Melanoma Pipeline

DelveInsight’s, “Melanoma Pipeline Insight, 2025,”report provides comprehensive insights about 150+ companies and 170+ pipeline drugs in Melanoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Melanoma Treatment Landscape

Melanoma Overview

Melanoma is considered as a type of cancer that develops in the pigment-producing melanocyte cells. Anyway, tumors will grow in melanocytes of the skin in almost 90% of cases; it can also occur in melanocytes of the eye, internal organs, and mucosal membranes lining the gastrointestinal, respiratory and urogenital tracts. Melanoma is the third most common cutaneous malignancy after basal cell carcinoma and squamous cell carcinoma. Melanoma is the fifth most common malignancy in males and sixth most common malignancy in females. It is considered one of the most challenging diseases to treat with pharmacotherapy; melanoma drug development lagged than many other cancers, going on in decades with limited progress.

 Common melanoma metastasis sites include the lymph nodes, lungs, liver, bones and brain. Common symptoms of melanoma includes a new, unusual growth or a change in an existing mole the person may experience bigger mole diameter, darkening of the skin, mole color changes, or skin mole with irregular border, a skin sore that fails to heal, a spot or sore that becomes painful, itchy, or tender melanomas can occur anywhere on the body. During diagnosing with melanoma, doctor will do a skin exam and also the ABCDE examination.  If they think patient may have skin cancer, patient would need a biopsy to find out. Usually gets one of three types: Punch biopsy. This removes a round piece of skin. Excisional biopsy: doctor takes out the entire growth. Shave biopsy: doctor tries to shave off the entire growth. A doctor will look at the growth under a microscope to see how thick it is. Usually, a thicker tumor means there is a higher risk the cancer will spread. Additional tests are needed to determine whether the cancer is metastatic melanoma, or if there’s no visible primary tumor. 

There are various methods to diagnose the melanoma that includes sentinel lymph node biopsy, CT-Scans, MRI Scan, and PET scan, blood tests may be used to measure lactate dehydrogenase (LDH) before treatment. Other tests include blood chemistry levels and blood cell counts. Melanoma treatment depends on the current stage of the melanoma and general health of the person. Treatments for this disease includes melanoma surgery in early stages, surgery has a high probability of being able to cure the melanoma. Lymphadenectomy in cases where melanoma has spread, removal of the lymph nodes near the primary diagnosis site may be required this can prevent the spread to other areas of the body. Metastasectomy is used to remove small melanoma bits from organs. Targeted cancer therapy in this treatment option, drugs are used to attack specific cancer cells. Radiation therapy is also opted by many doctors and lastly the immunotherapy which is adopted by many biopharma companies for the treatment of melanoma.

"Melanoma Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Melanoma pipeline landscape is provided which includes the disease overview and Melanoma treatment guidelines. The assessment part of the report embraces, in depth Melanoma commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Melanoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Melanoma Report Highlights and Recent Developments

• The companies and academics are working to assess challenges and seek opportunities that could influence Melanoma R&D. The therapies under development are focused on novel approaches to treat/improve Colorectal Cancer.
• In August 2025, Regeneron Pharmaceuticals highlighted its PD-1 inhibitor Libtayo as the standard of care for advanced cutaneous squamous cell carcinoma (CSCC), with ongoing research in melanoma and multiple myeloma.
• In February 2025, Bristol Myers Squibb announced that the phase 3 RELATIVITY-098 trial of Opdualag (nivolumab and relatlimab-rmbw) for adjuvant treatment of completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival (RFS). The safety profile of Opdualag was consistent with the known profiles of nivolumab and relatlimab.

 

Melanoma Emerging Drugs Analysis

This segment of the Melanoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

Melanoma Emerging Drugs

• IO102 IO103 : IO Biotech

IO102-IO103 is an investigational immune-modulating therapeutic cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1). IDO and/or PD-L1 are overexpressed by many types of solid tumors and immune-suppressive cells (Tregs and TAMs) in the TME. The company is developing this vaccine based on its T-win® vaccine platform. Currently it is in Phase III stage of clinical trial evaluation to treat Melanoma.

 

• mRNA 4157: Merck/Moderna Therapeutics

mRNA-4157/V940 is a novel investigational messenger ribonucleic acid (mRNA)-based personalized cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed to stimulate an immune response by generating specific T cell responses based on the unique mutational signature of a patient's tumor. The drug is been developed jointly by Moderna & Merck.  Currently being evaluated in the Phase III studies.

 

• BNT111: BioNTech SE

BNT111 is an intravenous therapeutic cancer immunotherapy candidate encoding a fixed set of four cancer-specific antigens optimized for immunogenicity and delivered as RNA-lipoplex formulation. The drug induces novel antigen-specific anti-tumor immune responses and enhances pre-existing immune responses against the encoded melanoma-associated antigens. The drug is in Phase II stage of clinical trials.

 

• TILT 123: TILT Biotherapeutics LLC

TILT-123 is a human 5/3 chimeric adenovirus that has been engineered to encode human Tumor Necrosis Factor alpha (hTNFa) and human Interleukin 2 (hIL-2) cytokines. It is optimized to generate an anti-cancer immune response by boosting the activity of T-cells and also stimulating other arms of the innate and adaptive immune system. TILT-123 can be administered by intravenous, intratumoral, intraperitoneal and intrapleural injection. The drug is in Phase I stage of clinical trials.

Comparison of Emerging Drugs under Development
Drug Name	Company name	MoA	RoA	Phase	Indication
Fianlimab + Cemiplimab	Regeneron Pharmaceuticals	LAG-3 inhibitor	IV	III	Advanced melanoma
IO102-IO103	IO Biotech	IDO1 & PD-1 inhibitor	Subcutaneous	III	First-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma
BS001	Binhui Biopharmaceutical	Oncolysis	Intratumoral	I	Melanoma with αPD-1 failure
SGN-BB228	Pfizer	CD228 inhibitor	IV	I	Advanced melanoma

Discover the latest Melanoma Market insights, epidemiology, and 2034 forecasts to make informed decisions for your healthcare strategies today.

Melanoma: Therapeutic Assessment

This segment of the report provides insights about the different Melanoma drugs segregated based on following parameters that define the scope of the report, such as:

• Major  Players in Melanoma

There are approx. 150+ key companies which are developing the therapies for Colorectal Cancer. The companies which have their Melanoma drug candidates in the most advanced stage, i.e. phase III include, IO Biotech

 

Melanoma Clinical trials Phases

Delve Insight’s report covers around 170+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

 

Route of Administration

Melanoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Parenteral
• intravenous
• Subcutaneous
• Topical.

 

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

 

Melanoma Pipeline Development Activities 

The Melanoma pipeline report provides insights into Melanoma clinical trials within candidates in phase III II, I, preclinical and discovery stage. It also analyses Melanoma therapeutic drugs key players involved in developing key drugs.

 

Melanoma Pipeline Development Activities

The rMelanoma pipelineeport covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Melanoma drugs.

Melanoma Pipeline Report Insights

• Melanoma Pipeline Analysis
• Melanoma Therapeutic Assessment
• Melanoma Unmet Needs
• Impact of Melanoma Drugs

Melanoma Report Assessment

• Melanoma Pipeline Product Profiles
• Melanoma Therapeutic Assessment
• Melanoma Pipeline Assessment
• Inactive Melanoma drugs assessment
• Melanoma Unmet Needs

Key Questions Answered In The Melanoma Pipeline Report- 

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Melanoma drugs?
• How many Melanoma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Melanoma?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Melanoma therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Melanoma and their status?
• What are the key designations that have been granted to the emerging drugs?