Lung Cancer

Madrid, Spain—A perioperative regimen of neoadjuvant nivolumab (Opdivo) plus chemotherapy followed by surgery and adjuvant nivolumab demonstrated a statistically significant and clinically meaningful improvement in event-free survival versus neoadjuvant chemotherapy plus placebo followed by surgery and adjuvant placebo in patients with resectable non–small cell lung cancer.
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Madrid, Spain—Results from 3 phase 3 clinical trials demonstrated the superiority of targeted therapies over conventional chemotherapy in patients with oncogene-addicted non–small cell lung cancer (NSCLC), including ALK-positive advanced NSCLC; EGFR exon 20 insertion-mutation–positive, newly diagnosed or advanced NSCLC; and advanced RET fusion–positive NSCLC. These findings were reported during the European Society for Medical Oncology Congress 2023.
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On August 9, 2023, the FDA granted regular approval to pralsetinib (Gavreto; Genentech), a kinase inhibitor of wild-type RET and oncogenic RET fusions and mutations, for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) and RET fusion–positive gene mutation, as detected by an FDA-approved test.
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On January 26, 2023, the FDA approved pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, as monotherapy for adjuvant treatment of patients with stage IB (T2a ≥4 cm), II, or IIIA non–small-cell lung cancer (NSCLC), after resection and platinum-based chemotherapy.
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On December 12, 2022, the FDA accelerated the approval of adagrasib (Krazati; Mirati Therapeutics), a RAS GTPase inhibitor, for adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) and KRASG12C mutation (as determined by an FDA-approved test) who have received at least 1 systemic therapy.
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Two weeks after the initial approval of tremelimumab (Imjudo; AstraZeneca), a CTLA-4 monoclonal antibody, on November 10, 2022, the FDA approved this new immunotherapy, in combination with the PD-L1 inhibitor durvalumab (Imfinzi; AstraZeneca) and platinum-based chemotherapy, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and no EGFR or ALK genomic alterations.
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For this supplement, expert faculty provided detailed perspectives based on their extensive experience in the management of non–small cell lung cancer (NSCLC), focusing on the incorporation and importance of biomarker testing in precision medicine for improved patient care.
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Sotorasib (Lumakras) continues to demonstrate durable efficacy in non–­small-cell lung cancer (NSCLC) with KRAS p.G12C mutation at 2-year follow-up of the phase 2 CodeBreaK 100 clinical trial.
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On September 15, 2021, the FDA accelerated the approval of mobocertinib (Exkivity; Takeda Pharmaceuticals), a tyrosine kinase inhibitor, for the treatment of adults with locally advanced or metastatic non−small-cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by the FDA-approved Oncomine Dx Target Test (Life Technologies Corporation), which was approved on the same day as a companion diagnostic for mobocertinib. The FDA granted mobocertinib priority review, breakthrough therapy designation, and orphan drug designation.
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Approximately 13% of patients with lung adenocarcinoma harbor the KRAS p.G12C mutation, which is associated with poor clinical outcomes. During the American Society of Clinical Oncology 2021 virtual annual meeting, Ferdinandos Skoulidis, MD, PhD, MRCP, Assistant Professor, Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, provided updated results from the phase 2 component of the CodeBreaK 100 clinical trial, which evaluated sotorasib (Lumakras), a small-molecule inhibitor of the KRAS p.G12C mutation, in previously treated patients with non–small-cell lung cancer (NSCLC) whose tumors express this aberration. These results were simultaneously published in the New England Journal of Medicine.
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