Table 1 ICB therapies approved by FDA or NMPA for the treatment of LSCC
Drug | Brand name | Developer | Target | Approved treatment options for LSCC | Approval time | Related trial |
|---|---|---|---|---|---|---|
Nivolumab | Opdivo® | Bristol-Myers Squibb Co. | PD-1 | Neoadjuvant treatment with platinum-doublet chemotherapy for adult patients with resectable NSCLC (The first FDA approval of a checkpoint inhibitor for neoadjuvant treatment of lung cancer) | 3/4/2022 | CHECKMATE-816 (NCT02998528) |
First-line treatment plus ipilimumab and 2 cycles of platinum-doublet chemotherapy for patients with metastatic NSCLC, with no EGFR or ALK genomic tumor aberrations. (FDA) | 3/26/2020 | CHECKMATE-9LA (NCT03215706) | ||||
First-line treatment plus ipilimumab for patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations (The first and currently the only FDA approval of a checkpoint inhibitor combination for the treatment of NSCLC) | 3/15/2020 | CHECKMATE-227 (NCT02477826) | ||||
Second-line treatment for patients with metastatic squamous NSCLC whose disease progressed during or following platinum-containing chemotherapy (FDA) | 3/4/2015 | CHECKMATE-017 (NCT01642004) | ||||
Pembrolizumab | Keytruda® | Merck & Co. Inc. | PD-1 | First-line treatment for patients with stage III NSCLC who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have EGFR or ALK genomic aberrations and express PD-L1 (TPS ≥ 1%) (FDA) | 4/11/2019 | KEYNOTE-042 (NCT02220894) |
First-line treatment with carboplatin and either paclitaxel or nab-paclitaxel for metastatic squamous NSCLC (FDA) | 10/30/2018 | KEYNOTE-407 (NCT02775435) | ||||
First-line treatment for patients with metastatic NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%), with no EGFR or ALK genomic tumor aberrations, and no prior systemic chemotherapy treatment for metastatic NSCLC (The first FDA approval of a checkpoint inhibitor for first-line treatment of lung cancer) | 10/24/2016 | KEYNOTE-024 (NCT02142738) | ||||
Second-line treatment for patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥ 1%), with disease progression on or after platinum-containing chemotherapy. (FDA) | 10/24/2016 | KEYNOTE-024 (NCT02142738) | ||||
Cemiplimab | Libtayo® | Regeneron Pharmaceuticals, Inc. | PD-1 | First-line treatment for patients with advanced NSCLC (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (TPS ≥ 50%), with no EGFR, ALK or ROS1 genomic tumor aberrations (FDA) | 2/22/2021 | EMPOWER-Lung 1 (NCT03088540) |
Atezolizumab | Tecentriq® | Genentech, Inc. | PD-L1 | Adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA NSCLC whose tumors have PD-L1 expression on ≥1% of tumor cells (The first FDA approval of a checkpoint inhibitor for adjuvant treatment of lung cancer) | 10/15/2021 | IMpower010 (NCT02486718) |
First-line treatment for adult patients with metastatic NSCLC whose tumors have high PD-L1 expression (TC ≥ 50% or IC ≥ 10%), with no EGFR or ALK genomic tumor aberrations (FDA) | 5/18/2020 | IMpower110 (NCT02409342) | ||||
Second-line treatment for patients with metastatic NSCLC whose disease progressed during or following platinum-containing chemotherapy (FDA) | 10/18/2016 | OAK (NCT02008227) POPLAR (NCT01903993) | ||||
Durvalumab | Imfinzi® | AstraZeneca Inc. | PD-L1 | Treatment for patients with unresectable stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (FDA) | 2/16/2018 | PACIFIC (NCT02125461) |
Ipilimumab | Yervoy® | Bristol-Myers Squibb Co | CTLA-4 | First-line treatment plus nivolumab and 2 cycles of platinum-doublet chemotherapy for patients with metastatic NSCLC, with no EGFR or ALK genomic tumor aberrations (FDA) | 3/26/2020 | CHECKMATE-9LA (NCT03215706) |
|  |  |  |  | First-line treatment plus nivolumab for patients with metastatic NSCLC whose tumors express PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations (The first and currently the only FDA approval of a checkpoint inhibitor combination for the treatment of NSCLC) | 3/15/2020 | CHECKMATE-227 (NCT02477826) |
Sintilimab | Tyvyt® | Innovent Biologics (Suzhou) Co. Ltd. | PD-1 | First-line treatment with gemcitabine and platinum for patients with locally advanced or metastatic squamous NSCLC (NMPA) | 6/1/2021 | ORIENT-12 (NCT03629925) |
Camrelizumab | AiRuiKa® | Jiangsu Hengrui Pharmaceuticals | PD-1 | First-line treatment with carboplatin and paclitaxel for patients with locally advanced or metastatic squamous NSCLC (NMPA) | 12/10/2021 | CameL-sq (NCT03668496) |
Tislelizumab | BaiZeAn® | BeiGene | PD-1 | Second-line or third-line treatment for patients with locally advanced or metastatic NSCLC with disease progression during or following treatment with at least one platinum-containing regimen | 1/5/2022 | RATIONALE 303 (NCT03358875) |
First-line treatment with carboplatin and either paclitaxel or nab-paclitaxel for patients with locally advanced or metastatic squamous NSCLC (NMPA) | 1/14/2021 | RATIONALE 307 (NCT03594747) | ||||
Sugemalimab | Cejemly® | CStone Pharmaceuticals | PD-L1 | First-line treatment with carboplatin and paclitaxel for patients with metastatic squamous NSCLC (NMPA) | 12/21/2021 | GEMSTONE-302 (NCT03789604) |
