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Advanced Melanoma Pipeline

DelveInsight’s Advanced Melanoma Pipeline Insightpresents a comprehensive evaluation of the evolving research landscape, covering more than 55 pharmaceutical and biotech companies and over 60 pipeline candidates currently under development for advanced melanoma. The report features in-depth profiles of therapies across both clinical and preclinical stages, with systematic assessment based on therapy type, development phase, route of delivery, and molecular classification. It also identifies programs that have been halted or discontinued within this therapeutic area.

Discover the latest scientific breakthroughs and emerging treatment strategies transforming the advanced melanoma pipeline. View the full report here: Advanced Melanoma Pipeline Outlook

Key Takeaways from the Advanced Melanoma Pipeline Report

• Innovent Biologics (Suzhou) Co. Ltd. commenced a Phase II clinical trial in May 2025 to evaluate the safety profile, tolerability, and therapeutic potential of IBI363 in patients with advanced melanoma.
• Iovance Biotherapeutics Inc. initiated a Phase III open-label, multicenter study comparing lifileucel in combination with pembrolizumab versus pembrolizumab monotherapy in patients with untreated, unresectable, or metastatic melanoma. Participants experiencing confirmed disease progression on pembrolizumab may transition to lifileucel alone.
• Anaveon AG carried out a clinical study examining ANV419 as a standalone therapy and in combination with anti-PD-1 or anti-CTLA-4 agents in advanced cutaneous melanoma. While Part 1 advanced, interim analyses indicated that efficacy thresholds for Parts 2 and 3 were not achieved.
• iOnctura initiated a study enrolling 85 adult patients with advanced or metastatic uveal melanoma who had progressed following at least one prior immunotherapy regimen, with measurable disease confirmed under RECIST v1.1 guidelines.
• Iovance Biotherapeutics Inc. launched a first-in-human Phase I trial of IOV-3001, an antibody–IL-2 fusion construct. The study includes two cohorts in which IOV-3001 is administered either before or after lifileucel, replacing aldesleukin.
• The current pipeline includes more than 55 active developers advancing over 60 therapeutic candidates for advanced melanoma.
• Major players shaping the landscape include Replimune, IO Biotech, BioNTech SE, Perspective Therapeutics, Agenus Inc., Dragonfly Therapeutics, Iovance Biotherapeutics, Novartis, AstraZeneca, Exelixis, Immunocore, BeiGene, Biocad, Merck Sharp & Dohme, Genentech, Amgen, and others.
• Prominent emerging therapies highlighted in the pipeline include Tebentafusp, T3011, IMC-F106C, Relatlimab, HLX208, DCB-BO1301, Pembrolizumab, among several others.

Stay informed on ongoing clinical developments in advanced melanoma: Advanced Melanoma Treatment Drugs

Advanced Melanoma Overview

Advanced melanoma represents an aggressive and life-threatening form of skin cancer in which malignant cells metastasize from the primary tumor to distant organs, including the lungs, liver, brain, and skeletal system. It is generally categorized as unresectable Stage III or metastatic Stage IV disease. This condition is marked by rapid disease progression, frequent relapse, and substantial biological diversity, complicating treatment decisions. Recent progress in immunotherapies, targeted agents, and combination treatment strategies has significantly extended survival. Current research efforts continue to emphasize innovative mechanisms of action, biomarker-driven strategies, and personalized therapies to address resistance and improve durable disease control.

Emerging Advanced Melanoma Drug Profiles

Vusolimogene oderparepvec (RP1) – Replimune

RP1 is an oncolytic herpes simplex virus genetically modified to express GALV-GP R- and GM-CSF, enhancing tumor cell destruction, immune activation, and systemic antitumor responses. When combined with nivolumab, the therapy has received FDA Priority Review and is presently in the registration stage.

IO102-IO103 – IO Biotech

This therapeutic regimen combines two T-win® vaccines designed to activate T-cell responses against IDO1 and PD-L1. Clinical studies have demonstrated strong and sustained responses without an increase in severe toxicity. The therapy has been granted FDA Breakthrough Therapy Designation and is currently undergoing Phase III development.

BNT111 – BioNTech SE

BNT111 is an mRNA-based cancer immunotherapy encoding four melanoma-associated antigens, developed for patients with PD-(L)1-refractory unresectable Stage III or IV melanoma. The candidate has received FDA Fast Track and Orphan Drug designations and is advancing through Phase II clinical trials.

VMT01 – Perspective Therapeutics

VMT01 is a targeted radiopharmaceutical engineered to deliver lead-212 to melanoma cells expressing MC1R. Its dual antitumor activity involves direct radiation-induced cell death along with immune-mediated tumor elimination. The therapy is currently being evaluated in Phase I/II studies and holds FDA Fast Track status.

Botensilimab – Agenus Inc.

Botensilimab is a next-generation anti-CTLA-4 antibody designed to stimulate both innate and adaptive immune responses, particularly in immunologically “cold” tumors resistant to current checkpoint inhibitors. The agent is presently under evaluation in Phase I clinical trials.

Key Analytical Insights from the Report

• In-depth profiling of companies developing advanced melanoma therapies, categorized by early-, mid-, and late-stage development.
• Detailed evaluation of pipeline candidates based on mechanism of action, molecular class, route of administration, and use as monotherapy or in combination regimens.
• Comprehensive review of active, inactive, and discontinued development programs.
• Extensive analysis of strategic collaborations, licensing deals, and funding trends influencing future pipeline evolution.

Explore the complete range of marketed and investigational therapies here: New Advanced Melanoma Drugs

Advanced Melanoma Companies Featured

Key organizations included in the report are Replimune, IO Biotech, BioNTech SE, Perspective Therapeutics, Agenus Inc., Dragonfly Therapeutics, Olatec Therapeutics, Iovance Biotherapeutics, Novartis, AstraZeneca, Exelixis, Transgene, Immunocore, BeiGene, Biocad, Shandong Boan Biotechnology, Merck Sharp & Dohme, Genentech, Aulos Bioscience, Multitude Therapeutics, Amgen, and several others.

Advanced Melanoma Pipeline Segmentation by Route of Administration

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Advanced Melanoma Pipeline by Molecule Type

• Recombinant fusion proteins
• Small-molecule drugs
• Monoclonal antibodies
• Peptides
• Polymers
• Gene-based therapies

Gain insights into the key drivers, challenges, and unmet needs shaping therapy development: Advanced Melanoma Market Drivers and Barriers

Advanced Melanoma Pipeline Report Scope

• Global market coverage
• Company coverage includes Replimune, IO Biotech, BioNTech SE, Perspective Therapeutics, Agenus Inc., Dragonfly Therapeutics, Olatec Therapeutics LLC, Iovance Biotherapeutics, Novartis, AstraZeneca, and many others
• Featured therapies include Tebentafusp, T3011, IMC-F106C, Relatlimab, HLX208, DCB-BO1301, Pembrolizumab, and more
• Evaluation based on:
  • Therapy Type: Monotherapy, Combination, Hybrid
  • Development Stage: Discovery through Phase III

Download the full analysis covering companies, key assets, and unmet needs: Advanced Melanoma Companies, Key Products, and Unmet Needs

About DelveInsight

DelveInsight is a leading life sciences market research and business consulting firm, offering syndicated reports and customized solutions to companies in the healthcare sector. Leveraging deep analytical expertise, primary research, and expert insights, DelveInsight delivers actionable intelligence to stakeholders worldwide.

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