# Use pre-surgery immunotherapy windows as the field's biomarker engine

Source: https://onco.cc/ideas/idea-bio2-neoadjuvant-biomarker-engine/  
OnCo record `idea-bio2-neoadjuvant-biomarker-engine` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- Bottleneck evidence (No one can predict who responds to immunotherapy): Haslam & Prasad (JAMA Network Open 2019): https://doi.org/10.1001/jamanetworkopen.2019.2535

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Melanoma](https://onco.cc/cancers/melanoma/), [Resectable stage I to III non-small-cell lung cancer](https://onco.cc/cancers/resectable-nsclc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [RNA sequencing & expression profiling](https://onco.cc/technologies/rna-seq/), [Single-cell & spatial profiling](https://onco.cc/technologies/single-cell-spatial/)
- terms: [Major pathological response (MPR)](https://onco.cc/terms/major-pathological-response/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)
- trials: [CheckMate 816](https://onco.cc/trials/checkmate-816/), [NADINA](https://onco.cc/trials/nadina/), [NICHE-2](https://onco.cc/trials/niche-2/)
- people: [Christian Blank](https://onco.cc/people/christian-blank/), [Myriam Chalabi](https://onco.cc/people/myriam-chalabi/)
- bottlenecks: [Failures are hidden](https://onco.cc/bottlenecks/b-negative-results/), [No one can predict who responds to immunotherapy](https://onco.cc/bottlenecks/b-immunotherapy-response/), [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/)
- key papers: [Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs](https://onco.cc/key-papers/paper-haslam-jama-netw-open/)
- roadmaps: [Surgery roadmap: radical operations → less surgery → no surgery when a drug has done the work](https://onco.cc/roadmaps/surgery-roadmap/), [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

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