Provectus Biopharmaceuticals Announces Presentation of Updated Data from Combination Therapy Trial of PV-10® and Keytruda® for Treatment of Checkpoint-Refractory Advanced Cutaneous Melanoma at Society for Melanoma Research (SMR) 2021

Rhea-AI Summary

Provectus announced updated results from its Phase 1b clinical trial of the cancer immunotherapy PV-10, in combination with Keytruda, for advanced cutaneous melanoma refractory to immune checkpoint blockade.

Key findings include a median overall survival of 34.1 months and a median progression-free survival of 4.9 months. The study reported a 5% complete response, a 26% objective response rate, and a 53% disease control rate. Treatment was mainly well-tolerated, with primarily grade 1-2 injection site reactions.

Positive

• 34.1 months median overall survival.
• 4.9 months median progression-free survival.
• 5% complete response, 26% objective response rate, and 53% disease control rate observed.
• PV-10 demonstrated ability to restore checkpoint blockade activity in refractory patients.

Negative

• None.

• 34.1 months median overall survival, 4.9 months median progression-free survival
• Best overall response (RECIST 1.1): 5% CR, 26% ORR, 53% DCR (19 patients)

KNOXVILLE, TN, Oct. 28, 2021 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that updated response, safety, and immune correlative data from the Company’s ongoing Phase 1b clinical trial of cancer immunotherapy PV-10 (rose bengal disodium), in combination with Keytruda (pembrolizumab), for the treatment of advanced cutaneous melanoma in patients refractory to immune checkpoint blockade (CB) (NCT02557321: first expansion cohort) will be presented at the SMR 2021 Virtual Congress (the Society for Melanoma Research annual meeting), which is being held online from October 28^th to 31^st.

A copy of the poster presentation is available on Provectus’ website at https://www.provectusbio.com/media/docs/publications/SMR-2021-PV-10-MM-1201-CI-Refractory.20Oct2021.pdf.

Highlights of the SMR 2021 presentation:

• Baseline characteristics
  • 22 patients; 19 evaluable for efficacy
  • 68% male; median age of 72 years (range 28-90); 50% Stage IV M1b-d
  • CB-refractory status: 9% CTLA-4, 32% PD-1, 59% CTLA-4+PD-1
• Safety (22 patients)
  • Principally grades 1-2 injection-site reactions for PV-10
  • Principally grades 1-3 immune-mediated reactions for Keytruda
• Best overall response (BOR) by RECIST 1.1 (19 patients)
  • 5% complete response (CR), 26% objective response rate (ORR), 53% disease control rate (DCR)
  • Prior PD-1 (6 patients): 50% ORR, 67% DCR
  • Prior CTLA-4+PD-1 (12 patients): 8% CR, 17% ORR, 50% DCR
• Durability of response
  • 4.9 months median progression-free survival (mPFS)
• Survival
  • 34.1 months median overall survival (mOS)
• Immune correlative assessment (6 patients)
  • Increases in damage-associated molecular pattern (DAMP) high mobility group box protein 1 (HMGB1) were consistent with the HMGB1 pattern of PV-10-treated CB-naïve melanoma patients
  • IFNγ expression of peripheral T cells demonstrates the induction of tumor-specific reactivity to HLA-matched cell lines, equivalent to that in CB-naïve melanoma patients
  • Immune correlative data substantiate the same PV-10 immune-mediated mechanism of action in CB-naïve monotherapy and CB-naïve and -refractory combination therapy melanoma patients
    

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, “Our melanoma drug development program has consistently and reproducibly shown PV-10’s unique innate and adaptive immune signaling mechanisms in single-agent and checkpoint blockade combination therapy clinical trials. To date, more than 50 patients have been treated with PV-10-Keytruda combination therapy for different melanoma indications. Current data notably demonstrate that cancer immunotherapy PV-10 can restore checkpoint blockade activity in patients who are refractory to this immunotherapy drug class.”

Prior study data is also available on Provectus’ website:

• Melanoma Bridge 2020, December 3-5: 14 evaluable patients, 7% CR, 29% ORR, 57% DCR,
• European Society for Medical Oncology (ESMO) Virtual Congress 2020, September 19-21: 11 evaluable patients, 9% CR, 36% ORR, 54% DCR, and
• SMR 2019 Congress, November 20-24: 8 evaluable patients, 25% ORR, 50% DCR, 4.9 months estimated mPFS, mOS not reached.
  

About PV-10

Intralesional (IL) administration of PV-10 for the treatment of solid tumor cancers can yield immunogenic cell death within hours of tumor injection, and induce tumor-specific reactivity in circulating T cells within days. This PV-10-induced functional T cell response may be enhanced and boosted in combination with immune checkpoint blockade (CB). In CB-refractory advanced cutaneous melanoma, PV-10 may restore disease-specific T cell function. IL PV-10 has been administered to over 450 patients with cancers of the skin and of the liver. It is administered under visual, tactile, or ultrasound guidance to superficial malignancies, and under CT or ultrasound guidance to visceral hepatic tumors. IL PV-10 is also undergoing preclinical study for pediatric solid tumor cancers (including neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma).

Systemic administration of PV-10 is undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory adult solid tumor cancers, and as a treatment for relapsed and refractory blood cancers.

Different formulations and routes of administration of PV-10 and rose bengal disodium are also undergoing clinical and/or preclinical study in virology, microbiology, ophthalmology, dermatology, and animal health.

About Provectus

Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company developing immunotherapy medicines for different disease areas based on an entire and wholly-owned family of small molecules called halogenated xanthenes. Information about the Company’s clinical trials can be found at the National Institutes of Health (NIH) registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's website at www.provectusbio.com.

Trademark

PV-10^® is registered trademark of Provectus Pharmatech, Knoxville, Tennessee, U.S.A.

Keytruda^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Kenilworth, New Jersey, U.S.A.

FORWARD-LOOKING STATEMENTS

The information in this press release may include “forward-looking statements,” within the meaning of U.S. securities legislation, relating to the business of Provectus and its affiliates, which are based on the opinions and estimates of Company management and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek,” “anticipate,” “budget,” “plan,” “continue,” “estimate,” “expect,” “forecast,” “may,” “will,” “project,” “predict,” “potential,” “targeting,” “intend,” “could,” “might,” “should,” “believe,” and similar words suggesting future outcomes or statements regarding an outlook.

The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated or that such agents as products will achieve any particular revenue levels.

Due to the risks, uncertainties, and assumptions inherent in forward-looking statements, readers should not place undue reliance on these forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof or as of the date specifically specified herein, and Provectus undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except in accordance with applicable securities laws. The forward-looking statements are expressly qualified by this cautionary statement.

Risks, uncertainties, and assumptions include those discussed in the Company’s filings with the SEC, including those described in Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 and Provectus’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2021.

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Contact:

Provectus Biopharmaceuticals, Inc.
Heather Raines, CPA
Chief Financial Officer
Phone: (866) 594-5999

FAQ

What are the latest results for PVCT in the clinical trial for melanoma?

Provectus reported a median overall survival of 34.1 months and a median progression-free survival of 4.9 months.

What response rates were observed in Provectus' melanoma trial?

The trial reported a 5% complete response rate, a 26% objective response rate, and a 53% disease control rate.

When were the results of PVCT's clinical trial presented?

The updated results were presented at the SMR 2021 Virtual Congress from October 28-31, 2021.

How many patients were involved in the PV-10 and Keytruda trial?

The trial involved 22 patients, with 19 evaluable for efficacy.