With metastatic renal cell carcinoma (mRCC) reaching epidemic levels worldwide and contributing to comorbidities such as diabetes, cardiovascular disease, and other cancers, there is an increasing need for safer and more effective treatments. According to DelveInsight, the mRCC pipeline includes over 40 pharmaceutical and biotech companies developing more than 50 therapeutic candidates across various clinical and preclinical stages, highlighting significant innovation and dedication to addressing this major public health challenge.
DelveInsight’s report, “Metastatic Renal Cell Carcinoma Pipeline Insight 2025,” offers a comprehensive and strategic analysis of the R&D landscape, including clinical trial progress, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives. This report is an essential resource for researchers, healthcare investors, and decision-makers, providing insights into the evolving mRCC therapeutics market and the breakthroughs shaping its future.
Explore the Cutting-Edge Landscape of Metastatic renal cell carcinoma Drug Development
Key Takeaways from the Metastatic renal cell carcinoma Pipeline Report
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DelveInsight’s metastatic renal cell carcinoma (mRCC) pipeline report highlights a dynamic landscape with 40+ active companies developing over 50 therapeutic candidates for mRCC treatment.
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In February 2025, updated results from a Phase 1 trial (NCT05122546) presented at the 2025 Genitourinary Cancers Symposium demonstrated that combining CBM588 with cabozantinib (Cabometyx) and nivolumab (Opdivo) improved progression-free survival (PFS) and objective response rate (ORR) in mRCC patients, although it did not significantly increase Bifidobacterium species levels.
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In December 2024, Adicet Bio, Inc. (Nasdaq: ACET), a clinical-stage biotechnology company focused on allogeneic gamma delta T cell therapies for cancer and autoimmune diseases, announced dosing the first patient in its Phase 1 trial evaluating ADI-270 in patients with metastatic or advanced clear cell renal cell carcinoma (ccRCC).
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Key companies actively developing mRCC therapies include AstraZeneca, Genentech, Sumitomo Dainippon Pharma, Allogene Therapeutics, Nektar Therapeutics, Eli Lilly and Company, Xynomic Pharmaceuticals, AnewPharma, HUTCHMED, MedImmune, Incyte Corporation, NiKang Therapeutics, OncoC4, Inc., Nanobiotix, Aravive, Mirati Therapeutics Inc., BeiGene, Shanghai PerHum Therapeutics Co., Ltd., Akeso Biopharma, Novartis Pharmaceuticals, Vaccibody, SillaJen, Inc., Chongqing Precision Biotech Co., Ltd, Infinity Pharmaceuticals, Inc., SOTIO Biotech AG, Pfizer, Peloton Therapeutics, Inc., NeoTX Therapeutics Ltd., and others, all working to advance the mRCC treatment landscape.
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Promising pipeline candidates in various stages of development include Olaparib, Atezolizumab, TP-1454, and others.
Metastatic renal cell carcinoma Overview:
Renal cell carcinoma (RCC) is the most prevalent type of kidney cancer in adults, representing approximately 85% of kidney tumors. The disease often progresses silently, with only about 10% of patients exhibiting the classic symptoms of flank pain, hematuria (blood in the urine), and a palpable mass. Metastasis occurs in nearly one-third of RCC cases, commonly affecting the lungs, liver, bones, brain, and adrenal glands, though it can spread to almost any part of the body. Multiple organs are frequently involved.
Metastases may be present at the time of diagnosis or develop later, even after nephrectomy (surgical removal of the affected kidney). Around 20% to 50% of patients develop metastases post-nephrectomy, with a shorter interval to metastasis associated with a poorer prognosis. The overall outlook for patients with metastatic RCC remains poor, with a median survival of 6 to 12 months and only 10% to 20% surviving beyond two years.
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Metastatic renal cell carcinoma Pipeline Analysis
The Metastatic renal cell carcinoma pipeline insights report 2025, provides insights into:
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Provides comprehensive insights into key companies developing therapies in the Metastatic renal cell carcinoma Market.
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Categorizes Metastatic renal cell carcinoma therapeutic companies by development stage: early, mid, and late-stage.
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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.
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Reviews emerging Metastatic renal cell carcinoma drugs under development based on:
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Stage of development
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Metastatic renal cell carcinoma Route of administration
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Target receptor
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Monotherapy vs. combination therapy
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Metastatic renal cell carcinoma Mechanism of action
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Molecular type
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Offers detailed analysis of:
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Company-to-company and company-academia collaborations
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Metastatic renal cell carcinoma Licensing agreements
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Funding and investment activities supporting future Metastatic renal cell carcinoma market advancement.
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Unlock key insights into emerging Metastatic renal cell carcinoma therapies and market strategies here: https://www.delveinsight.com/report-store/metastatic-renal-cell-carcinoma-mrcc-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Metastatic renal cell carcinoma Emerging Drugs
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Olaparib: AstraZeneca
Olaparib is a potent and selective inhibitor of PARP1 and PARP2 enzymes. It works by targeting the defective DNA repair pathways in cancer cells with BRCA mutations, ultimately inducing cell death. Olaparib is approved for treating various BRCA-associated cancers, including ovarian, breast, pancreatic, and prostate cancers, with its initial FDA and EU approvals granted in December 2014. Currently, olaparib is being investigated in Phase II clinical trials for metastatic renal cell carcinoma.
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Atezolizumab: Genentech
Atezolizumab is a humanized IgG antibody that binds to PD-L1, preventing its interaction with PD-1 and B7-1. By blocking this pathway, it restores immune system activity, enhancing the body’s ability to target tumors, without inducing antibody-dependent cellular cytotoxicity. It is primarily used in patients whose tumors express PD-L1, who are unsuitable for platinum-based chemotherapy, or who have not responded to such treatments. Atezolizumab was FDA-approved on October 18, 2016, and is currently being evaluated in Phase III clinical trials for metastatic renal cell carcinoma.
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TP-1454: Sumitomo Dainippon Pharma
TP-1454 is an investigational oral therapy that activates the M2 isoform of pyruvate kinase (PKM2). It is currently undergoing a Phase 1/1b clinical trial for patients with advanced or metastatic solid tumors (NCT04328740) and represents the first PKM2 activator to be evaluated in cancer patients. Pyruvate kinase is a critical enzyme in glycolysis, with the PKM2 isoform playing a key role in the metabolic adaptations of cancer and immune cells, providing tumor cells with a metabolic advantage over the surrounding immune environment.
Metastatic renal cell carcinoma Pipeline Therapeutic Assessment
Metastatic renal cell carcinoma Assessment by Product Type
• Mono
• Combination
• Mono/Combination
Metastatic renal cell carcinoma By Stage
• 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
Metastatic renal cell carcinoma Assessment by Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
Metastatic renal cell carcinoma Assessment by Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
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Table of Contents
1. Report Introduction
2. Executive Summary
3. Metastatic renal cell carcinoma Current Treatment Patterns
4. Metastatic renal cell carcinoma - DelveInsight's Analytical Perspective
5. Therapeutic Assessment
6. Metastatic renal cell carcinoma Late-Stage Products (Phase-III)
7. Metastatic renal cell carcinoma Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Metastatic renal cell carcinoma Discontinued Products
13. Metastatic renal cell carcinoma Product Profiles
14. Metastatic renal cell carcinoma Key Companies
15. Metastatic renal cell carcinoma Key Products
16. Dormant and Discontinued Products
17. Metastatic renal cell carcinoma Unmet Needs
18. Metastatic renal cell carcinoma Future Perspectives
19. Metastatic renal cell carcinoma Analyst Review
20. Appendix
21. Report Methodology
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