Provectus News
Cutaneous, Locoregional Melanomas Show High, Rapid Responses to Injection With Rose-Bengal Solution
Friday October 3, 2014
An article appearing on FirstWord Pharma reports on data presented at the 2014 European Society for Medical Oncology (ESMO) Congress showing that patients who have all of their cutaneous and subcutaneous melanoma lesions injected with PV-10 experience high, complete treatment responses after only 1 or 2 injections.
A reprint of the article is available at www.pvct.com/news/FirstWordPharma-ESMO-2014-10-02.pdf on the Provectus website.
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Cutaneous, Locoregional Melanomas Show High, Rapid Responses to
Injection With Rose-Bengal Solution
By Walter Alexander
MADRID, Spain -- October 2, 2014 -- Patients who have all of their cutaneous and
subcutaneous melanoma lesions injected with a 10% solution of Rose Bengal (PV-10),
experience high, complete treatment responses after only 1 or 2 injections, according to
researchers at the 2014 European Society for Medical Oncology (ESMO) Congress.
Intralesional injections of PV-10 accumulate rapidly in tumour lysosomes, causing lysosomal
rupture within 30 to 60 minutes and subsequent tumour-cell rupture, noted lead investigator
Sanjiv Agarwala, MD, St. Luke’s University Hospital & Health Network, Bethlehem,
Pennsylvania, speaking here at a poster session on September 28. Research has shown
subsequent tumour-specific T-cell responses to occur within 7 days, he added.
Dr. Agarwala and colleagues previously conducted a phase 2 clinical trial of 80 patients with
cutaneous melanoma refractory to a median of 6 prior interventions. The primary endpoint
was objective response rate (ORR), which was defined as complete plus partial response rate.
Patients in that study received intralesional injections for all of their cutaneous and
subcutaneous melanoma lesions (up to 20) with PV-10 up to 4 times over a 16-week period,
and were followed for 52 weeks. The complete response rate (CRR) among patients with
“bystander lesions” that were left untreated was 23% (confidence interval [CI], 9% to 44%),
and the CRR for the full population of 80 patients was 26%, with an objective response rate
(complete plus partial response rate) of 51% (CI, 40% to 63%).
The current analysis focused on the 28 patients from that previous study in whom all lesions
were injected with PV-10 (the All Lesions Treated group). Dr. Agarwala reported that the CRR
among the 28 patients in the All Lesions Treated group was 50% (CI, 31% to 69%), and the
objective response rate (complete plus partial response) in the group was 71% (CI, 51% to
87%). Patients had a median of 8 study lesions (range, 1 to 22 lesions), with a time to
response of 1.8 months. The partial response rate in the All Lesions Treated group was 21%,
with stable disease at 11%.
In the All Lesions Treated group, 121 complete responses were observed after 1 injection, 84
complete responses after 2 injections, 22 complete responses after 3 injections, and 5
complete responses after 4 injections. |
