Aleksandar Sekulic1, Michael R Migden2, Karl Lewis3, John D Hainsworth4, James A Solomon5, Simon Yoo6, Sarah T Arron7, Philip A Friedlander8, Ellen Marmur9, Charles M Rudin10, Anne Lynn S Chang11, Luc Dirix12, Jeannie Hou13, Huibin Yue13, Axel Hauschild14. 1. Mayo Clinic, Scottsdale, Arizona. Electronic address: sekulic.aleksandar@mayo.edu. 2. University of Texas MD Anderson Cancer Center, Houston, Texas. 3. University of Colorado Cancer Center, Denver, Colorado. 4. Sarah Cannon Research Institute, Nashville, Tennessee. 5. Ameriderm Research, Ormond Beach, Florida; University of Central Florida, Orlando, Florida; University of Illinois, Urbana, Illinois. 6. Northwestern University, Evanston, Illinois. 7. University of California, San Francisco, San Francisco, California. 8. Dana-Farber Cancer Institute, Boston, Massachusetts; Mount Sinai Medical Center, New York, New York. 9. Mount Sinai Medical Center, New York, New York. 10. Johns Hopkins University, Baltimore, Maryland. 11. Stanford University School of Medicine, Palo Alto, California. 12. Sint-Augustinus Hospital, Antwerp, Belgium. 13. Genentech Inc, South San Francisco, California. 14. Universitätsklinikum Schleswig-Holstein, Kiel, Germany.
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.
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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Authors: Andrzej T Slominski; Anna A Brożyna; Michal A Zmijewski; Zorica Janjetovic; Tae-Kang Kim; Radomir M Slominski; Robert C Tuckey; Rebecca S Mason; Anton M Jetten; Purushotham Guroji; Jörg Reichrath; Craig Elmets; Mohammad Athar Journal: Adv Exp Med Biol Date: 2020 Impact factor: 2.622