PD-L1 in non-small cell lung cancer
12 EU-approved indications in non-small cell lung cancer need a PD-L1 result: pembrolizumab (1st line, metastatic), pembrolizumab (2nd line, advanced), nivolumab (neoadjuvant, early), nivolumab (neoadjuvant, early), nivolumab (adjuvant, early), sugemalimab (consolidation, locally advanced), durvalumab (consolidation, locally advanced), tislelizumab (1st line, advanced), atezolizumab (adjuvant, early), atezolizumab (1st line, metastatic), cemiplimab (1st line, advanced) and cemiplimab (1st line, advanced).
Histology
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| PD-L112 | ||||
Opdivo | PD-L1 expression ≥ 1% | + platinum-based chemotherapy | Neoadj. early | High risk of recurrence |
Opdivo | PD-L1 expression ≥ 1% | + platinum-based chemotherapy | Neoadj. early | Then adjuvant monotherapy after surgery; High risk of recurrence |
Tecentriq | PD-L1 expression on ≥ 50% TC, EGFR/ALK-negative | Monotherapy | Adj. early | Following complete resection and platinum-based chemotherapy; High risk of recurrence |
Opdivo | PD-L1 expression ≥ 1% | Monotherapy | Adj. early | After neoadjuvant nivolumab + platinum-based chemotherapy and surgical resection; High risk of recurrence |
Tecentriq | PD-L1 expression ≥ 50% TC or ≥ 10% IC, EGFR/ALK-negative | Monotherapy | 1L metastatic | None |
Libtayo | TPS ≥ 1%, EGFR/ALK/ROS1-negative | + platinum-based chemotherapy | 1L advanced | Locally advanced patients must not be candidates for definitive chemoradiation |
Libtayo | TPS ≥ 50%, EGFR/ALK/ROS1-negative | Monotherapy | 1L advanced | Locally advanced patients must not be candidates for definitive chemoradiation |
Keytruda | TPS ≥ 50%, EGFR/ALK-negative | Monotherapy | 1L metastatic | None |
Tevimbra | PD-L1 expression on ≥ 50% of tumour cells, EGFR/ALK-negative | + pemetrexed and platinum-containing chemotherapy | 1L advanced | Non-squamous only; For locally advanced disease: not candidates for surgical resection or platinum-based chemoradiation |
Imfinzi | TPS ≥ 1%, tumours express PD-L1 on ≥ 1% of tumour cells | Monotherapy | Consol. locally adv. | After platinum-based chemoradiation therapy without progression |
Cejemly | PD-L1 expression ≥ 1%, EGFR/ALK/ROS1-negative | Monotherapy | Consol. locally adv. | After platinum-based chemoradiotherapy without progression |
Keytruda | TPS ≥ 1% | Monotherapy | 2L advanced | After at least one prior chemotherapy regimen; prior targeted therapy if EGFR or ALK positive |
16 approvals for NSCLC need no biomarker and apply whatever the result. All approvals for NSCLC
See also
Label wording12
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Pembrolizumab (Keytruda)
KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
- Pembrolizumab (Keytruda)
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.
- Nivolumab (Opdivo)
OPDIVO in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).
- Nivolumab (Opdivo)
OPDIVO in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).
- Nivolumab (Opdivo)
OPDIVO in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by OPDIVO as monotherapy as adjuvant treatment, is indicated for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1% (see section 5.1 for selection criteria).
- Sugemalimab (Cejemly)
Cejemly as monotherapy is indicated for the treatment of unresectable stage III NSCLC with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiotherapy.
- Durvalumab (Imfinzi)
IMFINZI as monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy (see section 5.1).
- Tislelizumab (Tevimbra)
Tevimbra, in combination with pemetrexed and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have: • locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or • metastatic NSCLC.
- Atezolizumab (Tecentriq)
Tecentriq as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells (TC) and who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1 for selection criteria).
- Atezolizumab (Tecentriq)
Tecentriq as monotherapy is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumours have a PD-L1 expression ≥ 50% TC or ≥ 10% tumour-infiltrating immune cells (IC) and who do not have EGFR-mutant or ALK-positive NSCLC (see section 5.1).
- Cemiplimab (Libtayo)
LIBTAYO as monotherapy is indicated for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations
- Cemiplimab (Libtayo)
LIBTAYO in combination with platinum-based chemotherapy is indicated for the first‐line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations