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
6171 - Molecular EGFR/PD-L1 profile of glioblastoma: Hints for therapeutic strategies
Presenter: Wojciech Szopa
Session: Poster Display session 1
Resources:
Abstract
4418 - Role of Intraoperative MRI (iMRI) in neurosurgery, potential imaging tool for maximizing gross total resection (GTR) rate of CNS tumours.
Presenter: Shweta Wadhwa
Session: Poster Display session 1
Resources:
Abstract
4791 - Tumor related impairments of neurocognitive functions in patients with brain metastases
Presenter: Lei Wen
Session: Poster Display session 1
Resources:
Abstract
5372 - Is radiation therapy influencing Alzheimer’s in Brain and Head and Neck Cancers?
Presenter: Anas Saad
Session: Poster Display session 1
Resources:
Abstract
2329 - Mature Treatment Results of 120 Cases of Acoustic Neuroma Treated with Cyberknife at a single institution.
Presenter: Shawn Malone
Session: Poster Display session 1
Resources:
Abstract
3207 - A phase II/III trial of high-dose, intermittent sunitinib in patients with recurrent glioblastoma: the STELLAR study
Presenter: Cyrillo Brahm
Session: Poster Display session 1
Resources:
Abstract
3589 - CNS penetration and Preliminary Efficacy of Sacutizumab Govitecan in Breast Brain Metastasis and Glioblastoma: A Surgical Study
Presenter: Andrew Brenner
Session: Poster Display session 1
Resources:
Abstract
1969 - Wedge resection with omission of lymph node dissection as an optional treatment strategy in octogenarians or older with early stage non-small cell lung cancers
Presenter: Takahiro Mimae
Session: Poster Display session 1
Resources:
Abstract
5116 - Characterization of lung tumorspheres reveals cancer stem-like cells potential targets and prognostic markers in non-small cell lung cancer
Presenter: Alejandro Herreros Pomares
Session: Poster Display session 1
Resources:
Abstract
5823 - Pulmonary tumor-draining vein exosomal lincRNA-p21 levels impacts non-small cell lung cancer prognosis
Presenter: Joan Castellano
Session: Poster Display session 1
Resources:
Abstract