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Association details:
| Biomarker: | CD8 positive |
|---|---|
| Cancer: | Melanoma |
| Drug: | Opdivo (nivolumab) (PD1 inhibitor) + vidutolimod (CMP-001) (Immunomodulator, TLR9 agonist) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
605 Neoadjuvant vidutolimod (vidu) and nivolumab (nivo) results in MPR and immune activation in high-risk resectable melanoma (MEL): final phase II clinical trial results
Published date:
11/08/2022
Excerpt:
...ORR by BICR was 45% (all) and 47% (PP). In PP population, MPR was observed in 57% (17/30) including 47% pCR (14/30) and 10% pMR (3/30). With median follow-up of 26.5 months, median RFS was not reached (table 1). Post-treatment, MPR was associated with increased CD8+ tumor infiltrating lymphocytes (p<0.0001), and peripheral immune activation and pDC activation by multiparameter flow cytometry (p < 0.001).Neoadjuvant vidu/nivo has minimal tox and demonstrated promising activity with 47% pCR rate and 57% MPR rate. MPR was associated with improved 1-/2- year RFS (94%/88%), and 1-/2- year DMFS (94%/94%) and 2-year OS (100%).
DOI:
http://dx.doi.org/10.1136/jitc-2022-SITC2022.0605
Trial ID:
