대한종양내과학회

Introduction to the KOSMOS Ⅱ Study

• With the advent of diagnostic methods such as Next-Generation Sequencing (NGS) and the development of targeted therapies and novel immunotherapies, we have entered the era of 'precision medicine', which allows the diagnosis of individual cancer genetic alterations and the implementation of customized treatments.
• Although NGS diagnostic methods have been covered by insurance in Korea since 2017, the reality is that precision medicine is yet to be fully implemented, as there are still many instances where the discovered cancer gene abnormalities cannot be treated with existing drugs, or the developed drugs are not approved or covered by insurance.
• The Korean Society of Medical Oncology and the Korean Cancer Study Group established the 'Korean Precision Medicine Networking Group' and planned and conducted the KOSMOS study to expedite the implementation of precision medicine in the field of cancer treatment in Korea.
• In the KOSMOS study, cancer specialists, including oncologists, pathologists, and bioinformaticians, gathered to analyze patients' NGS test results and clinical data at the Molecular Tumor Board (MTB), and recommend the optimal treatment approach for each patient. Patients receive precision medicine customized treatment using cancer therapeutics, participate in appropriate clinical trials based on the recommendations of the MTB, or receive treatment with clinical trial drugs supplied with the support of pharmaceutical companies through KOSMOS. The KOSMOS study aggregated NGS results and clinical trial data, and treatment outcomes to build a public database, which can be used for cancer diagnosis and treatment research.
• This study is a national project being conducted with the support of the National Cancer Center's Cancer Control Project, involving the participation of government, academia, medical institutions, and industry, as well as organizations such as the Korea Health Industry Development Institute, the National Cancer Center's National Cancer Data Center, domestic and foreign biopharma companies, and genome testing firms.
• • The objectives to be achieved through the KOSMOS study are as follows :
  • Offer 1,000 patients with solid tumors the opportunity to participate in clinical trials where specialists composed of clinical and genomic experts will deliberate on precision medicine-customized treatment for cancer patients at the Molecular Tumor Board (MTB)
  • Collect real world data on clinical disease progression according to genomic alterations and build a public clinical genomic database
  • Educate clinical practitioners on the interpretation of NGS tests, application of customized treatment, and the real world application of precision medicine
  • Build a precision medicine platform that can evaluate the effectiveness and safety of precision medicine drug use and develop new cancer diagnoses and treatments
  • Conduct precision medicine clinical trials
  • Establish a Korean-style precision medicine ecosystem based on the outcomes of the KOSMOS study

Applications and Anticipated Effects of the KOSMOS II Study

• MTB (Molecular Tumor Board)

  • Cultivation of specialized personnel
  • Establishment of expertise as a decision-making body for genome-based precision treatment
• Construction of an Integrated Database

  • Collection of high-quality genomic-clinical data
  • Promotion of new drug development based on the genomic data of Korean cancer patients
  • Development of cancer clinical trials by merging AI-based methods with cancer genomic analysis results
• Provision of Precision Therapeutics

  • Expansion of drug treatment opportunities based on genomic data
  • Increase and inducement of participation in precision medicine-based clinical trials
  • Enhanced access to new drugs for patients with rare cancer genes
• Policy Proposal

  • Cultivation and training of specialized personnel
  • Establishment of expertise as a decision-making body for genome-based precision treatment

Participation Eligibility

Who Can Participate in the KOSMOS II Study?

KOSMOS II Major Eligibility Criteria

• Age 19 and above
• Locally advanced or metastatic solid cancer with disease progression after at least one standard anti-cancer therapy, or no available standard therapy
• Genomic test results must be quality-controlled in a laboratory certified by the Ministry of Food and Drug Safety or an equivalent institution.
• Patients whose care team includes a clinician practitioner/researcher who can understand and sign the written informed consent document
• Expected lifespan of at least 12 weeks
• Adequate recovery from the most recent systemic or local treatment for cancer

KOSMOS II Study Progression Process

• 

  1. Institutional NGS Testing

  Conduct NGS genomic analysis to confirm genomic alterations

• 

  2. Acquisition of Consent

  Prepare the KOSMOS II consent form for the study process

• 

  3. MTB Submission

  Submit the NGS genomic analysis results and clinical data to the MTB

• 

  4. MTB Meeting

  Discuss customized treatment or clinical trials based on the genomic analysis results and clinical data

• 

  5. Final Treatment Decision

  : Decide on the final treatment after referring to the MTB meeting decision

• 

  6. Treatment Start

  Start the customized precision treatment or clinical trial

• Patients who experienced disease progression after minimum first-line standard anticancer therapy, and/or those with advanced or metastatic solid tumor cancers for which no other standard treatments are available, who underwent next-generation sequencing gene panel testing during the course of their treatment
• Explanation on study and consent form preparation
• Input of clinical data, pathology data from tissue biopsy, genomics data, and submission to the molecular tumor board solution (NAVIFY tumor board), record of treatment method chosen by the treating physician
• The Molecular Tumor Board (consisting of cancer specialists, pathologists, bioinformatics specialists, etc.) deliberates and provides the optimal treatment recommendations for the patient
• The head of the care team selects the treatment method in accordance with the details of the Molecular Tumor Board deliberation

• Step 1

  • Use of investigational drugs for clinical trial purposes

  Step 2

  • Palliative care, radiation therapy, chemotherapy, and other treatments

  Step 3

  • Participate in clinical trials

Study Details

Participating Institutions in KOSMOS Ⅱ

Request from	Number of institutions	Target number of patients	Sign up period	Study period	Activation Site
Professor JI-hyun Kim, Seoul National University Bundang Hospital	31	1000patients	Sept. 2022-Sept. 2024	Sept. 2022-March 2026	ALL (31 institutions)

Site No.	Institution
S001	Seoul National University Bundang Hospital
S002	Seoul National University Hospital
S003	Korea University Anam Hospital
S004	Samsung Seoul Hospital
S005	Chungnam National University Hospital
S006	Asan Medical Center, Seoul
S007	Kyungpook National University Hospital
S008	National Cancer Center
S009	Kangbuk Samsung Hospital
S010	Severance Hospital
S011	Ajou University Hospital
S012	St. Mary's Hospital, Seoul
S013	Chung-Ang University Hospital
S014	Soonchunhyang University Bucheon Hospital
S015	Pusan National University Yangsan Hospital

Site No.	Institution
S016	Korea University Guro Hospital
S017	Keimyung University Dongsan Hospital
S018	Kyungpook National University Chilgok Hospital
S019	Chungbuk National University Hospital
S020	St. Vincent's Hospital
S021	Incheon St. Mary's Hospital
S022	Yeungnam University Hospital
S023	Gachon University Gil Hospital
S024	Dong-A University Hospital
S025	Bundang Cha Hospital
S026	Yeouido St. Mary's Hospital
S027	Ulsan University Hospital
S028	Wonju Severance Christian Hospital
S029	Chonbuk National University Hospital
S030	Hanyang University Hospital
S031	Hwasun Chonnam National University Hospital

Study Outcomes

(KOSMOS): KCSG AL-20-05 - ESMO Open

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Contact us

• If you have any questions about the KOSMOS II research, please send them to the email below.
• Where you want to send it : publicpolicy@ksmo.or.kr

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