ASCO 2025 daily highlights: Monday 2nd June
Revolutionizing Cancer Treatment: The Latest Breakthroughs in Antibody Drug Conjugates at ASCO
Results of Safety and efficacy of ABBV-706, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms.
(Abstract 105)
SEZ6 is a marker found in small cell lung cancer (SCLC) and high-grade neuroendocrine neoplasms (NENs). There is a need for new targeted therapies for NENs. ABBV-706 is an antibody-drug conjugate targeting SEZ6, being tested in a phase 1 study for patients with advanced solid tumors. Early results showed it is safe and effective in SCLC and NENs.
ABBV-706 showed promising efficacy in high-grade NENs, supporting further development in specific subtypes.
Results of Phase 1 study of SHR-1826, a c-MET–directed antibody-drug-conjugate (ADC), in advanced solid tumors.
(Abstract 106)
MET alterations are significant drivers of cancer processes, including tumor invasion, growth, and metastasis, leading to poor prognosis. SHR-1826 is an antibody-drug conjugate (ADC) targeting c-MET, attached to a potent topoisomerase I inhibitor. This first-in-human phase 1 trial evaluates SHR-1826 in patients with advanced solid tumors.
SHR-1826 demonstrated a manageable safety profile and promising anti-cancer activity in patients with heavily pretreated advanced solid tumors, particularly MET-altered NSCLC. These results warrant further investigation in this population.
Results of Phase 1 trial of SHR-A2102, a nectin-4–directed antibody drug conjugate (ADC), in advanced solid tumors.
(Abstract 107)
Nectin-4 is a cell adhesion molecule that is highly expressed in a wide variety of cancers and is associated with poor prognosis. SHR-A2102 is a novel ADC consisting of a fully humanized Nectin-4–directed monoclonal antibody, bound to topoisomerase I inhibitor payload via a cleavable linker. SHR-A2102 demonstrated a manageable safety profile and promising activity across a variety of pretreated advanced solid tumors. Multiple trials are ongoing to further assess SHR-A2102 both as monotherapy and in combination therapy for solid tumors.
Transformative power in Gynecologic Oncology: The Power of Antibody Drug Conjugates
Antibody Drug Conjugates (ADCs) are transforming the landscape of gynecologic oncology. With innovative targets like HER2, TROP2, FRα, TF, Nectin-4, B7H3, and B7H4, and various payloads, ADCs are delivering unprecedented objective response rates. From the FDA-approved Mirvetuximab soravtansine for ovarian cancer and Trastuzumab deruxtecan for pan-cancer, these therapies are paving the way for more personalized and effective treatments. Stay ahead in the fight against gynecologic cancers with the latest advancements in ADC technology.
Strategic Next Steps for ADC
- Integration of Advanced Testing Technologies
Leverage existing technologies such as immunohistochemistry (IHC) and next-generation sequencing (NGS) to test for new biomarkers like c-MET, SEZ6, and Nectin-4. These technologies are already well-established in clinical laboratories and can be adapted for new biomarkers. - Material Availability
Take into consideration the amount of material available in target diseases to allow biomarker testing. In highly competitive disease spaces such as NSCLC consider NGS testing which allows analysis of multiple targets at once. - Diagnostic Partner Selection:
Collaborate with diagnostic companies that have expertise in biomarker testing and can provide comprehensive solutions, including assay development, validation, and regulatory support. This partnership will facilitate the rapid adoption of new biomarkers in clinical practice. - Laboratory Impact Assessment
Consider the impact of introducing new biomarker tests on testing laboratories including availability of technology, expertise in biomarker testing/analysis, education requirements, workload, burden of assay verification. - Regulatory and Reimbursement Consideration
Engage with regulatory bodies to ensure that new biomarker tests meet the necessary standards for approval. Work with payers to secure reimbursement for these tests, making them accessible to a broader patient population. - Ongoing Research and Development
Continue research to further understand the role of these biomarkers in cancer progression and treatment response. Invest in clinical trials to generate robust data supporting the efficacy and safety of targeted therapies based on these biomarkers.
By following these strategic steps, the pharmaceutical industry can effectively introduce new biomarkers in cancer, enhancing personalized treatment approaches and improving patient outcomes.
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