Rose Bengal (PV-10) at Melanoma Centers Meeting 2010


Dr. Sanjiv Agarwala presented an update on Phase II trial of PV-10 oncolytic  injections (Provectus/Rose Bengal). Not really any new data presented but updates of new protocol plans discussed.

Response rates: 24% CR / 25% PR in target lesions. Local disease control rate over 70%.

What is bystander effect? This means that distant, non-injected site(s) of disease respond when local disease injected. I believe this will be crucial to approval, because it will result in systemic benefit from local injections. Prelim data shows this correlates with responding injected lesions (which makes sense). The exact percentage of bystander effect appears to correlate somewhat also with location of distant disease and also stage of disease, although there have been shrinkage of distant visceral (lung) lesions.

Prelim survival data: Stage III mean PFS about 8 months.

Currently: Phase 2 expanded access trials in melanoma and other skin cancers. Phase 2B trial planned to look at immunologic mechanism of bystander effect, at Moffitt Cancer Center. Not yet started.

Phase 3 RCT design not yet completed, still being finalized and in conversations with FDA, to be done under SPA. Still not clear what control arm will be.

In conclusion, Rose Bengal remains a drug in development that has shown significant locoregional effect and potentially systemic (bystander) effects also. Approval will not take place without a Phase III trial, which has not yet been initiated. From a timeline perspective, advancing this drug through the approval process will depend upon the outcome variables demanded by the FDA, which remain (apparently) still in development/negotiation.

Eric D. Whitman, MD

Senior Editor

TheMelanomaCenter.com

 


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