
Opinion|Videos|October 7, 2024
COSMOS-CRC-01: Study Design and Methodology
Author(s)Yoshiaki Nakamura, MD, PhD
Yoshiaki Nakamura, MD, PhD, discusses how the COSMOS-CRC-01 study was designed to evaluate the efficacy of ctDNA analysis for MRD detection, outlining the rationale for patient enrollment, the timing of plasma sample collection, and the implications for monitoring disease post surgery and during adjuvant chemotherapy.
Advertisement
Episodes in this series

1. Please explain the rationale, enrollment criteria, objectives, and methodology of the COSMOS-CRC-01 study.
2. What patient and/or disease factors motivated the decision to obtain the first plasma sample for ctDNA analysis at postoperative day28?
- In your experience, how soon after resection for R0 (ie, microscopically margin negative) stage II to III CRC can ctDNA sequencing be conducted and reliably detect potential MRD at the micrometastatic level?
3. Please review the timing of pre-and postadjuvant chemotherapy plasma sampling from patients who received ACT.
- In postoperative adjuvant chemotherapy, should the patient complete all cycles before submitting a plasma sample for ctDNA analysis?
- Are there circumstances when a ctDNA sample might be obtained on treatment?
Advertisement
Related to this article

Adding the mRNA-based individualized neoantigen intismeran to pembrolizumab reduced the risk of disease recurrence or death by 42% in melanoma.

Experts weigh continuous BTK inhibitors vs fixed-duration CLL therapy, highlighting TP53/17p risk, patient logistics, and subtle zanubrutinib–acalabrutinib tolerability differences.

The FDA converted the accelerated approval of pembrolizumab in TMB-high solid tumors to traditional approval, redefining TMB-high as at least 13 mut/Mb.

Following an end-of-phase 2 meeting with the FDA, Rgenta plans to start a phase 3 trial of oral RGT-61159 in adenoid cystic carcinoma in the first quarter of 2027.

The FDA granted fast track designation to SBE303, Samsung Bioepis’ investigational Nectin-4–targeting ADC, for advanced urothelial cancer following enfortumab vedotin.

The antibody-drug conjugate sofetabart mipitecan showed efficacy and safety, leading to selection of a phase 3 dose for the FRAmework-01 trial.

FDA grants orphan drug designation to onvansertib for relapsed or refractory CMML, boosting development of the PLK1 inhibitor after early signals of activity.
Advertisement
Advertisement
Trending on Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
1
FDA Alignment Reached on Phase 3 Design for RGT-61159 in ACC
2
Sofetabart Mipitecan Elicits Responses Across FRα Levels in Ovarian Cancer
3
FDA Grants Traditional Approval to Pembrolizumab in TMB-High Solid Tumors
4
FDA Grants Fast Track Status to SBE303 in Urothelial Cancer
5

