Results of a Phase 2 Multicenter Study to Evaluate the Efficacy of VP-315, an Investigational Therapy for Basal Cell Carcinoma

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Jonathan Kantor MD
Neal Bhatia MD
Lawrence Green MD
Jonathan Weiss MD
Kenneth Y. Tsai, MD, PhD
Cynthia Willson RN, BSN
Susan Cutler DMD
Jayson Rieger PhD, MBA
David K. Glover ME, PhD
Pamela Rumney RN, CCRC
Thomas F. Haws
Gary Goldenberg MD

Keywords

Basal Cell Carcinoma, Immunotherapy

Abstract

Introduction: VP-315 is an intratumorally injected, chemotherapeutic oncolytic peptide in development as a non-surgical immunotherapeutic agent to be utilized as first line therapy in a primary or neoadjuvant setting for patients with basal cell carcinoma (BCC).


Objective: In Part 2 of this study, the secondary objective was to evaluate the effect of various dosing regimens on the antitumor efficacy of VP-315 in a larger population of adult subjects with biopsy proven BCC.


Methods: Eighty-two (82) subjects with up to 2 target BCC tumors (total 91 tumors) were treated intratumorally with VP-315 for up to 2 weeks. Cohort 3 was not enrolled based on results from Cohorts 1-2. Each 7-day treatment week was comprised of 2 or 3 consecutive treatment days followed by a no-treatment period of at least 4 days. Dosing scheme:


Cohort 1: (n=6) Tumor injected 3 days consecutively (3X/week 4 mg loading dose Day 1 followed by 8 mg dose).


Cohort 2: (n=3) Tumor injected 3 days consecutively (3X/week 8 mg dose).


Cohort 4: (n=36) Each tumor was injected 2 days consecutively (2X/week 8 mg split dose*).


Cohort 5: (n=37) Each tumor was injected 3 days consecutively (3X/week 8 mg split dose*).


* Dose split into 2 injections, 30% injected initially; 70% injected 15-30 minutes later. 


Efficacy endpoints included histological clearance of target tumor(s) and estimate of remaining tumor volume (tumor size reduction) at excision (Week 12-13).


Results: Eighty-two (82) subjects (n=92 lesions) completed treatment for BCC with VP-315 in Part 2.  Approximately 51% of tumors achieved complete histologic clearance. All tumors treated had a reduction in tumor size. Overall tumor size reduction was 86%. Tumor size reduction in subjects who still had any residual tumor was 71%.


Conclusion: Complete histological clearance in a majority of VP-315 treated tumors could eliminate the need for surgical intervention in those patients in clinical practice.  In subjects with residual tumor burden, the substantial reduction in tumor size after VP-315 treatment would markedly reduce the surgical incision area and the amount of potential post-surgical scarring. Based on the favorable results, further research using VP-315 as a potential non-surgical immunotherapy for BCC as a first line therapy in a primary or neoadjuvant setting is warranted.

References

1. Sveinbjørnsson B, et al. Future Med Chem. 2017;9(12):1339-44.

2. Eike LM, et al. Oncotarget. 2015;6(33):34910-23.

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