Efficacy of intralesional Rose Bengal in patients receiving injection of all existing melanoma in phase II study PV-10-MM-02.

Melanoma/Skin Cancers
Session Type and Session Title: 
Poster Highlights Session, Melanoma/Skin Cancers
Abstract Number: 
J Clin Oncol 32:5s, 2014 (suppl; abstr 9027)
Sanjiv S. Agarwala, John F Thompson, B Mark Smithers, Merrick I. Ross, Charles Raben Scoggins, Brendon J Coventry, Susan J Neuhaus, David R. Minor, Jamie M Singer, Eric Andrew Wachter; St. Luke's Hospital and Health Network, Easton, PA; Melanoma Institute Australia, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia; Princess Alexandra Hospital, Brisbane, Australia; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Louisville, Louisville, KY; Royal Adelaide Hospital, Adelaide, Australia; University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia; California Pacific Medical Center Research Institute, San Francisco, CA; Provectus Biopharmaceuticals, Inc., Knoxville, TN

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Abstract Disclosures


Background: The safety and efficacy of intralesional (IL) treatment of refractory cutaneous melanoma with rose bengal disodium (PV-10) was evaluated in an 80 patient international, multicenter, single arm phase II trial (NCT00521053). Overall, PV-10 was well tolerated and 41 of 80 ITT patients (pts) met the primary endpoint of objective response (CR+PR) in their injected target lesions (51% ORR CI 40-63%, 26% CR). Methods: Refractory pts (median of 6 previous interventions, 6.3 cm median sum lesion diameter in biopsy confirmed melanoma) received PV-10 into up to 20 cutaneous and subcutaneous lesions up to 4 times over a 16-week period and were followed for 52 weeks. Best overall response rate (BORR) was assessed by RECIST in up to 10 injected target lesions. Secondary endpoints included assessment of duration of response, BORR of untreated bystander lesions, overall survival and adverse events.Confidence intervals for response rates were based on the exact cumulative probabilities of the binomial distribution (95% confidence intervals). Results: In the subgroup of 28 pts who received PV-10 into all existing melanoma lesions (i.e., no uninjected lesions), ORR by-patient was 71% (CI 51-87%) with 50% CR (CI 31-69%). In these pts with all disease injected plus 26 pts with uninjected disease limited to bystanders (i.e. 54 pts with all disease monitored), CR was achieved in 232 of the 363 injected lesions (64% CR): 121 lesions required a single injection for CR, 84 required 2 injections, 22 required 3 injections and 5 required 4 injections. Additionally, 10 of 28 uninjected bystander lesions achieved CR. Conclusions: Recurrent locoregional melanoma can be a source of persistent morbidity, including disfigurement frequently accompanied with pain, ulceration, bleeding and infection. The high rate of symptom control in refractory patients, manifest in CR of injected lesions after minimal intervention, is the basis for a breakthrough therapy application based on the 28 patient “all treated” subgroup. Although the primary ablative effect is responsible for CR in injected tumors, durability of response and bystander response implicate an immunologic mechanism of action secondary to ablation. Clinical trial information: NCT00521053.