Abstract 76P
Background
Biomarker-driven treatment decision-making has entered routine clinical practice, particularly for patients with advanced malignancies when no further standard therapies are available. INFINITY aims to systematically analyze this approach in routine clinical care.
Methods
INFINITY is a retrospective, observational study conducted at 100 sites in Germany (medical offices and hospitals). 500 patients with advanced solid tumors or hematological malignancies who received a non-standard targeted therapy (NSTT) based on a potentially actionable biomarker will be included. Details on patient and disease characteristics, treatment, outcome, physician’s decision-making, and molecular testing will be collected. We herein present results from the second interim analysis.
Results
From 30-April-2020 to 30-June-2021, 333 eligible patients from 61 sites were registered. Most patients were treated by office-based (hematologist-)oncologists (n=237, 71.2%). Median time from primary diagnosis to start of first NSTT was 22.5 months. The majority (n=216, 64.9%) had received ≥2 prior therapy lines. Most frequent cancer entities were colorectal (n=66, 19.8%), esophageal (n=22, 6.6%), breast and gastric cancer (n=20, 6.0% each). Most frequently applied NSTT substance classes were PD-(L)1 antibodies (n=157, 47.1%) and BRAF inhibitors (n=35, 10.5%). Accordingly, most frequent actionable biomarkers were PD-L1 status, microsatellite instable (MSI) status and BRAF gene alterations. For 212 pts, information to calculate the progression-free survival (PFS) ratio was available. A PFS ratio ≥1.3 was achieved in 27.8% (59/212) of patients in the total population, 24.7% (24/97) of patients with PD-(L)1 antibody therapy, and 24.1% (7/29) with BRAF inhibitor therapy. Median overall survival was 10.9 months in the total population, 11.5 months for patients with PD-(L)1 antibody therapy, and 8.1 months for patients with BRAF inhibitor therapy.
Conclusions
Most common biomarkers driving targeted therapies included PD-L1 expression, MSI status and BRAF gene alterations. Preliminary results suggest some potential benefit in approximately one quarter of patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
iOMEDICO.
Funding
Roche, Bristol Myers Squibb.
Disclosure
U.M. Martens: Financial Interests, Personal, Advisory Role: Roche, BMS, Pierre Fabre. T. Decker: Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Role: iOMEDICO. A. Schneeweiss: Financial Interests, Institutional, Research Grant: Celgene, Roche, AbbVie; Financial Interests, Personal, Other, Travel expenses: Celgene, Roche, Pfizer; Financial Interests, Personal, Other, Honoraria: Roche, Celgene, Pfizer, AstraZeneca, Novartis, MSD, Tesaro, Lilly, Seagen, Gilead, GSK, Bayer, Amgen, Pierre Fabre. M. Schuler: Financial Interests, Personal, Advisory Role: Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Merck Serono, Novartis, Roche, Sanofi, Takeda; Financial Interests, Personal, Other, honoraria for CME presentations: Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Novartis; Financial Interests, Institutional, Funding: AstraZeneca, Bristol Myers Squibb. N.W. Marschner: Financial Interests, Personal, Other, CEO: iOMEDICO; Financial Interests, Personal, Stocks/Shares: iOMEDICO; Financial Interests, Institutional, Funding: Roche, BMS. B. Kasenda: Financial Interests, Personal, Advisory Role: Astellas, Roche; Financial Interests, Personal, Stocks/Shares: BioNTech. All other authors have declared no conflicts of interest.