Antibody-drug Conjugates in Oncology Pipeline Analysis 2024: EMA, PDMA, FDA Approvals, Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Companies by DelveInsight

June 07 07:14 2024
Antibody-drug Conjugates in Oncology Pipeline Analysis 2024: EMA, PDMA, FDA Approvals, Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Companies by DelveInsight
Antibody-drug Conjugates in Oncology Pipeline
DelveInsight evaluates a strong pipeline of antibody-drug conjugates in oncology clinical trials, with over 30 major pharmaceutical companies poised to enter the 7MM (seven major markets).

(Albany, USA) DelveInsight’s ‘Antibody-drug Conjugates in Oncology Competitive Landscape 2024’ report provides comprehensive global coverage of available, marketed, and pipeline antibody-drug conjugates in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space and future growth potential of the antibody-drug conjugates in oncology competitive domain.

 

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Key Takeaways from the Antibody-drug Conjugates in Oncology Pipeline Report

  • Over 30+ antibody-drug conjugates companies are evaluating 35+ antibody-drug conjugates in the oncology pipeline in various stages of development, and their anticipated acceptance in the antibody-drug conjugates market would significantly increase market revenue. 
  • Leading antibody-drug conjugates companies such as Seagen, Daiichi Sankyo, AstraZeneca, ADC Therapeutics, Abbvie, Gilead Sciences, Byondis, ImmunoGen, Merck, CytomX, Genmab, MacroGenics, and others are evaluating novel antibody-drug conjugates candidates to improve the treatment landscape.
  • Key antibody-drug conjugates in oncology pipeline in various stages of development include ENHERTU, TRODELVY, Trastuzumab duocarmazine, Telisotuzumab vedotin, Patritumab deruxtecan, ENHERTU, Ladiratuzumab vedotin, Camidanlumab tesirine, CX-2029, Pivekimab sunirine, IMGC936, Mipasetamab uzoptirine, ADCT-901, ADCT-701, ADCT-212, and others.
  • In December 2022, ADC Therapeutics announced a clinical collaboration with Gilead was announced to evaluate Pivekimab with Magrolimab in relapsed/refractory AML. 
  • Byondis completed and submitted the Biologics License Application (BLA) in May 2022 and the Marketing Authorization Application (MAA) in June 2022 to the FDA and EMA, respectively, for the same.
  • In June 2022, a Phase III clinical trial was initiated for the first-line treatment for TNBC (trial name: TROPION-Breast02).
  • In June 2022, data for Patritumab deruxtecan was presented at the ASCO 2022 from the Phase I/II clinical trial for breast cancer and the Phase I clinical trial for NSCLC.
  • In February 2022, ADC Therapeutics entered into a license agreement with Eli Lilly and Company, pursuant to which the company granted Lilly worldwide exclusive rights to research, develop, and commercialize ADCs based on the company’s novel camptothecin technology.
  • In January 2022, AbbVie announced that the US FDA granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild-type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. 

 

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Antibody-drug Conjugates in Oncology Overview

The introduction of monoclonal antibodies (mAbs) has transformed cancer treatment, yet this approach is frequently insufficient. Conversely, systemic therapy, such as chemotherapy, is usually too toxic. These characteristics result in the discovery of a new class of very potent biopharmaceutical medications known as antibody-drug conjugates (ADCs), sometimes known as “biological missiles,” which fill the gap between mAbs and chemotherapies. ADCs comprise an antibody, a cytotoxic payload, and a chemical linker. Certain proteins that are overexpressed in cancer cells, such as HER2, trop2, nectin4, EGFR, CD33, CD30, and others, are targeted by approved ADCs. Several aspects determine an ADC’s final efficacy and safety, including the choice of target antigen, antibody, cytotoxic payload, linker, and conjugation procedures.

The first-generation ADCs had a severe problem with major safety concerns since the payloads were dropped off before reaching the target tumors, resulting in toxicities. However, breakthroughs in ADC design are already paying dividends for organizations addressing difficult-to-treat malignancies. ENHERTU, a flagship medicine from Daiichi and AstraZeneca that is in high demand in HER2-positive breast and stomach malignancies, is a nice example of this scenario. Despite multiple obstacles and failures, the industry has advanced due to a better understanding of the modalities and refinement of the various components (target, payload, or linker) of ADCs in newer therapeutic candidates. As a result, ADCs have piqued the interest of clinicians. With multiple ADCs on the market, the potential of this modality is only now beginning to bear fruit.

 

Find out more about FDA antibody-drug conjugates @ Antibody-drug Conjugates Analysis

 

Antibody-drug Conjugates in Oncology Pipeline Analysis: Drug Profile

ENHERTU (trastuzumab deruxtecan): AstraZeneca/Daiichi Sankyo

ENHERTU is the lead prospective new drug in the Daiichi Sankyo Cancer Enterprise’s ADC Franchise. The US FDA granted it Breakthrough Therapy Designation (BTD) and Fast Track Designation (FTD) for HER2-positive, advanced or metastatic breast cancers, and the Japanese Ministry of Health, Labour, and Welfare (MHLW) granted it Sakigake designation for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer. ENHERTU was recently approved for the treatment of HER2-mutant metastatic NSCLC (2L) and HER2-low metastatic breast cancer (post-chemo). According to AstraZeneca’s most recent financial report, ENHERTU is the third best-selling ADC, with the strongest and fastest uptake of any licensed ADC therapy.

TRODELVY (sacituzumab govitecan-hziy): Gilead Sciences

The first and only TROP2 ADC to show a benefit in overall survival (OS) in breast cancer. TRODELVY has received full approval in the United States and Project Orbis countries for 2L+ metastatic triple-negative breast cancer, and it is also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCCN), as defined in the Clinical Practise Guidelines in Oncology (NCCN Guidelines). TRODELVY gained accelerated approval for 2L metastatic urothelial carcinoma in the United States. TRODELVY is also an important part of the company’s lung cancer strategy, which is represented by first-line and second-line Stage IV lung malignancies. However, potential competition may impact TRODELVY’s growth in the next years.

 

A snapshot of the Antibody-drug Conjugates in Oncology Pipeline Drugs mentioned in the report:

Antibody-drug Conjugates in Oncology 

Company

Phase 

Indication

Trastuzumab duocarmazine 

Byondis

Preregistration

HER2-positive breast cancer

TRODELVY 

Gilead Sciences

Phase III

Non-small cell lung cancer; Small cell lung cancer; Solid tumors

Telisotuzumab vedotin

AbbVie

Phase III

Non-small cell lung cancer

Patritumab deruxtecan

Daiichi Sankyo Company

Phase III

Non-small cell lung cancer

ENHERTU 

AstraZeneca/Daiichi Sankyo

Phase II

Adenocarcinoma; Biliary cancer; Colorectal cancer; Solid tumors; Uterine cancer

Ladiratuzumab vedotin 

Merck/Seagen

Phase II

Adenocarcinoma; Breast cancer; Head and neck cancer; Malignant melanoma; Non-small cell lung cancer; Oesophageal cancer; Prostate cancer; Small cell lung cancer

Camidanlumab tesirine 

ADC Therapeutics/Genmab

Phase II

Hematological malignancies; Hodgkin’s disease

CX-2029

CytomX/AbbVie

Phase II

Diffuse large B cell lymphoma; Gastric cancer; Head and neck cancer; Non-small cell lung cancer; Oesophageal cancer; Solid tumors

Pivekimab sunirine 

ImmunoGen

Phase I/II

Acute myeloid leukemia; Blastic plasmacytoid dendritic cell neoplasm; Hematological malignancies

IMGC936

ImmunoGen/MacroGenics

Phase I/II

Colorectal cancer; Gastric cancer; Non-small cell lung cancer; Pancreatic cancer; Solid tumors; Triple-negative breast cancer

Mipasetamab uzoptirine 

ADC Therapeutics

Phase I

Solid tumors

ADCT-901

ADC Therapeutics

Phase I

Solid tumors

ADCT-701

ADC Therapeutics

Preclinical

Solid tumors

ADCT-212

ADC Therapeutics

Preclinical

Solid tumors

 

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Scope of the Antibody-drug Conjugates in Oncology Competitive Landscape Report 

  • Coverage: 7MM [United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
  • Key Antibody-drug Conjugates in Oncology Companies: BeBetter Med, BIOCAD, CanBas Co., Ltd., Laekna Therapeutics, Genentech, Alphamab Oncology, Hangzhou Sumgen Biotech, Harbour BioMed, Aurigene Discovery Technologies, BeiGene, Apollomics, BCN Biosciences, Phio Pharmaceuticals, Atridia, Jiangsu HengRui Medicine, EMD Serono, Innovent Biologics, Agenus, Eucure Biopharma, PharmaEngine, Vernalis, Array BioPharma, Genentech, Boehringer Ingelheim, Sentinel Oncology, Sierra Oncology, IMPACT Therapeutics, Alpine Immune Sciences, Arcus Biosciences, Elpiscience Biopharmaceuticals, and others
  • Key Antibody-drug Conjugates in Oncology Pipeline: ENHERTU, TRODELVY, Trastuzumab duocarmazine, Telisotuzumab vedotin, Patritumab deruxtecan, ENHERTU, Ladiratuzumab vedotin, Camidanlumab tesirine, CX-2029, Pivekimab sunirine, IMGC936, Mipasetamab uzoptirine, ADCT-901, ADCT-701, ADCT-212, and others.

 

Discover more about antibody-drug conjugates in clinical development @ Antibody-drug Conjugates in Clinical Trials

 

Table of Contents

1. Antibody-drug Conjugates in Oncology Pipeline Report Introduction

2. Antibody-drug Conjugates in Oncology Pipeline Report Executive Summary

3. Antibody-drug Conjugates in Oncology Pipeline: Overview

4. Analytical Perspective In-depth Commercial Assessment

5. Antibody-drug Conjugates in Oncology Clinical Trial Therapeutics

6. Antibody-drug Conjugates in Oncology Pipeline: Late-Stage Products (Pre-registration)

7. Antibody-drug Conjugates in Oncology Pipeline: Late-Stage Products (Phase III)

8. Antibody-drug Conjugates in Oncology Pipeline: Mid-Stage Products (Phase II)

9. Antibody-drug Conjugates in Oncology Pipeline: Early-Stage Products (Phase I)

10. Antibody-drug Conjugates in Oncology Pipeline Therapeutic Assessment

11. Inactive Products in the Antibody-drug Conjugates in Oncology Pipeline

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Key Companies

14. Key Products in the Antibody-drug Conjugates in Oncology Pipeline

15. Unmet Needs

16. Market Drivers and Barriers

17. Future Perspectives and Conclusion

18. Analyst Views

19. Appendix

 

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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