Persistent, recurrent, or metastatic cervical cancer with PD-L1 CPS ≥1 by 22C3 IHC. KEYNO...

Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.

ID	`RF-CERVICAL-PDL1-CPS-1-PLUS`
Type	Red flag
Status	reviewed 2026-04-27
Diseases	`DIS-CERVICAL`
Sources	`SRC-ESMO-CERVICAL-2024` `SRC-NCCN-CERVICAL-2025`

Red Flag Origin

Definition	Persistent, recurrent, or metastatic cervical cancer with PD-L1 CPS ≥1 by 22C3 IHC. KEYNOTE-826 (Colombo NEJM 2021; final OS 2023) established pembrolizumab + chemotherapy ± bevacizumab as 1L over chemo ± bev alone for CPS ≥1 (mOS 28.6 vs 16.5 mo at CPS ≥1, HR 0.64). FDA + EMA approved pembrolizumab + paclitaxel + cisplatin or carboplatin ± bevacizumab for CPS ≥1 cervical cancer 1L. KEYNOTE-A18 (Lorusso Lancet 2024) extends pembrolizumab to high-risk locally advanced cervical cancer + chemoradiation regardless of PD-L1.
Clinical direction	intensify
Category	high-risk-biology

Trigger Logic

{
  "any_of": [
    {
      "comparator": ">=",
      "finding": "pdl1_cps",
      "threshold": 1
    },
    {
      "comparator": ">=",
      "finding": "pdl1_cps_22c3",
      "threshold": 1
    },
    {
      "comparator": ">=",
      "finding": "BIO-PDL1-CPS",
      "threshold": 1
    }
  ],
  "type": "biomarker"
}

Notes

CPS ≥1 captures ~85% of cervical cancers (vs HNSCC where the cutoff is more discriminative). Cemiplimab (EMPOWER-Cervical-1, Tewari NEJM 2022) — second-line ICI option for platinum-pretreated, also CPS- agnostic in approval but with greater benefit at higher PD-L1. Tisotumab vedotin (innovaTV-204, FDA 2021) — ADC for 2L+ R/R cervical regardless of PD-L1, mDOR ~8 mo. KEYNOTE-A18 extends ICI to LOCALLY ADVANCED disease (FIGO IIIB-IVA): pembro + cisplatin-RT (concurrent) improved PFS, regulatory approval pending in many jurisdictions. Detection: 22C3 IHC; reported as CPS, NOT TPS (cervical PD-L1 lives in tumor + immune cells, CPS captures both). Pseudoprogression and hyperprogression rates similar to other ICI tumors. Access UA: pembrolizumab NSZU-listed for cervical CPS ≥1 (2025) — major access improvement.

Used By

Red flag

RF-PAN-PDL1-CLONE-22C3-PEMBRO-ELIGIBLE - PD-L1 IHC result generated using the Dako 22C3 pharmDx clone — the FDA-approved companion...