Leiomyosarcoma - Pipeline Insight, 2025

This “Leiomyosarcoma - Pipeline Insight, 2025,” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Leiomyosarcoma 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.

Leiomyosarcoma Understanding

Leiomyosarcoma: Overview

Leiomyosarcoma (LMS) is a rare and aggressive type of cancer that originates from smooth muscle cells, which are the involuntary muscles responsible for various automatic functions in the body, such as the movement of the intestines, contraction of blood vessels, and actions of the uterus. These tumors can arise in any organ containing smooth muscle, with common sites including the uterus, gastrointestinal tract, retroperitoneum (the area behind the abdominal cavity), and blood vessels. Although LMS accounts for only 10-20% of all soft tissue sarcomas, it poses significant challenges due to its aggressive nature and poor prognosis.

The symptoms of leiomyosarcoma vary widely depending on the tumor's location. Uterine LMS may present with abnormal uterine bleeding, pelvic pain, and the presence of a palpable mass in the pelvic region. When LMS develops in the gastrointestinal tract, patients might experience abdominal pain, nausea, vomiting, weight loss, and sometimes gastrointestinal bleeding. Retroperitoneal LMS can cause abdominal pain, a noticeable mass, and symptoms related to the compression of nearby organs. Cutaneous LMS, which occurs in the skin, usually appears as a firm, painless lump.

Diagnosing leiomyosarcoma involves a combination of clinical evaluation, imaging studies, and histopathological examination. Imaging techniques such as magnetic resonance imaging (MRI) and computed tomography (CT) scans are essential for determining the size, location, and extent of the tumor. A definitive diagnosis is typically confirmed through a biopsy, where a tissue sample from the suspected tumor is examined under a microscope to identify the characteristic features of LMS. Immunohistochemical staining is often used to distinguish LMS from other types of soft tissue sarcomas and benign smooth muscle tumors.

Treatment for leiomyosarcoma generally involves surgical resection of the tumor, which is the primary mode of treatment, especially if the tumor is localized and can be completely removed. However, due to the aggressive nature of LMS and its tendency to recur, additional treatments such as radiation therapy and chemotherapy may be necessary. The effectiveness of chemotherapy varies, and it is often used in cases where the tumor is inoperable or has metastasized. Recent advances in targeted therapies and immunotherapies are also being explored as potential treatment options for LMS.

The prognosis for patients with leiomyosarcoma depends on several factors, including the tumor's size, location, stage at diagnosis, and the success of surgical resection. Unfortunately, LMS is known for its high recurrence rate and potential for metastasis, which significantly impacts long-term survival. Regular follow-up and monitoring are crucial for managing this disease, as early detection of recurrence can lead to more effective treatment options. Despite its challenges, ongoing research and clinical trials continue to seek better understanding and improved therapies for those affected by this formidable cancer.

'Leiomyosarcoma - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Leiomyosarcoma pipeline landscape is provided which includes the disease overview and Leiomyosarcoma treatment guidelines. The assessment part of the report embraces, in depth Leiomyosarcoma 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, Leiomyosarcoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Leiomyosarcoma R&D. The therapies under development are focused on novel approaches to treat/improve Leiomyosarcoma.

Leiomyosarcoma Emerging Drugs Chapters

This segment of the Leiomyosarcoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.

Leiomyosarcoma Emerging Drugs

ADI PEG20: Polaris Group

ADI-PEG 20 is a first-in-class therapeutic approach to deplete arginine and starve cancer cells. Because arginine is one of the 20 amino acids that are essential for protein synthesis and survival of cells, some cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, which causes arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Currently, it is in Phase III stage of clinical trial evaluation to treat Leiomyosarcoma.

OR2805: OncoResponse

OR2805 is a fully human monoclonal antibody that targets CD163, an immune-suppressive receptor highly expressed on tumor-associated macrophages (TAMs). It was discovered using B cells derived from an elite responder to checkpoint inhibitor (CPI) therapy and is designed to reverse the immunosuppressive effect of TAMs, enhancing anti-tumor T-cell responses. In preclinical studies, OR2805 showed significant anti-tumor activity in lung cancer xenograft models in humanized mice and relieved the suppressive effect of M2c macrophages in coculture assays. OR2805 is currently being evaluated in a Phase I/II clinical trial to assess its safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with Leiomyosarcoma. The trial includes a dose-escalation phase, expansion cohorts, and a biology cohort to evaluate potential biomarkers. OR2805 has the potential to improve anti-tumor T-cell responses by reversing the immunosuppressive effect of TAMs, making it a promising therapeutic strategy for treating advanced cancers.

Leiomyosarcoma: Therapeutic Assessment

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

Major Players in Leiomyosarcoma

There are approx. 10+ key companies which are developing the therapies for Leiomyosarcoma. The companies which have their Leiomyosarcoma drug candidates in the most advanced stage, i.e. phase III include, Polaris Group.

Phases

The report covers around 10+ 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

Leiomyosarcoma 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.

Leiomyosarcoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Leiomyosarcoma therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

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

Leiomyosarcoma Report Insights

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

Leiomyosarcoma Report Assessment

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

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Leiomyosarcoma drugs?
• How many Leiomyosarcoma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Leiomyosarcoma?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Leiomyosarcoma 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 Leiomyosarcoma and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Merck
• Advenchen Laboratories
• Trillium Therapeutics
• PTC Therapeutics
• PharmaMar
• Philogen
• EMD Serono
• Incyte Corporation
• Clovis Oncology, Inc.

Key Products

• Avelumab
• AL3818
• Pembrolizumab
• TTI-621
• PTC596
• ET-743
• L19-hTNF
• M6620
• Itacitinib
• Rucaparib

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