100P - Real-world insights in precision oncology: First data of the comprehensive clinico-genomics database network AIO-BNHO-CONNECT (AIO-TF-0122) in Germany

Background

Precision oncology has transformed the landscape of cancer treatment. However, challenges remain in timely molecular profiling and treatment selection processes. Molecular Tumor Boards (MTBs) have been established to guide personalized therapy decisions based on comprehensive genomic profiling. Systematic collections of real-world data, as exemplified by the AIO-BNHO-CONNECT clinical research platform, a national, retrospective and prospective, observational, multicenter study, are of paramount importance to assess the integration of MTBs into clinical practice, the utilization of NGS-guided targeted therapies, and their effectiveness in the real-world setting.

Methods

A total of 3,000 adult patients (pts) with advanced solid tumors (excluding NSCLC, SCLC, and mesothelioma) who received a multigene panel NGS analysis are planned to be enrolled in 50 study sites in Germany. Pts will be treated according to their physician’s choice based on patients’ individual needs. Focus of the study will be on pts receiving a targeted therapy based on NGS results and, overall, to assess the current status of precision oncology in real-world clinical practice in Germany. Here, we report the results of the first interim analysis (data cut-off, 31 May 2024).

Results

From Dec 2022 until May 2024, a total of 413 pts were enrolled from 21 sites. Of these, 394 met the eligibility criteria. Predominant tumor entities were colorectal (89, 22.6%), pancreatic (82, 20.8%), and biliary tract (38, 9.6%) cancers. Median time from primary diagnosis to the first NGS analysis was 8.3 months (interquartile range, 1.4 – 26.7 months). A total of 22.3% (88) of cases were discussed at an MTB and 80.7% (71) of these received an NGS-based treatment recommendation. A targeted therapy was indicated by the NGS results in 38.6% (152) of pts. Of these, 21.7% (33) were documented to have received a targeted therapy.

Conclusions

The first interim analysis of AIO-BNHO-CONNECT highlights the importance of real-world data collection in the field of precision oncology. Continued enrolment and analyses will provide a comprehensive overview of the current situation in Germany.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

AIO-Studien-gGmbH.

Funding

Daiichi Sankyo Europe GmbH, Janssen-Cilag GmbH, Merck Sharp & Dohme LLC.

Disclosure

M. Collienne: Financial Interests, Personal, Invited Speaker: RG Gesellschaft für Information und Organisation mbH; Financial Interests, Institutional, Other, local sub investigator: AbbVie, MSD Sharp & Dohme GmbH, PharmaMar, Roche, Iovance Biotherapeutics; Financial Interests, Institutional, Invited Speaker: Servier, Roche, AstraZeneca. E. von der Heyde: Financial Interests, Personal, Invited Speaker: BMS, Novartis, AstraZeneca, Ipsen, Beigene, iOMEDICO; Financial Interests, Institutional, Research Grant: Novartis, BMS, Boehringer Ingelheim, Janssen, Ipsen, AstraZeneca. A. Reinacher-Schick: Financial Interests, Personal, Invited Speaker: Amgen, Roche, Merck Serono, Bristol Myers Squibb, MSD, MCI, AstraZeneca; Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Aurikamed, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen-Cilag, Merck Serono, MSD, Pierre Fabre, Roche, Servier; Financial Interests, Personal, Other, Travel support: Amgen, MSD, Pierre Fabre, Roche; Financial Interests, Institutional, Research Grant: Roche, Ipsen, Celgene, Amgen, Alexion Pharmaceuticals, AstraZeneca, Lilly, Servier, Rafael Pharmaceutics, Erytech Pharma, BioNTech; Non-Financial Interests, Personal, Member of Board of Directors: AIO Studien GmbH. W. Knauf: Financial Interests, Institutional, Research Grant: Amgen, Janssen, Sanofi; Non-Financial Interests, Personal, Advisory Role: Off Label Kommission des GBA. F. Griesinger: Financial Interests, Personal, Invited Speaker: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Ariad, AbbVie, Siemens, Tesaro/GSK, Amgen, Sanofi, Daiichi Sankyo, Beigene, Gilead, Merck; Financial Interests, Personal, Advisory Board: Merck, Gilead, Beigene, Sanofi, Amgen, Tesaro/GSK, Siemens, AbbVie, Ariad, Takeda, Roche, Pfizer, Novartis, MSD, Lilly, Celgene, BMS, Boehringer Ingelheim, AstraZeneca, Daiichi Sankyo; Financial Interests, Institutional, Research Grant: AstraZeneca, Boehringer Ingelheim, BMS, Celgene, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, Siemens, Amgen, GSK, Daiichi Sankyo, Gilead. C.B. Westphalen: Financial Interests, Personal, Invited Speaker: Bayer, BMS, Celgene, GSK, Roche, Servier, Sirtex, Taiho, Chugai, Amgen, Falk, MSD, Merck, Janssen, AstraZeneca; Financial Interests, Personal, Advisory Board: BMS, Celgene, Shire/Baxalta, Rafael, RedHill, Roche, Incyte; Financial Interests, Personal, Other, Travel Support: Bayer, Celgene, RedHill, Roche, Servier, Taiho, Janssen; Financial Interests, Personal, Expert Testimony: Janssen; Financial Interests, Personal and Institutional, Research Grant: Roche; Non-Financial Interests, Personal, Officer: AIO - Arbeitsgemeinschaft Internistische Onkologie (Germany); Non-Financial Interests, Personal, Advisory Role, Member of the EU Commission Mission Board for Cancer: EU Commission - DG RTD; Non-Financial Interests, Personal, Advisory Role, Member Forum Zukunftsstrategie -: German Federal Ministry of Education and Research. S. Loges: Financial Interests, Personal, Invited Speaker: BerGenBio AS, BMS, Eli Lilly, Boehringer Ingelheim, Roche Pharma, Medac GmbH, Sanofi Aventis, Novartis, AstraZeneca, Pfizer, Takeda, Amgen, Janssen, Merck, MSD, Daiichi Sankyo, Bayer; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Institutional, Invited Speaker: BerGenBio AS; Financial Interests, Institutional, Research Grant: BMS, Eli Lilly, Roche Pharma, ADC Therapeutics, Daiichi Sankyo, AstraZeneca; Non-Financial Interests, Personal, Member: DGHO, ASCO, AIO. All other authors have declared no conflicts of interest.