Abstract 461P
Background
Phase I trials historically involve heavily pretreated patients (pts) with no more effective therapeutic options available and generally with poor expected outcomes (objective response rate (ORR): 9% and mOS: 9.9 mo, Arkenau et. al, BJH 2008). Phase I trials evolved over the past years and are now widely considered. However, there is scare data regarding phase I cancer centers activity and outcomes of pts enrolled into modern phase I trials. Here, we sought to provide an overview of pts inclusions and outcomes into early phase trials at Gustave Roussy (GR) over the last 5 years.
Methods
This is a monocentric retrospective study, including all pts enrolled in phase I or 1/2 clinical trials at GR from 2017 to 2021. Data regarding pts demographics, tumor types, investigational treatments and survival outcomes were collected.
Results
In total, 9894 pts with advanced solid tumors or hematological malignancies were oriented towards early phase trials. 2478 pts were screened, among which 449 (18.1%) failed screening. Reasons of screen failure were medical event (44%), biological abnormalities (21%), administrative issue (9%), technical issue (9%), other (13%) or unknown (4%). 2029 pts finally received at least one treatment dose. 169 (8.33%) pts were enrolled in at least two early phase trials. Median age was 59 years old (18-91) and tumor types were gastro intestinal (25%), lung (14%), genitourinary (12%), hematological (12%) and other types (37%). There were 224 ongoing trials overall. Amongst all pts treated and evaluable for response (1953 pts), ORR was 15.9% and disease control rate (DCR) was 46.7%. mPFS and mOS were respectively of 2.7 mo (95%CI, 2.5-2.8) and 12.6 mo (95%CI, 11.9-13.7). For all patients, mOS after end of treatment (EOT) was 7.6 mo (95%CI, 7.2-8.4). EOT and death due to toxicity occurred in 74 (3.65%) and in 7 (0.34%) pts, respectively.
Conclusions
As compared to historical data, our study shows that outcomes of patients included in modern phase I oncology trials have improved and that these trials constitute nowadays a valid and safe therapeutic option. These updated data provide facts for adapting the methodology, role and place of phase I trials over the next years.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Linda MAHJOUBI.
Funding
Has not received any funding.
Disclosure
A. Hollebecque: Financial Interests, Personal, Invited Speaker: Servier, Incyte, EISAI; Financial Interests, Personal, Advisory Board: Basilea, Tahio, Relay Theraeutics, QED Therapeutics, Debiopharm; Financial Interests, Institutional, Funding: Incyte; Financial Interests, Institutional, Research Grant: AstraZeneca; Non-Financial Interests, Principal Investigator, M19-345: AbbVie; Non-Financial Interests, Principal Investigator, CO42216: Roche; Non-Financial Interests, Principal Investigator, MCLA-158: Merus; Non-Financial Interests, Principal Investigator, SGNB6A: Seatle Genetics; Non-Financial Interests, Principal Investigator, TAS-120-202: Tahio; Non-Financial Interests, Principal Investigator, Krystal-10: Mirati; Non-Financial Interests, Principal Investigator, ADP-0033: Adaptimmune; Non-Financial Interests, Principal Investigator, ACT16902: Sanofi; Non-Financial Interests, Principal Investigator, C4201002: Pfizer; Non-Financial Interests, Principal Investigator, RLY-4008: Relay Therapeutics; Non-Financial Interests, Principal Investigator, CC-90011: Celgene/BMS; Non-Financial Interests, Principal Investigator, Loxo-IDH: Loxo/Lilly; Non-Financial Interests, Principal Investigator: AstraZeneca. J. Michot: Financial Interests, Other: BMS, Roche, Pfizer. C. Baldini: Financial Interests, Institutional, Advisory Role, Consulting: Bicycle therapeutics, Rising TIDE FUndation, ITEOS; Financial Interests, Personal, Advisory Role, Honoraria: GSK, BMS, AZ; Financial Interests, Personal, Invited Speaker, Honoraria: Amgen, Sanofi, MSD; Financial Interests, Institutional, Funding: BMS. S. Champiat: Financial Interests, Personal, Other, Honoraria: AstraZeneca, Amgen, BMS, Janssen, MSD, Novartis, Roche. A. Marabelle: Financial Interests, Personal, Other, Honoraria: AstraZeneca, BMS, Merieux Nutrisciences, Oncovir; Financial Interests, Personal and Institutional, Advisory Board: Amgen, Bayer, Bioncotech, Boehringer Ingelheim, CERENIS THERAPEUTICS, Eisai, Gritstone Bio, ImCheck therapeutics; Financial Interests, Advisory Board: Innate Pharma, Lytix Biopharma, Merck Serono, Molecular Partners, MSD, NOVARTIS, Immunotherapeutics, Pfizer, Pierre Fabre, Redx Pharma, Roche, Sanofi, Servier, Sotio, Symphogen. S. Postel-Vinay: Financial Interests, Institutional, Funding: Roche; Financial Interests, Funding: ImCore, AstraZeneca. Y. Loriot: Financial Interests, Other: Janssen, MSD, Astellas, BMS, Seattle Genetics, AstraZeneca, Roche, Clovis, Incyte, Pfizer. S. Ponce: Financial Interests, Advisory Board: BMS, Merck, Roche; Financial Interests, Other: AstraZeneca, Merck, Roche. All other authors have declared no conflicts of interest.