An overview of PD-L1

scoring by tumour type

Indication

First-line treatment, as monotherapy, of adult patients with metastatic non-small cell lung carcinoma (NSCLC) or stage III disease where patients are not candidates for surgical resection or definitive chemoradiation, expressing PD-L1 [Tumour Proportion Score (TPS ≥ 1%)] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations.

Indication

Treatment of adult patients with metastatic NSCLC as monotherapy, whose tumours express PD-L1 [(Tumour Proportion Score (TPS) ≥ 1%)] as determined by a validated test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have received authorized therapy for these aberrations prior to receiving KEYTRUDA®.

Indication

First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PD-L1 expression (Combined Positive Score [CPS] ≥ 1) as determined by a validated test.

Indication

Adult patients in combination with chemotherapy with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumors express PD-L1 (Combined Positive Score [CPS] ≥ 10) as determined by a validated test.

Indication

Treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1 (CPS ≥ 1) as determined by a validated test, in combination with chemotherapy with or without bevacizumab.

Indication

In combination with trastuzumab, fluoropyrimidine- and platinum- containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours express PD-L1 (CPS ≥ 1) as determined by a validated test.

Indication

First-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Indication

Adjuvant treatment of adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy.

Indication

Treatment of adult patients with metastatic squamous NSCLC in combination with carboplatin and either paclitaxel or nab-paclitaxel, with no prior systemic chemotherapy treatment for metastatic NSCLC.

Indication

Treatment of adult patients with metastatic non-squamous NSCLC in combination with pemetrexed and platinum chemotherapy, with no EGFR or ALK genomic tumour aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC.

Indication

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma, as monotherapy, who have disease progression during or following platinum-containing chemotherapy or within 12 months of completing neoadjuvant or adjuvant platinum- containing chemotherapy.

Indication

Treatment of adult patients with unresectable or metastatic melanoma who have not received prior treatment with ipilimumab. Subjects with BRAF V600 mutant melanoma may have received prior BRAF inhibitor therapy.

Indication

Adjuvant treatment of adult patients with Stage III melanoma with lymph node involvement who have undergone complete resection.

Indication

First-line treatment of locally advanced unresectable or metastatic, carcinoma of the esophagus in combination with platinum and fluoropyrimidine based chemotherapy, in adult patients.

Indication

First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in combination with platinum and fluorouracil (FU) chemotherapy, in adult patients.

Indication

Adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection.

Indication

Treatment of adult patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor.

Indication

Treatment of adult patients with advanced (not amenable to curative surgery or radiation) or metastatic RCC in combination with lenvatinib with no prior systemic therapy for metastatic RCC.

Indication

Treatment of adult patients with advanced or metastatic renal cell carcinoma (RCC) in combination with axitinib, with no prior systemic therapy for metastatic RCC.

Indication

Adjuvant treatment, as monotherapy, of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Indication

First-line treatment, as monotherapy, of adult patients with metastatic MSI-H or dMMR colorectal cancer as determined by a validated test.

Indication

Treatment of adult patients with advanced endometrial carcinoma, in combination with lenvatinib, that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy and are not candidates for curative surgery or radiation.

Indication

Treatment of adult patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.

Indication

Adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (as determined by a validated test) whose tumours have progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as monotherapy.

Indication

Adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) endometrial cancer (as determined by a validated test) whose tumours have progressed following prior therapy and who have no satisfactory alternative treatment options, as monotherapy.

Indication

Treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC), in combination with gemcitabine-based chemotherapy.