his institution has received grant funding from Genentech. Dr Marmur serves as a consultant for Allergan and Dusa Pharmaceuticals. Dr Rudin serves as a consultant for Novartis and Lilly and has received honoraria from Novartis and Lilly. Dr Chang has received grants for clinical trials from F. Hoffmann-La Roche, Novartis, and Lilly. Dr Dirix declared no conflicts of interest. Dr Hou is an employee of Genentech and has received salary, stock options, and stock from Genentech. Dr Yue is an employee of F. Hoffmann-La Roche and has received salary, stock options, and stock from F. Hoffmann-LaRoche. Dr Hauschild serves as a consultant to Amgen, Bristol-Myers Squibb, Celgene, Eisai, GlaxoSmithKline, MedImmune, MelaSciences, Merck Serono, Merck, Novartis, Oncosec, and F. Hoffmann-LaRoche, received honoraria from Amgen, Bristol-Myers Squibb, Celgene, Eisai, GlaxoSmithKline, MedImmune, MelaSciences, Merck Serono, Merck, Novartis, Oncosec, and F. Hoffmann-LaRoche, and grants for clinical trials from Amgen, Bristol-Myers Squibb, Celgene, Eisai, GlaxoSmithKline, MelaSciences, Merck Serono, Merck, Novartis, Oncosec, and F. Hoffmann-LaRoche. |
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| Supplementary data, eTables, and eFigures are available at www.jaad.org. |
Vol 72 - N° 6
P. 1021 - juin 2015 Retour au numéro
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