PUBLISHER: DelveInsight | PRODUCT CODE: 1264162
PUBLISHER: DelveInsight | PRODUCT CODE: 1264162
DelveInsight's "Antibody-drug Conjugates (ADCs) Competitive landscape, 2023" report provides comprehensive insights about 30+ companies and 35+ drugs in ADCs. It covers the therapeutics assessment by product type, stage, route of administration, dosage, and dosing frequency. The report highlights the entire competitive landscape of both marketed and pipeline products in this space.
The development of monoclonal antibodies (mAbs) has altered how cancer is treated, but this modality is often insufficient. On the other hand, systemic therapy, like chemotherapy, is usually too toxic. These factors lead to the discovery of a new class of highly potent biopharmaceutical drugs known as antibody-drug conjugate (ADCs), also referred to as "biological missiles," and fills the right spot between the mAbs and chemotherapies. An ADC comprises an antibody, cytotoxic payload, and a chemical linker. The approved ADCs target certain proteins like HER2, trop2, nectin4, EGFR, CD33, CD30, and others, which are overexpressed in cancer cells. Several factors, including the selection of target antigen, antibody, cytotoxic payload, linker, and conjugation techniques, influence the final efficacy and safety of an ADC.
The first-generation ADCs had a drawback with major safety concerns as the payloads were dropped off before they reached target tumors, leading to toxicities. But advancements in ADC design are already paying off for companies tackling tough-to-treat cancers. A good example of this scenario is ENHERTU- a premier drug by Daiichi and AstraZeneca, enjoying strong demand in HER2-positive breast and gastric cancers. Although the field has undergone numerous challenges and failures, a greater understanding of the modality and refinement of the different components (target, payload, or linker) of ADCs in newer drug candidates has propelled the space forward. As such, ADCs have captured the attention of clinicians. With several ADCs on the market, the promise of this modality has just now bore fruit.
Further details related to other marketed ADCs are provided in the report.
ADCs are complex therapeutics with unique pharmacokinetic profiles and mechanisms of action and resistance that are yet to be fully understood. Despite their vast potential to be 'magic missiles' in cancer, ADCs have presented a huge challenge to researchers, particularly around getting the formula to balance the three parts right. With the continuous efforts by researchers in these fields, it is not difficult to envisage that future ADCs will show more surprises in targeted therapy in oncology and non-oncology indications. The success of these third-generation drugs has grabbed the attention of top-notch companies in the ADCs development space. This segment of the report overlooks the pipeline and strategies adopted by various companies that are lively indulged in ADC development activities and provides deep insights into their early to late-stage products in this domain.
Owing to the growing prevalence and better overall survival rates, lung and breast cancer treatment spaces are the major target platform for ADC developers.
In 2019, the big pharma-led AstraZeneca and Daiichi Sankyo entered a global development and commercialization agreement for Daiichi Sankyo's lead ADC, ENHERTU (trastuzumab deruxtecan), for a deal worth USD 6.9 billion. ENHERTU has grabbed regulatory approval as a second-line therapy for metastatic or recurrent HER2-positive breast cancer and HER2-positive gastric or gastroesophageal junction adenocarcinoma. Daiichi and AstraZeneca plan to broaden ENHERTU's application scope to expand its market scale. Meanwhile, in 2020, a second agreement of around USD 6 billion was made for the global development and commercialization of another ADC, datopotamab deruxtecan (DS-1062). Under the terms of both agreements, AstraZeneca and Daiichi Sankyo jointly develop and commercialize the ADCs worldwide, except in Japan, where Daiichi Sankyo has exclusive rights.
ENHERTU is the lead potential new medicine in the ADC Franchise of the Daiichi Sankyo Cancer Enterprise. It has received designations like Breakthrough Therapy Designation (BTD) and Fast Track Designation (FTD) by the US FDA for HER2-positive, advanced or metastatic breast cancers and Sakigake designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer. Recently, ENHERTU was granted approval to manage HER2-mutant metastatic NSCLC (2L) and HER2-low metastatic breast cancer (post-chemo). As per AstraZeneca's latest financial report, ENHERTU is the third best-selling ADC and has the strongest and fastest uptake of all the approved ADC therapies.
In October 2020, Gilead acquired Immunomedics and created an extensive global clinical development program, including investigating TRODELVY as a monotherapy, after the collaboration between Everest Medicines and Immunomedics in 2019. Gilead aims to grow its oncology division with TRODELVY and CAR-T cell therapies to diversify its earnings.
First and only TROP2 ADC to demonstrate overall survival (OS) benefit in breast cancer. TRODELVY received full approval for 2L+ metastatic triple-negative breast cancer in the US and Project Orbis countries and 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 Practice Guidelines in Oncology (NCCN Guidelines). TRODELVY received accelerated approval for 2L metastatic urothelial cancer in the US. TRODELVY is also a key component of the company's lung cancer strategy represented in the first-line and second-line Stage IV lung cancers. However, the possible competition could impact TRODELVY's growth in the coming years.
Further details related to other ADCs are provided in the report.
The report comprises a comparative clinical assessment of products by development stage, product type, route of administration, dosage, and dosing frequency.
The list of tables is not exhaustive, will be provided in the final report.
The list of figures is not exhaustive, will be provided in the final report.