Abstract 1696
Background
Early drug development and phase 1 (P1) clinical trials have changed dramatically in the past decade, as targeted therapies and then immune-oncology evolved. Understanding the changing trends in P1 trials allows more targeted resource investment at the site level, but also at the industry level. We describe the changes in the P1 trial landscape in solid tumours over the past decade.
Methods
P1 trials registered on ClinicalTrials.gov to start between 1/1/2009-31/12/2018 were extracted using the parameters: cancer, ≥18 years (yr) old, active, recruiting, completed, (early) P1 and interventional. Of the 7,870 trials identified, 3,031 were excluded on the following basis: not conducted in patients with solid tumours, directed at supportive care, solely involving radiotherapy (RT), testing of a device or procedure or solely involving dietary interventions. The 4,839 eligible studies were categorized by treatment type, tumor type, start date and study location. Studies were independently reviewed by two clinicians.
Results
In the past decade, there was an average increase of 5%/yr in the number of P1 registered, reflected by substantial increases in trials investigating immune-oncology agents (IO) (average increase: 36%/year) and cell therapies (CT) (average increase: 17%/yr). P1 trials using chemotherapy (C) (average decrease: 1%/yr) or targeted therapies (T) (average decrease: 1%/yr) have plateaued. Clinical trials combining IO with T or C or RT increased by an average of 45%/yr. Most P1 studies (41%) enrolled multiple tumour types. Studies frequently involved North American (68.5%), European (29.3%) and Asia Pacific sites (34%). The inclusion of Asia Pacific sites increased most substantially (average increase: 8%/year). P1 Trials Classified by Type of Therapy (2009-2018)Table:
494P
IO1 | C1 | T1 | CT1 | Total | |
---|---|---|---|---|---|
2009-10 | 4% (30) | 39% (324) | 66% (557) | 5% (39) | 839 |
2011-12 | 12% (89) | 36% (276) | 64% (491) | 3% (25) | 767 |
2013-14 | 17% (141) | 32% (258) | 57% (467) | 6% (47) | 814 |
2015-16 | 33% (364) | 29% (320) | 48% (529) | 9% (98) | 1095 |
2017-18 | 44% (581) | 23% (305) | 40% (524) | 11% (140) | 1324 |
Includes P1 trials using a combination of treatments.
Conclusions
The conduct of P1 trials has increased markedly over the past decade, driven by growing interest in IO.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Peter MacCallum Cancer Centre.
Funding
Has not received any funding.
Disclosure
J. Desai: Research grant / Funding (institution): Genentech/Roche; Research grant / Funding (institution): GlaxoSmithKline; Research grant / Funding (institution): Novartis; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Bionomics; Research grant / Funding (institution): MedImmune; Advisory / Consultancy, Research grant / Funding (institution): BeiGene; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (institution), Advisory / Consultancy: Eisai; Advisory / Consultancy: Ignyta. B. Tran: Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Amgen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: Astella; Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony: Janssen-Cilag; Advisory / Consultancy: MSD; Advisory / Consultancy: Novartis; Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Advisory / Consultancy: Tolmar; Advisory / Consultancy: Ipsen. All other authors have declared no conflicts of interest.
Resources from the same session
4079 - Triggering anti-GBM immune response with EGFR-mediated photoimmunotherapy
Presenter: Gabriela Kramer-marek
Session: Poster Display session 1
Resources:
Abstract
4364 - Upregulation of sFRP3 circulating expression levels correlates survival outcomes in glioblastoma
Presenter: Gema Bruixola
Session: Poster Display session 1
Resources:
Abstract
2327 - Characterization and pre-clinical modeling of genetic aberrations in pediatric gliomas
Presenter: Itai Moshe
Session: Poster Display session 1
Resources:
Abstract
3154 - Preclinical Study of Novel Tetracyclic Small Molecule, CC12, for Brain Cancer
Presenter: Liyun Fann
Session: Poster Display session 1
Resources:
Abstract
5759 - CHLOROBRAIN phase IB trial: The addition of chloroquine, an autophagy inhibitor, to concurrent radiation and temozolomide for newly diagnosed glioblastoma
Presenter: Inge Compter
Session: Poster Display session 1
Resources:
Abstract
1382 - A Phase II Clinical Trial Evaluating the Efficacy and Safety of Apatinib Combined with dose-dense Temozolomide in Recurrent Glioblastoma
Presenter: Yong Wang
Session: Poster Display session 1
Resources:
Abstract
4407 - Phase 0 Trial of Ceritinib in Brain Metastases and Recurrent Glioblastoma
Presenter: Shwetal Mehta
Session: Poster Display session 1
Resources:
Abstract
1469 - Pembrolizumab (Pem) in recurrent high-grade glioma (HGG) patients with mismatch repair deficiency (MMRd): an observational study
Presenter: Mario Caccese
Session: Poster Display session 1
Resources:
Abstract
4217 - Outcome of high-grade gliomas (HGGs) treated into immunotherapeutic early-phase clinical trials (ieCTs): a single-center experience
Presenter: Matteo Simonelli
Session: Poster Display session 1
Resources:
Abstract
5107 - Tolerability of PCV in Low Grade Glioma: a Real World Experience
Presenter: Razia Aslam
Session: Poster Display session 1
Resources:
Abstract