PD-1 Non-Small Cell Lung Cancer (PD-1+ NSCLC) – Pipeline Insight, 2020

September 2020 | 75 pages | ID: P4CEDEFF4B17EN
DelveInsight

Abstracts

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DelveInsight’s, “PD-1 Non-Small Cell Lung Cancer (PD-1+ NSCLC) – Pipeline Insight, 2020,” report provides comprehensive insights about 30+ companies and 30+ pipeline drugs in PD-1 Non-Small Cell Lung Cancer 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

Non-Small Cell Lung Cancer Understanding

Non-Small Cell Lung Cancer (NSCLC): Overview

Lung cancer is a type of cancer that starts in the lungs. Cancer starts when cells in the body begin to grow out of control. About 80% to 85% of lung cancers are Non-Small Cell Lung Cancer. The main subtypes of Non-Small Cell Lung Cancer are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. These subtypes, which start from different types of lung cells are grouped together as Non-Small Cell Lung Cancer because their treatment and prognoses (outlook) are often similar.

The three main histological subtypes of Non-Small Cell Lung Cancer are:

• Adenocarcinoma: About 40% of all lung cancers are adenocarcinomas. These tumors start in mucus-producing cells that line the airways.
• Squamous cell carcinoma (SCC): About 25-30% of all lung cancers are Squamous cell carcinoma. This type of cancer develops in cells that line the airways and is usually caused by smoking.
• Large cell (undifferentiated) carcinoma: This type makes up around 10-15% of all lung cancers. It gets its name from the way that the cancer cells look when they are examined under a microscope.

Immune checkpoint inhibitors

An important part of the immune system is its ability to keep itself from attacking normal cells in the body. To do this, it uses “checkpoint” proteins on immune cells, which act like switches that need to be turned on (or off) to start an immune response. Cancer cells sometimes use these checkpoints to avoid being attacked by the immune system. Drugs that target these checkpoints (called checkpoint inhibitors) can be used to treat some people with non-small cell lung cancer (NSCLC). Immunotherapies targeted against programmed death ligand 1 (PD-L1) and its receptor (PD-1) have improved survival in a subset of patients with advanced lung cancer.

PD-L1 Expression in Lung Cancer

PD-L1 protein expression has emerged as a biomarker that predicts which patients are more likely to respond to immunotherapy. The understanding of PD-L1 as a biomarker is complicated by the history of use of different immunohistochemistry platforms with different PD-L1 antibodies, scoring systems, and positivity cut-offs for immunotherapy clinical trials with different anti-PD-L1 and anti-PD-1 drugs.

PD-L1 Expression Emerges as a Biomarker in Early Studies

A substantial unmet need is the development of biomarkers of response to immunotherapeutic agents, in order to identify, before initiation of treatment, which patients are likely to experience a response to and clinical benefit from such treatments. The approval of pembrolizumab for previously untreated metastatic Non-Small Cell Lung Cancer with PD-L1 expression greater than 50% has established the role of PD-L1 expression as a biomarker. But there remain questions about the application of PD-L1 testing and alternative biomarkers to explore.

PD-1 targeted Immunotherapy as First-Line Therapy for Advanced Non-Small-Cell Lung Cancer Patients

Cancer immunotherapies have revolutionized the treatment of non-small cell lung cancer. Yet, only a small subset of patients will benefit from PD-(L) 1 blockade. PD-L1 tumor cell expression is the only approved biomarker at present. Tumor mutational burden and other emerging biomarkers should improve patient selection. At present, there are two PD-1 inhibiting antibodies approved for NSCLC therapy: Nivolumab and Pembrolizumab.

PD-1 Non-Small Cell Lung Cancer Emerging Drugs Chapters

This segment of the PD-1 Non-Small Cell Lung Cancer 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.

PD-1 Non-Small Cell Lung Cancer Emerging Drugs

• REGN2810 (cemiplimab) plus Ipilimumab Combination Therapy (REGN2810/ipi): Regeneron Pharmaceuticals / Sanofi

REGN2810 (SAR439684) is an antibody-based cancer therapy that Regeneron Pharmaceuticals is developing in collaboration with Sanofi. REGN2810 is a monoclonal antibody, or manmade copy of a protein that immune cells generate to fight invaders. It targets a protein called programmed cell death 1, or PD-1, on the surface of immune T-cells and precursor B-cells, or pro-B cells. Precursor B-cells are immature white blood cells that develop into fully formed B-cells. PD-1 suppresses the immune system by binding to programmed death-ligand 1, or PD-L1 — another cell surface protein that several cancers overproduce. By binding with PD-1, REGN 2810 blocks the interaction between PD-1 and PD-L1, promoting T-cell growth and survival. The result is a revved-up immune system that can then attack cancer cells.

Regeneron Pharmaceuticals is conducting a randomized, phase 3, open-label study of combinations of REGN2810 (Anti-PD-1 Antibody), platinum-based doublet chemotherapy, and ipilimumab (Anti-CTLA-4 Antibody) versus pembrolizumab monotherapy in first-line treatment of patients with advanced or metastatic Non-Small Cell Lung Cancer with tumors expressing PD-L1 ?50%.

• Tislelizumab (BGB-A317) - BeiGene

Tislelizumab (BGB-A317) is a humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to Fc?R on macrophages. In pre-clinical studies, binding to Fc?R on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Further product details are provided in the report……..

PD-1 Non-Small Cell Lung Cancer: Therapeutic Assessment

This segment of the report provides insights about the different PD-1 Non-Small Cell Lung Cancer drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in PD-1 Non-Small Cell Lung Cancer

There are approx. 30+ key companies which are developing the therapies for PD-1 Non-Small Cell Lung Cancer. The companies which have their PD-1 Non-Small Cell Lung Cancer drug candidates in the advanced stage, i.e. pre-registration and phase III include, BeiGene, Regeneron Pharmaceuticals, Sanofi etc.

Phases

DelveInsight’s report covers around 30+ products under different phases of clinical development like

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

PD-1 Non-Small Cell Lung Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intramuscular
• Oral
• Intratumoral
• Intravenous
• Molecule Type

Products have been categorized under various Molecule types such as

• Gene therapies
• Bispecific antibodies
• Immunotherapies
• Monoclonal antibodies
• Small molecules
• Product Type

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

PD-1 Non-Small Cell Lung Cancer: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses PD-1 Non-Small Cell Lung Cancer 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 PD-1 Non-Small Cell Lung Cancer drugs.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence PD-1 Non-Small Cell Lung Cancer R&D. The therapies under development are focused on novel approaches to treat/improve PD-1 Non-Small Cell Lung Cancer.
• August 2020: Selpercatinib had durable efficacy, including intracranial activity, with mainly low-grade toxic effects in patients with RET fusion–positive PD-1 Non-Small Cell Lung Cancer who had previously received platinum-based chemotherapy and those who were previously untreated.
• August 2020: Novocure, MSD Team Up to Test TTFields-Keytruda Combo in Lung Cancer
• Novocure and MSD will together conduct a Phase 2 pilot study testing a combination of these two therapies (TTFields + pembrolizumab) as a first-line treatment for advanced or metastatic NSCLC that is positive for PD-L1 (a molecule expressed by tumor cells). NSCLC is the most common type of lung cancer, accounting for 80-85% of cases.

PD-1 Non-Small Cell Lung Cancer Report Insights

• PD-1 Non-Small Cell Lung Cancer Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

PD-1 Non-Small Cell Lung Cancer 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 PD-1 Non-Small Cell Lung Cancer drugs?
• How many PD-1 Non-Small Cell Lung Cancer 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 Non-Small Cell Lung Cancer?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the PD-1 Non-Small Cell Lung Cancer 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 Non-Small Cell Lung Cancer and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Novartis
• AstraZeneca
• Eli Lilly and Company
• Pfizer Inc.
• F. Hoffmann-La Roche Ltd.
• Merck
• Bristol Myers Squibb
• Sanofi
• IO Biotech
• Daiichi Sankyo, Inc.
• Regeneron Pharmaceuticals

Key Products

• REGN2810/ipi
• Canakinumab
• Selinexor
• AK105
• Tislelizumab
• SHR-1210
• Niraparib

Contents

Introduction
Executive Summary
PD-1 Non-Small Cell Lung Cancer: Overview
  Causes
  Mechanism of Action
  Signs and Symptoms
  Diagnosis
  Disease Management
Pipeline Therapeutics
  Comparative Analysis
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 Non-Small Cell Lung Cancer – DelveInsight’s Analytical Perspective
In-depth Commercial Assessment
  PD-1 Non-Small Cell Lung Cancer companies’ collaborations, Licensing, Acquisition -Deal Value Trends
PD-1 Non-Small Cell Lung Cancer Collaboration Deals
  Company-Company Collaborations (Licensing / Partnering) Analysis
  Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Pre-registration)
  Comparative Analysis
Tislelizumab: BeiGene
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Late Stage Products (Phase III)
  Comparative Analysis
REGN2810/ipi: Regeneron Pharmaceuticals / Sanofi
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
  Comparative Analysis
RG 7769: Roche
  Product Description
  Research and Development
  Product Development Activities
Early Stage Products (Phase I)
  Comparative Analysis
TQ B2450: Apollomics; Chia Tai Tianqing Pharmaceutical Group
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Pre-clinical and Discovery Stage Products
  Comparative Analysis
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
  Comparative Analysis
PD-1 Non-Small Cell Lung Cancer Key Companies
PD-1 Non-Small Cell Lung Cancer Key Products
PD-1 Non-Small Cell Lung Cancer- Unmet Needs
PD-1 Non-Small Cell Lung Cancer- Market Drivers and Barriers
PD-1 Non-Small Cell Lung Cancer- Future Perspectives and Conclusion
PD-1 Non-Small Cell Lung Cancer Analyst Views
PD-1 Non-Small Cell Lung Cancer Key Companies
Appendix

List Of Tables

LIST OF TABLES

Table 1 Total Products for PD-1 Non-Small Cell Lung Cancer
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

LIST OF FIGURES

Figure 1 Total Products for PD-1 Non-Small Cell Lung Cancer
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