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
3305 - A phase I dose-escalation and expansion trial of intratumorally administered CV8102, alone and in combination with anti-PD-1 in patients with advanced solid tumors
Presenter: Jürgen Krauss
Session: Poster Display session 1
Resources:
Abstract
5353 - Phase 1/2 Study of 9-ING-41, a small molecule selective Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematological Malignancies or Solid Tumors
Presenter: Benedito Carneiro
Session: Poster Display session 1
Resources:
Abstract
3946 - Trial in progress: a Phase I, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumors (NCT03447314).
Presenter: Aaron Hansen
Session: Poster Display session 1
Resources:
Abstract
3449 - Radiographic Phenotyping to Identify Intracranial Disseminated Recurrence in Brain metastases Treated With Radiosurgery Using Contrast-enhanced MR Imaging
Presenter: CheYu Hsu
Session: Poster Display session 1
Resources:
Abstract
4553 - Association between TP53 mutations and efficacy of Osimertinib for brain metastasis from EGFR-mutant lung cancer
Presenter: Lijuan Chen
Session: Poster Display session 1
Resources:
Abstract
4942 - Response assessment of melanoma brain metastases treated by stereotactic radiotherapy or immunotherapy or both: a comparison of RECIST 1.1, RANO and iRANO criteria
Presenter: Emilie Le Rhun
Session: Poster Display session 1
Resources:
Abstract
3529 - Management of multiple brain metastases by Staged SRS focusing on utmost risk lesions
Presenter: shaoqun Li
Session: Poster Display session 1
Resources:
Abstract
5315 - Whole brain radiotherapy plus simultaneous in-field boost versus whole brain radiotherapy plus fractionated stereotactic radiotherapy for multiple brain metastases of non-small cell lung cancer
Presenter: Lu Li
Session: Poster Display session 1
Resources:
Abstract
1116 - 3D based texture analysis serving as potential diagnostic factor in discriminating primary central nervous system lymphoma from metastatic brain tumors: A preliminary study
Presenter: Wen Guo
Session: Poster Display session 1
Resources:
Abstract
5344 - Global trends in population-based survival for 303,169 adults diagnosed with glioblastoma in 44 countries during 2000-2014 (CONCORD-3)
Presenter: Fabio Girardi
Session: Poster Display session 1
Resources:
Abstract