PD-L1
37 EU-approved indications of 11 drugs need a PD-L1 result, in 9 tumour types, most of them in non-small cell lung cancer, oesophageal cancer and head and neck squamous cell carcinoma.
Cut-offs by tumour
Each row is a tumour type and each column a scoring system. Select a cut-off to list only the approvals that use it.
Scroll horizontally to compare all scoring systems.
| Tumour | TPS | CPS | TC | IC | TAP |
|---|---|---|---|---|---|
| NSCLC | |||||
| TNBC | |||||
| Gastric/GEJ | |||||
| Oesophageal | |||||
| Ovarian | |||||
| Cervical | |||||
| Urothelial | |||||
| Melanoma | |||||
| HNSCC |
Approved indications37
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Non-small cell lung cancer12 | ||||
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 |
| Triple-negative breast cancer3 | ||||
Tecentriq | IC ≥ 1% | + nab-paclitaxel | 1L advanced | No prior chemotherapy for metastatic disease |
Keytruda | CPS ≥ 10 | + chemotherapy | 1L advanced | No prior chemotherapy for metastatic disease |
Trodelvy | CPS ≥ 10 | + pembrolizumab | 1L advanced | No prior systemic therapy for metastatic disease |
| Gastric and GEJ adenocarcinoma4 | ||||
Opdivo | CPS ≥ 5, HER2-negative | + fluoropyrimidine- and platinum-based combination chemotherapy | 1L advanced | None |
Keytruda | CPS ≥ 1, HER2-negative | + fluoropyrimidine and platinum-containing chemotherapy | 1L advanced | None |
Keytruda | CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy | 1L advanced | None |
Tevimbra | TAP score ≥ 5%, HER2-negative | + platinum and fluoropyrimidine-based chemotherapy | 1L advanced | None |
| Oesophageal cancer7 | ||||
Yervoy | Tumour cell PD-L1 expression ≥ 1% | + nivolumab | 1L advanced | Squamous cell carcinoma only |
Opdivo | Tumour cell PD-L1 expression ≥ 1% | + fluoropyrimidine- and platinum-based combination chemotherapy | 1L advanced | Squamous cell carcinoma only |
Opdivo | CPS ≥ 5, HER2-negative | + fluoropyrimidine- and platinum-based combination chemotherapy | 1L advanced | Adenocarcinoma only |
Opdivo | Tumour cell PD-L1 expression ≥ 1% | + ipilimumab | 1L advanced | Squamous cell carcinoma only |
Keytruda | CPS ≥ 10 | + platinum and fluoropyrimidine-based chemotherapy | 1L advanced | None |
Hetronifly | CPS ≥ 5 | + fluoropyrimidine- and platinum-based chemotherapy | 1L advanced | Squamous cell carcinoma only |
Tevimbra | TAP score ≥ 5% | + platinum-based chemotherapy | 1L advanced | Squamous cell carcinoma only |
| Ovarian cancer1 | ||||
Keytruda | CPS ≥ 1 | + paclitaxel, with or without bevacizumab | 2L advanced | After one or two prior systemic treatment regimens; platinum-resistant |
| Cervical cancer1 | ||||
Keytruda | CPS ≥ 1 | + chemotherapy with or without bevacizumab | Any line advanced | None |
| Urothelial carcinoma3 | ||||
Opdivo | Tumour cell PD-L1 expression ≥ 1% | Monotherapy | Adj. | Muscle-invasive only; After radical resection of MIUC; High risk of recurrence |
Tecentriq | IC ≥ 5% | Monotherapy | Any line advanced | Cisplatin-ineligible |
Keytruda | CPS ≥ 10 | Monotherapy | Any line advanced | Cisplatin-ineligible |
| Melanoma1 | ||||
Opdualag | TPS < 1% | Monotherapy | 1L advanced | Aged 12 years and older |
| Head and neck squamous cell carcinoma5 | ||||
Keytruda | CPS ≥ 1 | Monotherapy | Neoadj. locally adv. | Then adjuvant pembrolizumab + radiation therapy with or without concomitant cisplatin, followed by monotherapy after surgery |
Keytruda | CPS ≥ 1 | + radiation therapy with or without concomitant cisplatin, followed by monotherapy | Adj. locally adv. | After neoadjuvant pembrolizumab and surgical resection |
Keytruda | CPS ≥ 1 | + platinum and 5-fluorouracil (5-FU) chemotherapy | 1L advanced | None |
Keytruda | CPS ≥ 1 | Monotherapy | 1L advanced | None |
Keytruda | TPS ≥ 50% | Monotherapy | 2L advanced | Progressing on or after platinum-containing chemotherapy |
PD-L1 by tumour
Label wording37
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.
- Pembrolizumab (Keytruda)
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
- Pembrolizumab (Keytruda)
KEYTRUDA as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.
- Pembrolizumab (Keytruda)
KEYTRUDA as monotherapy is indicated for the treatment of resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumours express PD-L1 with a CPS ≥ 1.
- Pembrolizumab (Keytruda)
KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).
- Pembrolizumab (Keytruda)
KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).
- Pembrolizumab (Keytruda)
KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a ≥ 50% TPS and progressing on or after platinum-containing chemotherapy (see section 5.1).
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus in adults whose tumours express PD-L1 with a CPS ≥ 10 (see section 5.1).
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1).
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥ 1.
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 and who have received one or two prior systemic treatment regimens.
- 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).
- Nivolumab (Opdivo)
OPDIVO as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC (see section 5.1).
- Nivolumab (Opdivo)
OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.
- Nivolumab (Opdivo)
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.
- Nivolumab (Opdivo)
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.
- Nivolumab (Opdivo)
OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.
- 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).
- Serplulimab (Hetronifly)
HETRONIFLY in combination with fluoropyrimidine- and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 with a CPS ≥ 5.
- Relatlimab + nivolumab (Opdualag)
Opdualag is indicated for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 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.
- Tislelizumab (Tevimbra)
Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).
- Tislelizumab (Tevimbra)
Tevimbra, in combination with platinum-based chemotherapy, is indicated for the first-line treatment of adult patients with unresectable, locally advanced or metastatic OSCC whose tumours express PD-L1 with a TAP score ≥ 5% (see section 5.1).
- Sacituzumab govitecan (Trodelvy)
in combination with pembrolizumab, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see sections 4.2 and 5.1).
- Atezolizumab (Tecentriq)
who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).
- 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).
- Atezolizumab (Tecentriq)
Tecentriq in combination with nab-paclitaxel is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumours have PD-L1 expression ≥ 1% and who have not received prior chemotherapy for metastatic disease.
- Ipilimumab (Yervoy)
YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 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