PD-1/PD-L1阻害薬 - 競合情勢（2024年）

当レポートでは、PD-1/PD-L1阻害薬市場について調査分析し、180以上の企業と200以上の医薬品に関する包括的な考察を提供しています。また、製品タイプ、段階、投与経路、分子タイプごとに治療薬を評価し、休止中のパイプライン製品にも焦点を当てています。

目次

イントロダクション

エグゼクティブサマリー

PD-1/PD-L1阻害薬：概要

• PD-1（Programmed Death-1）
• PD-L1（Programmed Death Ligand-1）
• PD-1/PD-L1阻害薬の作用機序
• PD-1/PD-L1阻害薬の重要性

PD-1/PD-L1阻害薬 - 分析的観点：詳細な商業的評価

• PD-1/PD-L1阻害薬の提携の分析：企業別

競合情勢

• 企業の比較評価（治療法別、開発段階別、技術別）

治療法の評価

• 評価：製品タイプ別
• 評価：段階別、製品タイプ別
• 評価：投与経路別
• 評価：段階別、投与経路別
• 評価：分子タイプ別
• 評価：段階別、分子タイプ別

PD-1/PD-L1阻害薬：企業と製品のプロファイル（上市済みの治療薬）

Merck Sharp & Dohme LLC

• 企業の概要

キイトルーダ

• 製品の説明
• 研究開発活動
• 製品開発活動

PD-1/PD-L1阻害薬：企業と製品のプロファイル（パイプライン治療薬）

後期の製品（フェーズIII）

• 比較分析

BIOCAD

• 企業の概要

プロルゴリマブ

• 製品の説明
• 研究開発活動
• 製品開発活動

中期の製品（フェーズII）

• 比較分析

初期の製品（フェーズI）

• 比較分析

Laekna Therapeutics

• 企業の概要

FAZ 053

• 製品の説明
• 研究開発活動
• 製品開発活動

前臨床、創薬段階の製品

• 比較分析

休止中の製品

• 比較分析

PD-1/PD-L1阻害薬 - アンメットニーズ

PD-1/PD-L1阻害薬 - 市場の促進要因と障壁

付録

List of Tables

• Table 1 Total Products for PD-1 and PD-L1 Inhibitors
• Table 2 Late Stage Products
• Table 3 Mid Stage Products
• Table 4 Early Stage Products
• Table 5 Pre-clinical & Discovery Stage Products
• Table 6 Assessment by Product Type
• Table 7 Assessment by Stage and Product Type
• Table 8 Assessment by Route of Administration
• Table 9 Assessment by Stage and Route of Administration
• Table 10 Assessment by Molecule Type
• Table 11 Assessment by Stage and Molecule Type
• Table 12 Inactive Products

List of Figures

• Figure 1 Total Products for PD-1 and PD-L1 Inhibitors
• Figure 2 Late Stage Products
• Figure 3 Mid Stage Products
• Figure 4 Early Stage Products
• Figure 5 Preclinical and Discovery Stage Products
• Figure 6 Assessment by Product Type
• Figure 7 Assessment by Stage and Product Type
• Figure 8 Assessment by Route of Administration
• Figure 9 Assessment by Stage and Route of Administration
• Figure 10 Assessment by Molecule Type
• Figure 11 Assessment by Stage and Molecule Type
• Figure 12 Inactive Products

DelveInsight's, "PD-1 and PD-L1 Inhibitors - Competitive landscape, 2024," report provides comprehensive insights about 180+ companies and 200+ drugs in PD-1 and PD-L1 Inhibitors Competitive landscape. It 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

PD-1 and PD-L1 Inhibitors: Understanding

PD-1 and PD-L1 Inhibitors: Overview

PD-1 (programmed cell death protein 1) is found on the surface of cancer cells. It is used by tumors to evade the immune system so blocking its action enables the body to attack and kill cancer. T cells constantly monitor our body for abnormal cells and eliminate them before they can turn into cancer. A key step in tumor development is finding ways to avoid or shut down the immune system. When a T cell becomes activated, it also needs a stop signal in order to make sure it does not get over-activated. This can be done through inhibitory receptors, such as PD-1. After activation, T cells increase the expression of PD-1 on their surface, allowing them to receive a shutdown signal. Tumor cells take advantage of this system by expressing binding partners of PD-1, prematurely shutting down the T cells. Programmed death 1 (PD-1) proteins bind with two ligands, namely Programmed death-ligand 1 (PD-L1) and Programmed death-ligand 2 (PD-L2).

Programmed death-ligand 1 (PD-L1) in humans is encoded by the CD274 gene. PD-L1 is also known as cluster of differentiation 274 (CD274). It is a 40 kDa type 1 transmembrane protein that plays a major role in suppressing the immune system during particular events, such as pregnancy, tissue allograft, autoimmune disease, and other disease states such as hepatitis. Normally the immune system reacts to foreign antigens where there is some accumulation in the lymph nodes or spleen which triggers a proliferation of antigen-specific CD8+ T cell. PD-L1 binds to its receptor, PD-1, found on activated T cells, B cells, and myeloid cells to modulate activation or inhibition. PD-1 is a checkpoint protein on immune cells called T cells. It normally acts as a type of "off switch" that helps keep the T cells from attacking other cells in the body. It does this when it attaches to PD-L1, a protein on some normal (and cancer) cells. When PD-1 binds to PD-L1, it basically tells the T cell to leave the other cell alone. Some cancer cells have large amounts of PD-L1, which helps them hide from an immune attack. Monoclonal antibodies that target either PD-1 or PD-L1 can block this binding and boost the immune response against cancer cells. These drugs have shown a great deal of promise in treating certain cancers. PD-1 inhibitors: These drugs are given by IV (intravenously). Examples of drugs that target PD-1 include: Pembrolizumab (Keytruda), Nivolumab (Opdivo), Cemiplimab (Libtayo). These drugs have been shown to be helpful in treating several types of cancer, and new cancer types are being added as more studies show these drugs to be effective. Examples of drugs that target PD-L1 include: Atezolizumab (Tecentriq), Avelumab (Bavencio) and Durvalumab (Imfinzi).

Report Highlights:

• In June 2023, Qilu Pharmaceutical presented trials in Progress poster presentation on QL1706 (iparomlimab/tuvonralimab), an innovative bifunctional antibody for immunotherapy, in two Phase III non-small cell lung carcinoma (NSCLC) clinical studies at the 2023 American Society of Clinical Oncology Annual Meeting (ASCO 2023).
• In May 2023, Summit Therapeutics announced that the first United States-based patient has been enrolled in the Phase III HARMONi study. HARMONi is a Phase III multiregional, randomized, double-blinded study. The study will evaluate the efficacy and safety of ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) such as osimertinib.
• In May 2023, Gilead Sciences and Arcus Biosciences announced updated results from an interim analysis of the ARC-7 study in patients with first-line, metastatic non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) 50% without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations. Progression-free survival curves showed early separation of both domvanalimab-containing arms from the zimberelimab arm, which was consistently maintained, and supports the potential therapeutic benefit of inhibiting the TIGIT pathway.
• In April 2023, Enlivex Therapeutics Ltd., announced a clinical collaboration with BeiGene to evaluate the safety and efficacy of Allocetra™, an investigational macrophage-reprogramming cell therapy, in combination with tislelizumab, an anti-PD-1 immune checkpoint inhibitor, for the treatment of patients with advanced-stage solid tumors.
• In January 2023, CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), announced that CARsgen's execution of a collaboration agreement with F. Hoffmann-La Roche Ltd ("Roche") to evaluate CARsgen's investigational drug AB011, in combination with atezolizumab, Roche's PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with gastric or gastroesophageal junction carcinoma . Under the terms of the agreement, Roche will be responsible for operation and conduct of the trial while both companies co-share the costs of the AB011 treatment arms in the study.
• In December 2022, Akeso announced a collaboration and license agreement (the "Agreement") with Summit Therapeutics Inc., to out-license its breakthrough bispecific antibody, ivonescimab (PD-1/VEGF, AK112) for development and commercialization in the United States, Canada, Europe, and Japan (the "License Territories"). In addition, the Company will co-brand the product in the License Territories.
• In September 2022, Merck announced that KEYTRUDA, Merck's anti-PD-1 therapy, received four new approvals from Japan's Ministry of Health, Labor and Welfare (MHLW):
  • KEYTRUDA in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery for patients with hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer at high risk of recurrence, based on data from the KEYNOTE-522 trial;
  • KEYTRUDA as monotherapy for the adjuvant treatment of certain patients with renal cell carcinoma (RCC) at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions, based on data from the KEYNOTE-564 trial
  • KEYTRUDA in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with advanced or recurrent cervical cancer with no prior chemotherapy who are not amenable to curative treatment, based on data from the KEYNOTE-826 trial
  • KEYTRUDA as monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection, based on data from the KEYNOTE-716 trial

PD-1 and PD-L1 Inhibitors: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Merck

• Merck, known as MSD outside of the United States and Canada, are unified around the purpose: company uses the power of leading-edge science to save and improve lives around the world. Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. Merck also continue to strengthen the portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers.
• Product Description: KEYTRUDA
• Pembrolizumab is the active ingredient of KEYTRUDA, which is a humanized monoclonal antibody that binds to the programmed cell death - 1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including anti-tumor immune response. Pembrolizumab is an IgG4 kappa immunoglobulin and has an approximate 149 kDa molecular weight. KEYTRUDA has received approval for advanced melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer, classical Hodgkin lymphoma, microsatellite-instability-high cancer, Primary Mediastinal Large B-Cell Lymphoma (PMBCL), Small Cell Lung Cancer (SCLC), Microsatellite Instability-High Cancer, Gastric Cancer, Esophageal Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Endometrial Carcinoma and advanced urothelial bladder cancer. In January 2020, Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck's anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. In January 2023, the Food and Drug Administration (FDA) approved pembrolizumab (KEYTRUDA, Merck) for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a >=4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

2. Company Overview: AstraZeneca

• AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. AstraZeneca is boldly pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure.
•  
• Product Description: IMFINZI
• IMFINZI (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor's immune-evading tactics and releasing the inhibition of immune responses.
• IMFINZI is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiation therapy based on the PACIFIC Phase III trial. IMFINZI is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage SCLC based on the CASPIAN Phase III trial. In an exploratory analysis in 2021, updated results from the CASPIAN trial showed IMFINZI plus chemotherapy tripled patient survival at three years versus chemotherapy alone. Additionally, IMFINZI is approved in combination with a short course of IMJUDO (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC in the US, EU and Japan based on the POSEIDON Phase III trial. In addition to its indications in lung cancer, IMFINZI is also approved in combination with chemotherapy in locally advanced or metastatic biliary tract cancer in the US, EU, Japan and several other countries; in combination with IMJUDO in unresectable hepatocellular carcinoma in the US, EU and Japan; and in previously treated patients with advanced bladder cancer in several countries. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with bladder cancer, several gastrointestinal (GI) cancers, ovarian cancer, endometrial cancer and other solid tumors.
•  
• PD-1 AND PD-L1 Inhibitors: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: AstraZeneca

• AstraZeneca is an Anglo-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. It has been involved in developing the Oxford-AstraZeneca COVID-19 vaccine.
• The company was founded in 1999 through the merger of the Swedish Astra AB and the British Zeneca Group (itself formed by the demerger of the pharmaceutical operations of Imperial Chemical Industries in 1993). Since the merger it has been among the world's largest pharmaceutical companies and has made numerous corporate acquisitions, including Cambridge Antibody Technology (in 2006), MedImmune (in 2007), Spirogen (in 2013) and Definiens (by MedImmune in 2014). It has its research and development concentrated in three strategic centres: Cambridge, England; Gothenburg, Sweden and Gaithersburg in Maryland, US.
• Product Description: Rilvegostomig
• Rilvegostomig (AZD-2936) is a bi-specific antibody acts by targeting T cell immunoreceptor with Ig and ITIM domains (TIGIT) and programmed cell death protein 1 (PD1). It is derived from COM902 (anti-TIGIT antibody). It is administered through Intravenous route.
• Currently, the drug is in the Phase III stage of its development for the treatment of Biliary cancer. The drug is also under development for the treatment of solid tumors, advanced or metastatic squamous or non-squamous non-small cell lung carcinoma, squamous or non-squamous non-small cell lung cancer and locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, cholangiocarcinoma and gallbladder cancer.

2. Company Overview: Innovent Biologics

• Innovent Biologics is a global biopharmaceutical company established in 2011, with a focus on developing, manufacturing, and marketing innovative drugs for the treatment of cancer and other major diseases. The company has a strong emphasis on research and development, with a pipeline consisting of assets designed to address unmet medical needs in the fields of cancer and other therapeutic areas. In addition, the company operates the Innovent Academy, a research platform dedicated to new drug discovery, and has a lab in the United States focused on disease-mechanism studies.
• Product Description: IBI323
• IBI323 is a recombinant LAG-3/PD-L1 bispecific antibody. Preclinical studies showed that IBI323 effectively blocks both the PD-1/PD-L1 and LAG-3 pathways and can generate more effective and durable activation of T lymphocyte activation than the combination of anti-PD-L1 monoclonal antibody and anti-LAG monoclonal antibody. Besides, through the bridging effect of bispecific antibody, tumor cells expressing PD-L1 can be drawn closer to T lymphocyte expressing LAG-3, thus forming stable TCR: MHC immune synapses and enhancing T lymphocyte activation. Currently, the drug is in the Phase II stage of its development for the treatment of Solid tumours.

3. Company Overview: Laekna Therapeutics

• Laekna is a clinical-stage global biotechnology company, dedicated to bringing ground-breaking therapies to cancer and liver fibrosis patients worldwide.
• Product Description: FAZ053
• FAZ053 (anti-PD-L1) is an investigational immuno-oncology treatment being developed by Laekna Therapeutics for patients with advanced cancers. It is a monoclonal antibody directed against a protein called programmed cell death-1 ligand 1 (PD-L1). Upon administration, anti-PD-L1 monoclonal antibody FAZ053 binds to PD-L1, blocking its binding to and activation of its receptor programmed death 1 (PD-1), which may enhance the T-cell-mediated anti-tumor immune response and reverse T-cell inactivation. Laekna initiated a Phase I trial in combination with PDR001 in patients with advanced solid tumors. The aim of this trial is to address the unmet needs of people with cancer and bring innovative, effective treatments to more cancer patients across China.

4. Company Overview: Aurigene Discovery Technologies

• Aurigene Discovery Technologies is a biotech company based in Bengaluru and Kuala Lumpur, with a focus on developing innovative therapeutics for cancer treatment. The company offers integrated solutions to pharmaceutical companies, including discovery biology services, custom development, and manufacturing of clinical compounds and commercial contract manufacturing. Aurigene has a team of scientists in India, supported by state-of-the-art facilities in the UK, Mexico, and the United States
• Product Description: AUR-106
• AUR-106 is an oral, small molecule inhibitor of TIGIT and POLI, developed from Aurigencie emall molecule 10 platform. In contrast to antibodies, AUR-106 offers the advantages of ease of combination dosing, the ability to manage immune-related adverse events (irAEs), and lower COGs. Currently, the drug is in the Phase I stage of its development for the treatment of cancer.
• Further product details are provided in the report……..
•  
• PD-1 and PD-L1 Inhibitors Analytical Perspective by DelveInsight
• In-depth Commercial Assessment: PD-1 AND PD-L1 Inhibitors Collaboration Analysis by Companies
• The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.
• PD-1 and PD-L1 Inhibitors Competitive Landscape
• The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

PD-1 and PD-L1 Inhibitors Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

• Current Treatment Scenario and Emerging Therapies:
• How many companies are developing PD-1 and PD-L1 Inhibitors drugs?
• How many PD-1 AND PD-L1 Inhibitors drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of PD-1 and PD-L1 Inhibitors?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the PD-1 and PD-L1 Inhibitors 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 PD-1 and PD-L1 Inhibitors and their status?
• What are the key designations that have been granted to the emerging and approved drugs?
•  
• Key Players
• Merck
• Laekna Therapeutics
• Genentech
• Tracon Pharmaceuticals Inc.
• Celgene
• MedImmune
• Hangzhou Sumgen Biotech
• Lepu Biopharma
• Harbour BioMed
• Curis
• BeiGene
• Apollomics
• STCube Pharmaceuticals
• Aptevo Therapeutics
• Atridia
• Centessa Pharmaceuticals
• Orum Therapeutics
• EMD Serono
• Key Products
• Envafolimab
• Keytruda
• FAZ053
• TECENTRIQ
• Durvalumab
• SG 12473
• LP 002
• HBM 9027
• CA 170
• Tislelizumab
• Geptanolimab
• STT 01
• Adebrelimab
• APVO-711
• LB-101
• Research programme: PD-1-Cbl-b
• Bintrafusp alfa

Table of Contents

Introduction

Executive Summary

PD-1 and PD-L1 Inhibitors: Overview

• Programmed Death-1 (PD-1)
• Programmed Death Ligand-1 (PD-L1)
• MOA of PD-1 and PD-L1 inhibitors
• Significance of PD-1 and PD-L1 inhibitors

PD-1 AND PD-L1 Inhibitors -Analytical Perspective: In-depth Commercial Assessment

• PD-1 AND PD-L1 Inhibitors Collaboration Analysis by Companies

Competitive Landscape

• Comparative Assessment of Companies (by therapy, development stage, and technology)

Therapeutic Assessment

• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

PD-1 AND PD-L1 Inhibitors: Company and Product Profiles (Marketed Therapies)

Merck Sharp & Dohme LLC

• Company Overview

KEYTRUDA

• Product Description
• Research and Development Activities
• Product Developmental Activities

PD-1 AND PD-L1 Inhibitors: Company and Product Profiles (Pipeline Therapies)

Late Stage Products (Phase III)

• Comparative Analysis

BIOCAD

• Company Overview

Prolgolimab

• Product Description
• Research and Development Activities
• Product Developmental Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase II)

• Comparative Analysis

Company Name

• Company Overview

Product Name

• Product Description
• Research and Development Activities
• Product Developmental Activities

Drug profiles in the detailed report…..

Early Stage Products (Phase I)

• Comparative Analysis

Laekna Therapeutics

• Company Overview

FAZ 053

• Product Description
• Research and Development Activities
• Product Developmental Activities

Drug profiles in the detailed report…..

Preclinical and Discovery Stage Products

• Comparative Analysis

Company Name

• Company Overview

Product Name

• Product Description
• Research and Development Activities
• Product Developmental Activities

Drug profiles in the detailed report…..

Inactive Products

• Comparative Analysis

PD-1 and PD-L1 Inhibitors- Unmet needs

PD-1 and PD-L1 Inhibitors - Market drivers and barriers

Appendix