{"entity":{"id":"idea-bio2-neoadjuvant-biomarker-engine","kind":"idea","name":"Use pre-surgery immunotherapy windows as the field's biomarker engine","aka":[],"tldr":"Giving immunotherapy for a few weeks before surgery produces a tumour sample that shows exactly what the drug did. That is the fastest way to learn who responds.","summary":"Neoadjuvant window trials deliver paired baseline and post-treatment tissue plus a pathological response readout within weeks, and they have already produced high-quality mechanistic insight in melanoma, colorectal cancer with mismatch repair deficiency and bladder cancer. Standardising a shared window protocol across tumour types, with common tissue handling and open data release, would turn scattered studies into a systematic discovery platform.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (No one can predict who responds to immunotherapy): Haslam & Prasad (JAMA Network Open 2019)","url":"https://doi.org/10.1001/jamanetworkopen.2019.2535"}],"tags":[],"related":[],"cancers":["colorectal","melanoma","urothelial"],"sections":[],"technologies":["checkpoint-inhibitor","single-cell-spatial","rna-seq"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["major-pathological-response","pcr","neoadjuvant-adjuvant"],"trials":["niche-2","nadina","checkmate-816"],"people":["myriam-chalabi","christian-blank"],"bottlenecks":["b-immunotherapy-response","b-trial-design","b-negative-results"],"keyPapers":["paper-haslam-jama-netw-open"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"A standardised multi-tumour neoadjuvant window platform identifies and validates response biomarkers at least twice as fast as advanced-disease trials, measured by biomarkers reaching prospective validation per year.","rationale":"Pathological response is available in weeks and correlates with long-term outcome in several diseases, so causal inference is far cheaper than in metastatic trials. Neoadjuvant mismatch repair deficient studies produced near-complete response rates and detailed mechanism from small numbers of patients.","test":"Launch a shared window protocol at ten centres across three tumour types with common sample processing and mandatory rapid open data release; measure biomarkers nominated and validated per year.","maturity":"being-tested-at-scale","actor":"research","cost":"medium","horizonYears":4},"route":"/ideas/idea-bio2-neoadjuvant-biomarker-engine/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"resectable-nsclc","kind":"cancer","name":"Resectable stage I to III non-small-cell lung cancer","route":"/cancers/resectable-nsclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"rna-seq","kind":"technology","name":"RNA sequencing & expression profiling","route":"/technologies/rna-seq/"},{"id":"single-cell-spatial","kind":"technology","name":"Single-cell & spatial profiling","route":"/technologies/single-cell-spatial/"}],"term":[{"id":"major-pathological-response","kind":"term","name":"Major pathological response (MPR)","route":"/terms/major-pathological-response/"},{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"},{"id":"pcr","kind":"term","name":"Pathologic complete response (pCR)","route":"/terms/pcr/"}],"trial":[{"id":"checkmate-816","kind":"trial","name":"CheckMate 816","route":"/trials/checkmate-816/"},{"id":"nadina","kind":"trial","name":"NADINA","route":"/trials/nadina/"},{"id":"niche-2","kind":"trial","name":"NICHE-2","route":"/trials/niche-2/"}],"person":[{"id":"christian-blank","kind":"person","name":"Christian Blank","route":"/people/christian-blank/"},{"id":"myriam-chalabi","kind":"person","name":"Myriam Chalabi","route":"/people/myriam-chalabi/"}],"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"},{"id":"b-immunotherapy-response","kind":"bottleneck","name":"No one can predict who responds to immunotherapy","route":"/bottlenecks/b-immunotherapy-response/"},{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"}],"paper":[{"id":"paper-haslam-jama-netw-open","kind":"paper","name":"Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs","route":"/key-papers/paper-haslam-jama-netw-open/"}],"roadmap":[{"id":"surgery-roadmap","kind":"roadmap","name":"Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work","route":"/roadmaps/surgery-roadmap/"},{"id":"trial-modernisation-roadmap","kind":"roadmap","name":"Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on","route":"/roadmaps/trial-modernisation-roadmap/"}]}}