Melanoma refers to a type of skin cancer that is primarily caused by exposure to ultraviolet light (UV). They represent only 1% of all skin cancers. However, cancer-related death as a result of melanoma is a significant cause of concern. If not detected or treated early, melanoma can turn into a metastatic disease. Unresectable melanoma or metastatic melanoma is considered an aggressive form of cancer that can be life-threatening. This indicates the urgent need for clinical research efforts to introduce effective treatment options for patients suffering from unresectable melanoma.
The detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to unresectable melanoma are covered.
In February 2024, Amtagvi (lifileucel) developed by Iovance Biotherapeutics Inc., the first cellular therapy for the treatment of unresectable or metastatic melanoma, received regulatory approval from the U.S. Food and Drug Administration. Moreover, the increasing research into identifying new genetic mutations and molecular pathways involved in the progression of unresectable melanoma that can be targeted with novel therapies is poised to lead to the expansion of the drug pipeline in the coming years.
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Report Coverage
The Unresectable Melanoma Drug Pipeline Report by the publisher gives comprehensive insights into unresectable melanoma drugs currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for unresectable melanoma. The report includes the analysis of over 100 pipeline drugs and 50+ companies . It will include an analysis based on efficacy and safety measure outcomes published for the trials including their adverse effects on patients suffering from unresectable melanoma.The detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to unresectable melanoma are covered.
Unresectable Melanoma Drug Pipeline Outlook
Historically, melanoma has posed a formidable challenge in the field of oncology, especially in its advanced stages. The introduction of targeted therapies and immune checkpoint inhibitors (ICIs) transformed the treatment landscape for the disease in the past decade. Further, the development of immune checkpoint inhibitors designed to target CTLA-4, PD-1, and PD-L1, among others, substantially enhanced the clinical outcomes for unresectable or advanced melanoma. However, significant challenges still remain such as the management of rare melanoma subtypes or the resistance to current treatments in certain cases.In February 2024, Amtagvi (lifileucel) developed by Iovance Biotherapeutics Inc., the first cellular therapy for the treatment of unresectable or metastatic melanoma, received regulatory approval from the U.S. Food and Drug Administration. Moreover, the increasing research into identifying new genetic mutations and molecular pathways involved in the progression of unresectable melanoma that can be targeted with novel therapies is poised to lead to the expansion of the drug pipeline in the coming years.
Unresectable Melanoma - Drug Pipeline Therapeutic Assessment
This section of the report covers the analysis of unresectable melanoma drugs based on several segmentations including:By Phase
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
By Drug Class
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
By Route of Administration
- Oral
- Parenteral
- Others
Unresectable Melanoma - Pipeline Assessment Segmentation, By Phases
The report covers phase I, phase II, phase III, phase IV, and early phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to analysis, phase II covers a major share of the total clinical trials for unresectable melanoma. There are around 70 drugs in phase II for unresectable melanoma.Unresectable Melanoma - Pipeline Assessment Segmentation, By Drug Classes
The drug molecules categories covered under unresectable melanoma pipeline analysis include recombinant fusion proteins, small molecules, monoclonal antibodies, peptides, polymer, and gene therapy. The treatment for unresectable melanoma varies depending on the stage of the disease, the genetic mutations present in the tumor, the previous treatments, and the patient's health. The report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for unresectable melanoma.Unresectable Melanoma Clinical Trials Assessment - Competitive Dynamics
The report for the unresectable melanoma drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in unresectable melanoma clinical trials:- Bristol-Myers Squibb
- Pfizer
- Novartis Pharmaceuticals
- Hoffmann-La Roche
- Regeneron Pharmaceuticals
- Amgen
- IO Biotech
- Biocad
- Iovance Biotherapeutics, Inc.
- R-Pharm
Unresectable Melanoma - Pipeline Drugs Profile
Major drugs currently in the pipeline are as follows:
Drug: IO102-IO103, Drug: Pembrolizumab
The international, randomized, 2-arm study is designed to assess the safety and efficacy profile of IO102-IO103 in combination with pembrolizumab for the treatment of metastatic (advanced) melanoma or previously untreated unresectable melanoma. The trial, enrolling 400+ participants, is sponsored by IO Biotech and is currently under phase III.Drug: RPH-075, Drug: Keytruda
The objective of the double-blind, randomized study is to compare the safety, efficacy, and immunogenicity of RPH-075 and Keytruda® in unresectable or metastatic skin melanoma patients. The trial is sponsored by R-Pharm and is currently under phase III.Drug: RO7247669
Sponsored by Hoffmann-La Roche, this randomized, open-label, multicenter, phase II study aims to evaluate the pharmacokinetics (PK), and pharmacodynamics along with the efficacy and safety profile of two dose levels of the drug RO7247669 in around 80 participants with unresectable or metastatic melanoma.Biological: Lorigerlimab
This open-label Phase I study, sponsored by MacroGenics, is investigating the pharmacokinetics, pharmacodynamics, safety, tolerability, and preliminary antitumor activity of the biological candidate lorigerlimab in an estimated 162 patients with unresectable or metastatic neoplasms.Reasons To Buy This Report
The Unresectable Melanoma Drug Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for unresectable melanoma. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into market trends, regulatory environments, and potential growth opportunities within unresectable melanoma pipeline insights.Key Questions Answered in the Unresectable Melanoma - Pipeline Assessment Report
- What is the current landscape of unresectable melanoma pipeline drugs?
- How many companies are developing unresectable melanoma drugs?
- How many phase III and phase IV drugs are currently present in unresectable melanoma pipeline drugs?
- Which companies/institutions are leading the unresectable melanoma drug development?
- What is the efficacy and safety profile of unresectable melanoma pipeline drugs?
- What are the opportunities and challenges present in the unresectable melanoma drug pipeline landscape?
- Which company is conducting major trials for unresectable melanoma drugs?
- What geographies are covered for unresectable melanoma clinical trials?
- What are emerging trends in unresectable melanoma clinical trials?
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Table of Contents
1 Preface
3 Overview of Unresectable Melanoma
4 Patient Profile: Unresectable Melanoma
5 Unresectable Melanoma: Epidemiology Snapshot
6 Unresectable Melanoma: Market Dynamics
7 Unresectable Melanoma: Key Facts Covered
8 Unresectable Melanoma, Drug Pipeline Assessment
9 Drug Pipeline Comparative Analysis
10 Unresectable Melanoma Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
11 Unresectable Melanoma Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
12 Unresectable Melanoma Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
13 Unresectable Melanoma Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
14 Unresectable Melanoma, Key Drug Pipeline Companies
