Table 1.
Summary of approval status, indications and supporting clinical trials for immune therapies that are approved for use in patients with NSCLC.
| Drug name | Trial supporting regulatory approval | Indication | NMPA approval | FDA approval |
|---|---|---|---|---|
| Pembrolizumab (MSD) | KEYNOTE-189 (33) | In combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations | ✔ | ✔ |
| KEYNOTE-042 (34–36) | As monotherapy for the first-line treatment of patients with locally advanced or metastatic NSCLC expressing PD-L1 (Tumor Proportion Score ≥1%), with no EGFR or ALK genomic tumor aberrations | ✔ | ✔ | |
| KEYNOTE-407 (37, 38) and KEYNOTE-407 China extension (39) | In combination with carboplatin and paclitaxel a as first-line treatment for patients with metastatic squamous NSCLC | ✔ | ✔ | |
| Atezolizumab (Roche) | IMpower110 (40, 41) | As monotherapy for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥50% of tumor cells or PD-L1 stained tumor-infiltrating immune cells covering ≥10% of the tumor area), with no EGFR or ALK genomic tumor aberrations | ✔ | ✔ |
| IMpower 150 (42, 43) | In combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations | ✖ | ✔ | |
| IMpower 130 (44, 45) | In combination with albumin-bound paclitaxel and carboplatin for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations | ✖ | ✔ | |
| Cemiplimab (Sanofi) | EMPOWER Lung 1 (46) | As monotherapy for the first-line treatment of patients with NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score ≥50%), with no EGFR, ALK or ROS1 aberrations, and disease that is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic | ✖ | ✔ |
| Nivolumab (BMS) | CheckMate-227 (47) | In combination with ipilimumab as first-line treatment for adult patients with metastatic NSCLC expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations | ✖ | ✔ |
| CheckMate-9LA (45) | In combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy for the first-line treatment of adult patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations | ✖ | ✔ | |
| Camrelizumab (HengRui) | CameL (48, 49) | In combination with pemetrexed and carboplatin as first-line treatment for patients with unresectable locally advanced or metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations | ✔ | ✖ |
| Tislelizumab (BeiGene) | RATIONALE-307 (50, 51) | In combination with carboplatin and either paclitaxel or albumin-bound paclitaxel, as a first-line treatment for patients with metastatic squamous NSCLC | ✔ | ✖ |
| RATIONALE-304 (52) | In combination with chemotherapy as a first-line treatment for patients with advanced non-squamous NSCLC | ✔ | ✖ | |
| Sintilimab (Innovent) | ORIENT-11 (53) | In combination with pemetrexed and platinum chemotherapy as first-line treatment of patients with advanced or metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations | ✔ | ✖ |
| ORIENT-12 (54) | In combination with gemcitabine and platinum-based chemotherapy for the first-line treatment of patients with unresectable advanced or recurrent squamous cell NSCLC | ✔ | ✖ |
FDA, US food and drug administration; NMPA, China National Medical Products Administration; NSCLC, non-small cell lung cancer; PD-L1, programmed death ligand-1.
a
The FDA approval included pembrolizumab in combination with carboplatin and paclitaxel or albumin-bound paclitaxel.