Expanded access study of patients with advanced basal cell carcinoma treated with the Hedgehog pathway inhibitor, vismodegib Anne Lynn S. Chang, MD,

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Expanded access study of patients with advanced basal cell carcinoma treated with the Hedgehog pathway inhibitor, vismodegib Anne Lynn S. Chang, MD, James A. Solomon, MD, PhD, John D. Hainsworth, MD, Leonard Goldberg, MD, Edward McKenna, PharmD, BCOP, Bann-mo Day, PhD, Diana M. Chen, MD, Glen J. Weiss, MD Journal of the American Academy of Dermatology Volume 70, Issue 1, Pages 60-69 (January 2014) DOI: 10.1016/j.jaad.2013.09.012 Copyright © 2013 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 CONSORT schematic on patient enrollment. Percentages were based on patients enrolled (n = 120). *One patient was inadvertently assigned a new patient identification number after rejoining the study, 5 months after being lost to follow-up. All results for this patient were presented under the original patient identification number. †One patient was not included in the safety-evaluable population because the patient started the first cycle of treatment and then was lost to follow-up. As the drug bottle or drug diary was not returned to the site, it could not be confirmed how many (if any) doses had been taken. ‡Patients could be counted in more than 1 of the efficacy-nonevaluable reasons. §Defined as enrolled patients who had received at least 1 dose of vismodegib. ¶Defined as patients who had received at least 1 dose of vismodegib, had measurable disease at baseline, and had at least 1 follow-up tumor assessment or died within 30 days from the last dose of study drug. laBCC, Locally advanced BCC; mBCC, metastatic BCC. Journal of the American Academy of Dermatology 2014 70, 60-69DOI: (10.1016/j.jaad.2013.09.012) Copyright © 2013 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Cumulative occurrence of adverse events (AEs) by cycle. AEs with earlier onset included muscle spasm and dysgeusia. AEs with later onset included alopecia and weight loss. Journal of the American Academy of Dermatology 2014 70, 60-69DOI: (10.1016/j.jaad.2013.09.012) Copyright © 2013 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 Maximum postbaseline percentage decrease in the sum of the longest diameters (SLD) of measurable lesions in patients. Data for patients with locally advanced (A) and metastatic (B) basal cell carcinoma. Each column represents an individual patient. Journal of the American Academy of Dermatology 2014 70, 60-69DOI: (10.1016/j.jaad.2013.09.012) Copyright © 2013 American Academy of Dermatology, Inc. Terms and Conditions

Fig 4 Case studies of patients with advanced basal cell carcinoma (BCC). A, Retreatment with vismodegib demonstrating a mixed response, with left preauricular showing stable disease followed by progressive disease even though a separate scalp lesion showed complete response. B, A patient with basal cell nevus syndrome and periocular locally advanced BCCs in the right medial canthus and left lateral canthus with durable complete response after study end, as followed up in dermatology clinic 20 months after vismodegib initiation. All photographs are presented in this article with the consent of the patients obtained by the authors. Journal of the American Academy of Dermatology 2014 70, 60-69DOI: (10.1016/j.jaad.2013.09.012) Copyright © 2013 American Academy of Dermatology, Inc. Terms and Conditions