Table 1.
Indications for immune checkpoint therapy
| Drug | Target | Combinations | Indication |
|---|---|---|---|
| Ipilimumab (Yervoy™) | CTLA‐4 | Monotherapy | Advanced (unresectable or metastatic) melanoma in adults, and adolescents 12 years of age and older |
| + Nivolumab |
Advanced (unresectable or metastatic) melanoma in adults. First‐line treatment of adult patients with intermediate/poor‐risk advanced renal cell carcinoma (RCC) |
||
| Nivolumab (Opdivo™) | PD‐1 | Monotherapy |
Advanced (unresectable or metastatic) melanoma in adults. Adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection |
| + Ipilimumab | Advanced (unresectable or metastatic) melanoma in adults. | ||
| Monotherapy | Treatment of advanced renal cell carcinoma after prior therapy in adults. | ||
| + Ipilimumab | First‐line treatment of adult patients with intermediate/poor‐risk advanced renal RCC | ||
| Monotherapy | Locally advanced or metastatic non‐small cell lung cancer (NSCLC) after prior chemotherapy in adults. | ||
| Adult patients with relapsed or refractory classical Hodgkin lymphoma after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin | |||
| Recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum‐based therapy | |||
| Locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum‐containing therapy | |||
| Pembrolizumab (Keytruda™) | PD‐1 | Monotherapy | Advanced (unresectable or metastatic) melanoma in adults |
| Adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resection | |||
| + Axitinib | First‐line treatment of advanced RCC in adults | ||
| Monotherapy | First‐line treatment of metastatic NSCLC in adults whose tumours express PD‐L1 with a ≥50% TPS with no EGFR or ALK positive tumour mutations. | ||
| + Pemetrexed and platinum | First‐line treatment of metastatic non‐squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations. | ||
| + Carboplatin and paclitaxel or nab‐paclitaxel | First‐line treatment of metastatic squamous NSCLC in adults | ||
| Monotherapy | Treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD‐L1 with a ≥1% TPS and who have received at least one prior chemotherapy regimen (EGFR mutant/ALK positive patients should also have received targeted therapy) | ||
| Adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed ASCT and brentuximab vedotin, or who are transplant‐ineligible and have failed brentuximab vedontin. | |||
| Locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum‐containing chemotherapy | |||
| Locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin‐containing chemotherapy and whose tumours express PD‐L1 with a CPS ≥10 | |||
| Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in adults whose tumours express PD‐L1 with a ≥ 50% TPS and progressing on or after platinum‐containing chemotherapy | |||
| Cemiplimab (Libtayo™) | PD‐1 | Monotherapy | Adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation |
| Atezolizumab (Tecentriq™) | PD‐L1 | Monotherapy |
Treatment of adult patients with locally advanced or metastatic urothelial carcinoma:
|
| + Bevacizumab, paclitaxel and carboplatin | First‐line treatment of adult patients with metastatic non‐squamous NSCLC (Excluding EGFR mutant/ALK positive patients) | ||
| Monotherapy | Adult patients with locally advanced or metastatic NSCLC after prior chemotherapy (EGFR mutant/ALK positive patients should also have received targeted therapy) | ||
| + Nab‐paclitaxel and carboplatin | First‐line treatment of adult patients with metastatic non‐squamous NSCLC who do not have EGFR mutant or ALK‐positive NSCLC | ||
| + Carboplatin and etoposide | first‐line treatment of adult patients with extensive‐stage small cell lung cancer | ||
| Durvalumab (Imfinzi™) | PD‐L1 | Monotherapy | Locally advanced, unresectable NSCLC in adults whose tumours express PD‐L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum‐based chemoradiation therapy |
| Avelumab (Bavencio™) | PD‐L1 | Monotherapy | Adults patients with metastatic Merkel cell carcinoma |
ALK, Anaplastic lymphoma kinase; CPS, Combined positive score; EGFR, Epidermal growth factor receptor; TPS, Tumour proportion score.
The table summarises the indications for which immune checkpoint inhibitory antibodies are approved for by the European Medicines Agency, either as monotherapy or as part of a combination of agents.
Unless otherwise stated, treatment continues until progression or unacceptable levels of toxicity. All data here is from the electronic medicines compendium Summary of Product characteristics, and are therefore EMA approved. All FDA indications are not listed here.