September 17, 2014

#ESMO14: Subgroup efficacy in patients receiving intralesional rose bengal to all existing melanoma in phase II study PV-10-MM-02

The abstract of Provectus and its principal investigators from the company's metastatic melanoma Phase 2 trial was posted today on the 2014 European Society for Medical Oncology's conference website. The ESMO 2014 conference runs from September 26th to 30th in Madrid, Spain, and Provectus' poster is slated for the 28th. The poster is an extension of/related to the company's 2014 American Society of Clinical Oncology annual meeting poster Efficacy of intralesional rose bengal in patients receiving injection in all existing melanoma in phase II study PV-10-MM-02, where the sub-group of "All Melanoma Followed" (n=54 [out of 80]) was highlighted, together with the "Bystanders Treated" (n=26) and "All Lesions Treated" (n=28) sub-sub-groups. Both posters ultimately derive, in my view, from Provectus' 2013 European Cancer Congress poster Locoregional Disease Control in Metastatic Melanoma: Exploratory Analyses From Phase 2 Testing of Intralesional Rose Bengal.

The ESMO 2014's abstract's conclusion reads:
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, was the basis for a breakthrough therapy designation application to the US FDA based on the 28 patient “all treated” subgroup, and implications of the Agency’s ruling on this application will be presented. 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. {Underlined emphasis is mine}
More information may or will of course be forthcoming on the conference poster, such as:
  • Potentially, further details on the upcoming pivotal Phase 3 trial for unresectable locally advanced cutaneous melanoma,
  • Curiously, the implications of the FDA ruling on Provectus' breakthrough therapy application, and
  • Specifically, more data on the All Disease Treated sub-sub-group, such as durability of response.

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