1712P - Implementation of a molecular pre-screening program (MPP) in a network of public cancer centres for phase I clinical trial (Ph1-CT) candidates: The PREICO program

Background

Next-generation sequencing (NGS) and molecular tumor boards (MTB) might optimize patient (pt) selection for Ph1-CT. Here we report the first-year results of the PREICO Program, a coordinated and histology-independent NGS MPP in a network of public cancer centres in Catalonia, Spain.

Methods

Multicentre retrospective study of adult pt with advanced solid tumors candidates for Ph1-CT but ineligible for standard practice NGS. Pt underwent a centralised in-house tumor NGS panel (Illumina TruSight Oncology 500) at 3 different Catalan Institute of Oncology (ICO) centres: Hospitalet, Badalona, Girona. Molecular results were weekly reviewed by an MTB and pt were offered treatment accordingly within Ph1-CT or Special Medication Situation (SMS) program if available. The aim of the study was to analyze clinical outcomes and MPP utility for access to molecularly targeted agents (MTA).

Results

From Feb2022 to Mar2023, 120 pt were included: NGS results were available in 112 (93.3%) pt, 5 (4.2%) pt had no quality sample and 3 (2.5%) pt died before the analysis. Median age was 62 y (34-78), 60 (53.5%) pt were female and 101 (90.2%) pt had ECOG ≤1. Most common tumor sites were central nervous system (14.3%), colorectal (CRC) (12.5%) and pancreatobiliary (9.8%). Sixty-four (57.1%) pt had received ≥2 prior lines and 57 (50.9%) pt had no alternative standard of care. On average, 13 MTA Ph1-CT were recruiting per month during study period. After NGS results, 73 (65.2%) pt were not eligible for any Ph1-CT, while 12 (10.7%) pt harbored alterations eligible for at least one MT Ph1-CT. Nine (8%) pt received MTA based on actionable alterations: 7 within Ph1-CT (3 RAS/RAFwt, 2 KRAS G12Cmut, 1 ARID1Amut, 1 METmut) and 2 within SMS program (MSI-H glioblastoma, HER2-amplified CRC). ORR and median PFS/OS for these pt were 33.3% and 2.8 (.7-5.4)/5.1 (1.9-7.9) months, respectively. According to prior therapy (≤2 vs ≥3 prior lines), 3 and 6 pt received MTA, respectively.

Conclusions

Our results suggest that implementation of a coordinated MPP within a public network of cancer centres helps to identify potentially actionable alterations and increases the chances of receiving personalised therapies in a wide range of cancer types.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

J.J. Soto Castillo: Financial Interests, Personal, Other, Speakers' Bureau: Novartis; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Pfizer, Eisai, MSD. J.C. Ruffinelli: Financial Interests, Personal, Invited Speaker: Amgen; Other, Travel and accommodation: MSD, Merck, Advanced Accelerator Applications. A. Stradella: Financial Interests, Personal, Advisory Board, Advisory about CAPITELLO 291 trial: AstraZeneca; Financial Interests, Personal, Advisory Board, Advisory on new activities for residents: Novartis; Financial Interests, Personal, Invited Speaker, Trastu-Deruxtecan clinical case meeting: Daiichi; Financial Interests, Personal, Invited Speaker, meeting on new data on cyclin inhibitors: Novartis. M. Oliva Bernal: Financial Interests, Personal, Invited Speaker: Merck, MSD, BMS; Financial Interests, Personal, Advisory Board: Merck, MSD; Financial Interests, Personal, Writing Engagement: MSD; Financial Interests, Personal, Other, Teaching activities: MSD, Merck; Financial Interests, Personal, Other, IDMC: Transgene; Financial Interests, Personal and Institutional, Funding: Roche; Financial Interests, Institutional, Local PI: ALX Oncology, MSD, ISA Therapeutics BV, Roche, Ayala Therapeutics, AbbVie, Bayer, Boehringer Ingelheim, Merck, Debiopharm, Seagen, Gilead; Financial Interests, Institutional, Funding: GSK; Non-Financial Interests, Institutional, Product Samples: Roche. M. Calvo Campos: Financial Interests, Personal, Advisory Board: Roche, Eisai; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca; Financial Interests, Personal, Other, Safety. Phase I trial: NERVIANO. M. Jové: Financial Interests, Personal, Invited Speaker, Educational: AstraZeneca, Roche; Financial Interests, Personal, Invited Speaker, Educational activity: BMS; Other, Other, Travel, accomodation and expenses: Takeda, Roche, MSD, VCN. R. Villanueva Vazquez: Financial Interests, Personal, Invited Speaker: Lilly; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Other, Congress attendance registration: Pfizer, Novartis, Eisai. M.A. Bergamino: Financial Interests, Personal, Invited Speaker: Esai; Financial Interests, Personal, Funding, Travel funding for congress: Novartis; Financial Interests, Personal, Funding, Travel funding for congresses: Esai. S. Villatoro Gómez: Financial Interests, Personal, Invited Speaker: AstraZeneca, Illumina. C. Hierro: Financial Interests, Personal, Invited Speaker: MSD, Lilly; Financial Interests, Personal, Research Grant, Principal Investigator of Merck Research Grant in Personalized Medicine 2020 : Merck; Non-Financial Interests, Principal Investigator, Clinical Trial: BMS, Zymeworks, ALX Oncology, AstraZeneca; Other, Other, Travel fees: BMS, Amgen, Roche, Merck. M. Gil Martín: Financial Interests, Personal, Invited Speaker: MSD, GSK, Clovis. C. Lazaro: Financial Interests, Personal, Advisory Board, Advisory boards on BRCA and HRD testing: AstraZeneca; Financial Interests, Personal, Advisory Board, IVDR advisory group: Illumina; Financial Interests, Institutional, Funding: AstraZeneca. J. Martin-Liberal: Financial Interests, Personal, Invited Speaker: Astellas, Bristol Myers Squibb, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Sanofi; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Novartis, Pierre Fabre, Roche, Sanofi, Highlight Therapeutics; Financial Interests, Personal, Other, Travel grant: Bristol Myers Squibb, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Ipsen. All other authors have declared no conflicts of interest.