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Table 5 FDA-approved immunotherapy in advanced/metastatic NSCLC

From: Emerging therapeutic agents for advanced non-small cell lung cancer

Drug

Class

Month/year

Indication(s)

Nivolumab (OPDIVO)

Anti-PD-1

March/2015

Metastatic squamous NSCLC with progression on or after platinum-based chemotherapy.

October/2015

Metastatic NSCLC in patients with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

Pembrolizumab (KEYTRUDA)

Anti-PD1

October/2015

Metastatic NSCLC whose tumors express PD-L1 (TPS ≥ 1%) with progression or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

October/2016

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.

May/2017

In combination with pemetrexed and carboplatin, as first-line treatment of patients with metastatic non-squamous NSCLC and with no EGFR or ALK genomic tumor aberrations.

October/2018

In combination with carboplatin and either paclitaxel or nabpaclitaxel, as first-line treatment of patients with metastatic squamous NSCLC.

April/2019

Single agent for the first-line treatment of patients with stage III NSCLC, who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 [tumor proportion score (TPS) ≥ 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

Atezolizumab (TECENTRIQ)

Anti-PD-L1

October/2016

Metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ.

December/2018

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.

December/2019

In combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

  1. TPS tumor proportion score