新薬開発実績

Performance of new drug development in NCCH-Japan

[Published] 2023/4/18 [Last updated] 2023/10/20

NCC in Japan

  • National Cancer Center (NCC) is a leading cancer treatment and research center in Japan.
  • NCC has two hospitals and one Research Institute (RI).
  • NCCH (Tokyo) and NCCE (Chiba) have 570 and 460 in-patient beds, respectively (total; 1000).
  • Each hospital has similar performance according to the in-patient capacity.
  • In NCC-RI, fundamental basic research is main expertise. And also, a lot of translational researches are ongoing in collaboration with academia, pharma in Japan as well as overseas.
NCC in Japan

Our Vision & Strengths

As a One-Stop-Shop Partner for Early R&D:

  1. Early development of first/best-in-class drugs and novel therapies by participating in novel global FIH phase I trials.
  2. Integrate nationwide genomics operation from foundational basic science to translational and prevision medicine at phase I clinic.
  3. Tight link to NCCRI in order to collaborate with external stakeholders/partners involved in early phase drug development and translational research (academic centers, consortia and pharmaceutical companies).
Our Vision & Strengths

Industry Sponsored trials (ISTs) and Investigator Initiated Trials (IITs) in NCCH

Total No. of trials
  • 90% of trials are industry sponsored trials.
  • 60% of trials are global trial.
  • High priority for phase I and FIH trials
  • IIT is mainly focused on rare cancer and pediatric malignancies.

Current Phase I trial, highly diversified

Multiple type phase I trials

  • Solid tumors P-I
  • Disease specific P-I
  • Hematological malignancy P-I
  • Pediatric P-I
  • Basket P-I
  • Umbrella P-I
  • Platform P-I

Essential

  • NGS screening
  • Serial tumor biopsies

Large Scale Trial

  • Backfill cohort
  • Expansion cohort

Structure for Early Drug Development in NCCH

Structure for Early drug development in NCCH

FIH trials in NCCH

  • In 2013, early drug development for solid tumors are consolidated to Dept. Experimental Therapeutics.
  • The expertise of Dept. Experimental Therapeutics is P-I and FIH for solid tumors regardless of tumor types.
FIH trials in NCCH

Phase I trials

  • In 2019, NGS has been covered by health insurance.
  • 95% of patients, NGS profiling has been done before P-I entry.
Phase I trials

FIH trials

  • In 2021, 8 (21%) out of 38 FIH achieved global FSI.
  • 26 (68%) out of 38 FIH joined from Initial cohort.
FIH trials

Key to Achieve Global FSI and Initial Cohort Commitment

In NCCH
● Recruit performance
● High frequency (95%) of NGS screening prior to visit phase I clinic
● Rapid preparation from IRB submission to contract
　　　・Ave. 29.0 days in FY2021
Outstanding performance
in Japan-team
Abbvie, Novartis, Boehringer, Eli Lilly, etc.

Our Advantage

Close relationship with regulatory agency (PMDA)
● More than 10 investigators have experienced human exchange program.
TR available
● Research institute is within the same campus.
● A lot of human bio-samples available for collaborative research
NGS screening covered by health insurance
● No need to prescreening for each trial enrollment
Center for Cancer Genomics and Advanced Therapeutics (C-CAT)
● National genomic database is available for pharma, biotech and academia.

Serial Tumor Biopsy in FIH

Serial tumor biopsy in FIH
  • Success rates of
  • Pre-treatment biopsy: 98.6%
  • On-treatment biopsy: 94.2%

Pre-treatment Biopsy

On-treatment biopsy

On-treatment Biopsy

On-treatment biopsy

Another Commitment in Phase I and FIH

New additional development proposal

Another commitment in phase I and FIH