Abstract 3569
Background
Phase I clinical trials (Ph1) are crucial in the development of new anticancer therapies. New generation Ph1 investigating novel classes of drugs led to consistent improvements in response rates and clinical benefit in enrolled patients (pts). The aim of our study is to evaluate pts enrolled in Ph1 testing targeted therapies (TT), immunotherapy (IT), and their combinations.
Methods
Data of pts screened for enrollment in Ph1 in our institution were retrieved from clinical records. Primary objectives of the study were to determine overall response rate (ORR) and clinical benefit rate (CBR), according to RECIST 1.1 or iRECIST criteria (if applicable). Logistic regression analysis was performed to evaluate the impact of different variables on ORR and CBR.
Results
From December 2014 to November 2018, 723 pts were screened [median age 57 years (22-82)]. Primary tumor locations included breast (27.7%), biliary tract (15.5%), pancreas (8.9%), lung (6.8%), colorectal (6.5%), and ovary (4.8%). 275/723 (38.0%) pts had >2 metastatic sites; 304/723 (42.0%) received >2 lines of treatment in the metastatic setting. 481 patients (66.5%) resulted screen failure, mainly due to the absence of druggable molecular alteration(s) for biomarker- driven Ph1 (56.1%), abnormal lab results (12.7%), or poor performance status (11.4%). Conversely, the 242 (33.5%) eligible pts received IT (47.5%), TT (48.3%), or IT+TT combinations (4.2%). At time of data analysis, 209 (88.6%) patients experienced disease progression. ORR and CBR were 14.8% and 28.0%, respectively. No differences were found per age (>70y), sex or drug class. Pts with ≤2 metastatic sites had a higher CBR (OR 2.67, 95%, CI 1.39-5.10; Wald test p=.003), while pts who received ≤2 lines of treatment in the metastatic setting presented with higher ORR (OR 2.37; 95%, CI 1.03-5.44; Wald test p=.004).
Conclusions
Our results confirmed the consistent improvement in terms of CBR and ORR of the new generation Ph1 as compared to historical reported data. Better outcomes were observed in less pre-treated pts with lower burden of disease, suggesting that Ph1 should be proposed in earlier lines of therapy to derive a greater benefit. Further analyses on a larger cohort of Ph1 patients are currently ongoing.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Istituto Europeo di Oncologia.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4228 - Clinical Evaluation of Drug-Eluting Bead Transcatheter Arterial Chemoembolization(D-TACE) versus Conventional TACE in Treatment of unresectable Hepatocellular Carcinoma
Presenter: Yi Chen
Session: Poster Display session 1
Resources:
Abstract
3930 - Safety profile of tepotinib in patients with advanced solid tumors: pooled analysis of phase I and II data
Presenter: Thomas Decaens
Session: Poster Display session 1
Resources:
Abstract
5373 - Drug-drug interaction profile of tepotinib with CYP3A and P-gp substrates
Presenter: Juergen Heuer
Session: Poster Display session 1
Resources:
Abstract
5455 - Bioavailability of tepotinib: impact of omeprazole and food
Presenter: Juergen Heuer
Session: Poster Display session 1
Resources:
Abstract
2618 - Tislelizumab Exposure-Response Analyses of Efficacy and Safety in Patients with Advanced Tumors
Presenter: Chi-Yuan Wu
Session: Poster Display session 1
Resources:
Abstract
2563 - Population Pharmacokinetics of Tislelizumab in Patients with Advanced Tumors
Presenter: Chi-Yuan Wu
Session: Poster Display session 1
Resources:
Abstract
2021 - The Addition of Metformin to Systemic Anticancer Therapy
Presenter: Jung Han Kim
Session: Poster Display session 1
Resources:
Abstract
5243 - Growth modulation index (GMI) as a comparative measure of clinical activity of larotrectinib versus prior systemic treatments in adult and pediatric TRK fusion cancer patients
Presenter: Antoine Italiano
Session: Poster Display session 1
Resources:
Abstract
598 - Analysis of the overall survival and main surrogates used for FDA approvals in solid and hematological malignancies.
Presenter: Maria Kleniewska-Wieczor
Session: Poster Display session 1
Resources:
Abstract
5381 - Comparison of intratumoral docetaxel exposure in cancer patients between nanoparticle entrapped docetaxel (CPC634) and conventional docetaxel (Cd): the CriTax study
Presenter: Ruben Van Eerden
Session: Poster Display session 1
Resources:
Abstract