Changing trends in phase 1 oncology clinical trials.

The Ph1 oncology trial landscape is evolving in response to advances in understanding of cancer biology, novel drug discovery platforms, and therapeutic modalities. To uncover emerging trends in oncology drug development, we identified 7,061 solid tumour Ph1 trials (2009-2021) from clinicaltrials.gov to determine the numbers of trials commenced, therapeutic classes, combinations, tumour streams, and geographical distribution. Ph1 oncology trials increased by an average of 5.2 %/year. There was a significant relative increase in the number of immunotherapy studies and a significant relative decrease in trials containing chemotherapy. Between 2009 and 2021, multi-agent combination trials outnumbered single-agent trials and single-class trials outnumbered multimodal combination trials. The proportion conducted in the Asia-Pacific significantly increased. Multiregional trials decreased during the COVID-19 pandemic, reducing projected trial numbers in Asia-Pacific and Europe whilst increasing single-region trials in North America. Further study is required to track recovery post-pandemic, and the emergence of novel modalities (e.g. ADCs and cellular therapies).
Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Richard Kelly •No disclosures Ben Tran •Research Funding: Amgen, Astellas, AstraZeneca, Bayer, BMS, Genentech, Ipsen, Janssen, Pfizer, Movember, MSD •Honorarium: Amgen, Astellas, AstraZeneca, Bayer, BMS, Ipsen, Janssen, Merck, MSD, Pfizer, Sanofi, Tolmar •Consulting/Advisory: Amgen, Astellas, AstraZeneca, Bayer, BMS, Ipsen, IQVIA, Janssen, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Tolmar Jayesh Desai •Consulting or Advisory Role: BeiGene, Pierre Fabre, Bayer, GlaxoSmithKline, KGaA, Boehringer Ingelheim, Roche/Genentech, Daiichi Sankyo Europe GmbH, Novartis, Pfizer, Ellipses Pharma, Axelia Oncology, Amgen •Research Funding: Roche, GlaxoSmithKline, Novartis, BeiGene, Lilly, Bristol-Myers Squibb, AstraZeneca/MedImmune Christina Guo •Research Funding: US DoD, Wellcome Trust •Current employee of Genentech Inc. The work presented herein is not affiliated with her current employment.
(© 2023 The Authors.)