# FAST-FNA immune cell profiling in HNSCC

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2021 · $670,725

## Abstract

Currently, the single best predictive biomarker of response to anti-PD1 monotherapy is PD-L1 expression as
assessed by immunohistochemical staining of archived or fresh tissue. Current workflows for PD-L1
assessment in tissue are labor and time consuming, are not infallible (inconclusive results in a fraction of
image guided biopsies) and are associated with morbidity and are thus rarely performed serially. Rapid on site
assessment of cellular, rather than tissue, specimens obtained through fine needle aspiration (FNA) could not
only circumvent these bottlenecks but also enable more comprehensive and serial profiling of the tumor
microenvironment to obtain the most up-to-date information of a rapidly changing microenvironment during
tumor evolution and therapy. The goal of this project is to further develop and validate the new FAST-FNA
technology for rapid biomarker discovery and validation in HNSCCs. There are two main aims. In aim 1 we will
develop and validate existing and new biomarkers in FNA samples of HNSCC patients (n=100). Specifically we
will I) develop and validate new predictive immunotherapeutic biomarkers and ii to determine how well the new
FAST-FNA scores correlate with the CPS scores of PD-L1. The goal of the second aim is to translate the
above FAST-FNA technology to serial FNA analyses in HNSCC patients receiving anti-PD1 immunotherapy
(with or without chemotherapy; n=100). FNA sampling will be performed pre- and on-treatment in order to
capture changes in the tumor microenvironment. As the HNSCC field shifts toward increased biomarker
testing, we find an unmet clinical need to develop advanced cellular diagnostics in HNSCCs, which will
facilitate rapid biomarker analysis, guide therapies and provide “real time” assessment of clinical response.

## Key facts

- **NIH application ID:** 10154199
- **Project number:** 1R01CA257623-01
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Sara Isabel Pai
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $670,725
- **Award type:** 1
- **Project period:** 2021-01-26 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10154199

## Citation

> US National Institutes of Health, RePORTER application 10154199, FAST-FNA immune cell profiling in HNSCC (1R01CA257623-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10154199. Licensed CC0.

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