622P - Evaluation of the metastatic colorectal cancer score (mCCS) in predicting outcome for patients with RAS wild type metastatic colorectal cancer (mCRC) treated with first-line (1L) panitumumab (PAN) plus FOLFIRI/FOLFOX: Updated interim results of the non-interventional study VALIDATE

Background

The modified mCCS intends to predict overall survival (OS) of mCRC patients (pts) at start of 1L therapy. Five clinical routine parameters assign pts into three prognostic risk groups from low to intermediate and high risk: tumor stage, tumor grading, lymph node ratio, primary tumor resection status and number of metastatic sites at start of 1L treatment (Marschner N, et al. Colorectal Dis. 2019). VALIDATE (NCT03043950) prospectively validates the mCCS in a large patient cohort with RAS WT mCRC.

Methods

VALIDATE is a multicenter, non-interventional study evaluating real-world effectiveness, safety and quality of life in pts with RAS WT mCRC receiving 1L PAN plus FOLFIRI/FOLFOX. Pts were allocated to three mCCS risk groups. This second interim analysis (IA2) was performed 24 months after last patient in. Data were analyzed descriptively for effectiveness, response rates and secondary resection rates.

Results

At data-base cut (Nov 17, 2022), 611 pts from 108 German and 5 Austrian sites were evaluable. Median age was 66.1 years, 68.9% of pts were male and 83.3% had an ECOG performance status 0/1. 59.4% of pts were diagnosed with a colon tumor. 84.3% of these pts had a left-sided tumor.

Table: 622P

Most common grade 3/4 (MedDRA v20.0) treatment-emergent adverse drug reactions (TEADR) were dermatitis acneiform (5.8%), rash (2.9%) and diarrhea (3.2%). One investigator assessed fatal TEADR (arterial embolism) occurred.

Conclusions

The IA2 showed favorable effectiveness for PAN plus FOLFIRI/FOLFOX in the total population and in all mCCS risk groups in clinical routine in Germany and Austria. Interestingly, rates of secondary resections were >20% for low and intermediate risk pts. mCCS predicting OS will be validated in the final analysis. No new safety signals emerged.

Clinical trial identification

NCT03043950.

Editorial acknowledgement

Legal entity responsible for the study

iOMEDICO AG.

Funding

Amgen.

Disclosure

M. Reiser: Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. J. Uhlig: Financial Interests, Personal and Institutional, Advisory Board: Roche, Amgen, Servier, MSD, Bristol Myers Squibb, Sanofi, Merck, Celgene, Novartis, Janssen-Cilag, Boehringer Ingelheim, Bayer, BeiGene; Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. L. Jacobasch, L. Mueller: Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. A. Schuch, L. Serrer, R. de Buhr: Financial Interests, Personal, Full or part-time Employment: iOMEDICO. H.U. Siebenbach: Financial Interests, Personal, Full or part-time Employment: iOMEDICO. T. Göhler: Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. J.K. Schröder: Financial Interests, Personal and Institutional, Advisory Board: Celgene, Roche, Bristol Myers Squibb, Clovis Oncology, GSK, Boehringer Ingelheim, Amgen, Novartis, MSD, AOP, Searchlight, Pharma Partner, Medicline, Eisai, HE Research, Octapharma, AbbVie, NIO, I+E Pharma, ISPEN, BeiGene, Milteny; Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. D. Semsek: Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. A. Koehler: Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE; Financial Interests, Personal, Advisory Board: Roche, Novartis, Pfizer, Amge, Daiichi Sankyo MSD. P. Stübs: Non-Financial Interests, Institutional, Principal Investigator: iOMEDICO/VALIDATE. K.M. Potthoff: Financial Interests, Personal, Full or part-time Employment: iOMEDICO. N.W. Marschner: Non-Financial Interests, Personal and Institutional, Invited Speaker: Amgen, BeiGene, Roche, GSK, Euspharm, stemline, Seagen, Servier; Non-Financial Interests, Personal and Institutional, Advisory Board: Amgen, AstraZeneca, BeiGene, , Bristol Myers Squibb, Celgene, Daiichi Sankyo, Deciphera, Eisai, Eusapharm, Gilead, GSK, Janssen, Lilly, Mundipharma, Merck, Mylan, MSD, Novartis, Oncopeptides, Oncovis, Pfizer, Pierre Fabre, Roche, Seagen, Servier Stemline; Financial Interests, Personal and Institutional, Member of Board of Directors: iOMEDICO; Financial Interests, Personal and Institutional, Full or part-time Employment: iOMEDICO; Financial Interests, Institutional, Ownership Interest: iOMEDICO; Non-Financial Interests, Institutional, Research Grant: Amgen, AstraZeneca, BeiGene, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Deciphera, Eisai, Eusapharm, Gilead, GSK, Janssen, Lilly, Mundipharma, Merck, Mylan, MSD, Novartis, Oncopeptides, Oncovis, Pfizer, Pierre Fabre, Roche, Seagen, Servier, Stemline; Non-Financial Interests, Institutional, Funding: Amgen, AstraZeneca, BeiGene, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Deciphera, Eisai, Eusapharm, Gilead, GSK, Janssen, Lilly, Mundipharma, Merck, Mylan, MSD, Novartis, Oncopeptides, Oncovis, Pfizer, Pierre Fabre, Roche, Seagen, Servier, Stemline; Financial Interests, Personal, Project Lead: iOMEDICO/VALIDATE.