Lung Cancer

On May 28, 2021, the FDA accelerated the approval of sotorasib (Lumakras; Amgen), an oral KRAS inhibitor of the RAS GTPase family, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) associated with KRAS G12C mutation, as determined by an FDA-approved test, after ≥1 systemic therapies. The FDA granted sotorasib orphan drug and breakthrough therapy designations.

On May 21, 2021, the FDA accelerated the approval of amivantamab-vmjw (Rybrevant; Janssen/Johnson & Johnson), a bispecific antibody targeting mutations in the EGFR and MET pathways, for adults with non–small-cell lung cancer (NSCLC) that is associated with EGFR exon 20 insertion mutations, as detected by the FDA-approved Guardant360 CDx test, which was approved on the same day as a companion diagnostic for amivantamab. The FDA had granted amivantamab a breakthrough therapy designation for this indication.

The COVID-19 pandemic has had a profound impact on healthcare, especially in the management of patients with cancer, who are often not seeking healthcare in the same way as before the pandemic. At the 2021 International Association for the Study of Lung Cancer (IASLC) meeting, experts discussed the implications for patients with lung cancer, specifically.

Approximately 13% of patients with lung adenocarcinomas harbor KRAS p.G12C mutations. In the phase 2 CodeBreaK 100 clinical trial, the responses to sotorasib in patients with advanced non–small-cell lung cancer (NSCLC) and KRAS p.G12C mutation were early, deep, and durable, according to Bob T. Li, MD, PhD, MPH, Medical Oncologist, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY. He presented the study results at the 2021 International Association for the Study of Lung Cancer meeting.

Sexual orientation and assigned sex at birth are significant determinants in the utilization of lung cancer screening, according to an analysis from the Behavioral Risk Factor Surveillance System (BRFSS) 2018, a cross-sectional, nationally representative database, that looked at screening among lesbian, gay, bisexual, transgender (LGBT) populations.

Genomic analysis of lung cancer in women who have never smoked may reveal novel mutations and structural alterations. Such an analysis, said Sitapriya Moorthi, PhD, Human Biology, Fred Hutchinson Cancer Research Center, Seattle, WA, may suggest unique opportunities for future target identification and therapeutic intervention. Dr Moorthi discussed the results of a mutational analysis of the Women’s Health Initiative Cohort that were presented at the 2021 International Association for the Study of Lung Cancer meeting.

On February 3, 2021, the FDA accelerated the approval of oral tepotinib (Tepmetko; EMD Serono) for adults with metastatic non–small-cell lung cancer (NSCLC) harboring MET exon 14 (METex14) skipping alterations. This approval is for treatment-naïve patients as well as for patients who have received previous therapy. Tepotinib is the second MET inhibitor approved by the FDA and should be selected for treatment based on the presence of METex14. The FDA has granted tepotinib breakthrough therapy and orphan drug designations.

On December 18, 2020, the FDA approved osimertinib (Tagrisso; AstraZeneca) for adjuvant therapy after tumor resection in patients with non–small-cell lung cancer (NSCLC) and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The FDA approved this application 2 months ahead of the FDA goal date and granted it a breakthrough therapy designation. Osimertinib was previously approved for the first-line treatment of metastatic NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations, and for the treatment of metastatic NSCLC and EGFR T790M mutation after EGFR tyrosine kinase inhibitor therapy.

Lorlatinib (Lorbrena) significantly improved progression-free survival (PFS) and intracranial response rates compared with the former standard of care, crizotinib (Xalkori), as first-line treatment for patients with advanced ALK-positive non–small-cell lung cancer (NSCLC), as reported in a planned interim analysis of the CROWN trial.

First-line treatment with the high-affinity, highly potent PD-1 inhibitor cemiplimab-rwlc (Libtayo) significantly improved overall survival (OS) and progression-free survival (PFS) compared with standard platinum-based chemotherapy in patients with advanced non–small-cell lung cancer (NSCLC) and PD ligand 1 (PD-L1) expression on at least 50% of tumor cells. The results of the second preplanned interim analysis of the phase 3 EMPOWER-Lung 1 clinical trial were presented at the 2020 virtual meeting of the European Society for Medical Oncology (ESMO).