On December 1, 2022 Provectus (OTCQB: PVCT) reported that new data from the Company’s ongoing, multi-cohort, Phase 1b/2 study of the combination of small molecule cancer immunotherapy PV-10, an intratumoral formulation of Provectus’ rose bengal sodium (RBS) active pharmaceutical ingredient, and anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of immune checkpoint blockade (CB)-naïve Stage III cutaneous melanoma (NCT01223415) are being presented at Melanoma Bridge 2022 in Naples, Italy and online from December 1-3, 2022.

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Entitled "Response for combination of PV-10 autolytic immunotherapy and immune checkpoint blockade in stage III cutaneous melanoma," the video oral communication and poster presentation are available by clicking on the Company website links below:

The video communication narrated by Chief Technology Officer Eric Wachter, PhD, and
The conference poster.
Key Highlights of the Melanoma Bridge 2022 Presentation:

Efficacy (6 patients; investigator-assessed RECIST v1.1)
50% complete response (CR) (3/6) and 83% overall response rate (ORR) (5/6)
Rapid CRs – 2 within 15 weeks and 1 within 27 weeks
Durability

Median progression-free survival (PFS) not reached during 2-year treatment interval; 83% PFS rate
All CRs ongoing after 18 to 36 months of study follow-up
Survival

Median overall survival (OS) not reached
100% OS rate for CRs; ongoing after 18 to 36 months of study follow-up
Safety

Consistent with established patterns of PV-10 and Keytruda single-agent use
Consistent with prior PV-10 and Keytruda combination therapy cohorts of CB-naïve and CB-refractory advanced melanoma patients1,2
Mechanism of immune action

Precise, increased, PV-10-induced T-cell activity preceded CR
Similar immune upregulation observed in (a) monotherapy PV-10 treatment of Stage III melanoma patients3 and (b) PV-10 and Keytruda combination treatment of CB-refractory advanced melanoma patients2
Dominic Rodrigues, Vice Chair of Provectus’ Board of Directors said, "These data demonstrate the potential for rapid, durable, complete response in Stage III melanoma patients by combining individually active anticancer agents PV-10 and checkpoint blockade. Intratumoral PV-10 treatment and as-needed retreatment of baseline and any new melanoma lesions use checkpoint blockade to boost the precise, tumor-specific, systemic adaptive immune response generated from the response of PV-10-injected lesions to drive robust patient outcomes."

Planned Combination PV-10 and CB Treatment of 1st-Line Stage III Melanoma

Successfully combining PV-10 and CB in Stage III melanoma patients (50% CR and 83% ORR) is predicated on achieving rapid response of PV-10-injected lesions that may lead to rapid, durable CR of patients and ultimately to improved PFS and OS:

Single-agent PV-10 achieved 56% CR (and 63% ORR) of injected lesions in Stage III patients4, but only 23% CR (and 54% ORR) of non-injected lesions, and a median PFS of 8.9 to 9.8 months 5,
Single-agent CB may exhibit a similar response rate in Stage III (M0) patients (27% CR and 54% ORR) to PV-10’s response rate in non-injected lesions, with a median PFS of 11.7 months 6, and
The combination of PV-10 and CB in CB-naïve Stage IV patients has shown the potential for significant combinational interaction and durability, while also presenting a non-overlapping safety profile1,7.
Mr. Rodrigues added, "To prove the synergistic clinical benefit of combining PV-10 and checkpoint blockade for the first-line treatment of Stage III melanoma, we plan to initiate a Phase 2/3 randomized control trial of PV-10 and standard of care checkpoint blockade versus standard of care checkpoint blockade in 2023. This trial is essentially a head-to-head comparison of PV-10 combination therapy and monotherapy Keytruda."