Tremelimumab Plus Durvalumab and Platinum-Based Chemotherapy Approved for Metastatic NSCLC

The FDA has approved tremelimumab (Imjudo®, AstraZeneca) in combination with durvalumab (Imfinzi®, AstraZeneca) and platinum-based chemotherapy for patients with metastatic non–small cell lung cancer (NSCLC) who have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Tremelimumab is a fully human immune checkpoint inhibitor against CTLA-4. "Although some patient subsets, such as those with higher levels of tumor programm...

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Cemiplimab-rwlc Approved for Treatment of Non–Small Cell Lung Cancer

The FDA has granted approval of cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.) in combination with platinum-based chemotherapy for treatment of advanced non–small cell lung cancer (aNSCLC) with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS proto-oncogene 1 (ROS1) aberrations, and no prior systemic treatment. Cemiplimab-rwlc is a fully human immune checkpoint inhibitor targeting the programmed cell death receptor-1 (PD-1). "Pembrolizumab and ate...

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Harnessing Immunotherapy-Based Strategies for Advanced Non–Small Cell Lung Cancer With Ticiana Leal, MD, and Beth Sandy, MSN, CRNP

Oncology Data Advisor™ · Harnessing Immunotherapy-Based Strategies for Advanced Non–Small Cell Lung Cancer An estimated 236,740 new cases of lung cancer are reported in the United States annually, and 130,180 people die of the disease. Approximately 84% of cases are classified as non–small cell lung cancer (NSCLC) (ACS, 2022). Though new screening procedures have identified more lung cancers at an earlier stage, most patients are still diagnosed at a locally advanced or metast...

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Optimizing Management of Metastatic Squamous Non–Small Cell Lung Cancer With Mark Kris, MD, and Victoria Sherry, DNP, CRNP, AOCNP®

Oncology Data Advisor™ · Optimizing Management of Metastatic Squamous Non-Small Cell Lung Cancer Squamous cell lung carcinoma is a distinct histologic subtype of non–small cell lung cancer (NSCLC) that accounts for approximately 25% to 30% of all NSCLC cases and is associated with approximately 30% shorter survival compared with other subtypes of the disease. Because alterations and mutations for which targeted therapies are approved are uncommon in squamous cell NSCLC, treatment re...

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Capmatinib Granted Regular Approval for Metastatic Non–Small Cell Lung Cancer

The FDA has granted regular approval to capmatinib (Tabrecta®, Novartis Pharmaceuticals Corp.) for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) who have tumors evolving into the mesenchymal-epithelial transition exon 14 skipping (METex14) mutation. Capmatinib was previously granted accelerated approval in May 2020 based on initial data from the GEOMETRY mono-1 trial (NCT02414139); due to updated results, the FDA is now converting it to regular approval. "Activat...

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Trastuzumab Deruxtecan First Approval for HER2-Mutant Non–Small Cell Lung Cancer

The FDA has granted accelerated approval to fam-trastuzumab deruxtecan-nxki (T-DXd) (Enhertu®, Daiichi Sankyo Inc.) for treatment of adult patients with unresectable or metastatic non–small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER2) mutations. This approval is specific to individuals who have undergone previous systemic therapy. Trastuzumab deruxtecan is the first drug to be approved for treatment of HER2-mutant NSCLC. "HER2 mutations are an established molecul...

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Dissolving Knowledge Gaps Regarding EGFR Exon 20 Insertion–Mutant NSCLC

An educational enduring activity and podcast provided by i3 Health has demonstrated knowledge gains and learning outcomes regarding new perspectives on diagnosis and treatment of epidermal growth factor receptor (EGFR) exon 20 insertion–mutant non–small cell lung cancer (NSCLC). Lung cancer is the second most common cancer in the United States, with 84% of lung cancers being classified as NSCLC. According to the American Cancer Society, in 2022 there are an estimated 236,740 new cases of lung ca...

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Supporting Educational Needs in Treatment of Advanced Non–Small Cell Lung Cancer

An educational enduring activity provided by i3 Health demonstrated significant learning outcomes in the selection of treatment for patients with anaplastic lymphoma kinase (ALK)–positive advanced non–small cell lung cancer (NSCLC). This activity was created to advise clinicians on the development of individualized treatment plans based on the best available evidence and emerging guideline recommendations. Lung cancer is the second most common cancer in the United States, and the first most dead...

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FDA Approves Nivolumab as Neoadjuvant Therapy for Resectable Non–Small Cell Lung Cancer

 The FDA has approved nivolumab (Opdivo®, Bristol-Myers Squibb) in combination with platinum doublet chemotherapy for the treatment of adult patients with early-stage, resectable non–small cell lung cancer (NSCLC). Nivolumab is a fully human programmed cell death ligand 1 (PD-L1)–targeted antibody, and its use is approved without regard for PD-L1 expression level. "In patients with nonmetastatic NSCLC, surgery has curative potential, but 30% to 80% who undergo resection experience recurrenc...

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New Perspectives on Diagnosis and Treatment of EGFR Exon 20 Insertion–Mutant NSCLC With Helena Yu, MD, and Maria Arcila, MD

An estimated 235,760 new cases of lung cancer are reported in the United States annually, and 131,880 people die of the disease. Approximately 84% of cases are classified as non-small cell lung cancer (NSCLC) (ACS, 2021). The most frequent genomic aberration among patients with NSCLC is the epidermal growth factor receptor (EGFR) mutation, approximately 2%-10% of which are exon 20 insertion mutations (Kumari et al, 2019; Dersarkissian et al, 2019). Exon 20 insertion mutations are a heterogenous ...

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FDA Approves Atezolizumab for Non–Small Cell Lung Cancer

The FDA has granted approval to atezolizumab (Tecentriq®, Genentech) for the adjuvant treatment of patients with stage II to IIIA non–small cell lung cancer (NSCLC) whose tumors have a programmed death ligand 1 (PD-L1) expression on ≥1% of tumor cells. Atezolizumab is approved for use following resection and platinum-based chemotherapy in this patient population.The FDA has also approved the VENTANA PD-L1 (SP263) Assay (Ventana Medical Systems), a diagnostic device that will select patients with...

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FDA Approves Mobocertinib for EGFR Exon 20 Insertion–Mutated NSCLC

The FDA has approved mobocertinib (Exkivity™, Takeda) for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.In addition, the FDA has approved the OncomineTM Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to determine eligibility for treatment with mobocertinib."EGFR exon 20 insertion mutations ...

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Amivantamab-vmjw Approved for EGFR Exon 20–Mutant Non-Small Cell Lung Cancer

The FDA has approved amivantamab-vmjw (Rybrevant®, Janssen) for patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. "Despite sharing similar tumor biology to other EGFR-mutant NSCLC tumors, no targeted therapies have been approved for NSCLC harboring EGFR exon 20 insertion mutations," wrote Joshua K. Sabari, MD, medical oncologist at NYU Medical Oncology Associates and colleagues, in the abstract presented in January at the W...

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Addressing Gaps in Knowledge of Management of Non-Small Cell Lung Cancer

Lung cancer is diagnosed in approximately 235,760 individuals in the United States each year, and 131,880 people die of the disease annually. Non-small cell lung cancer (NSCLC), which accounts for 84% of these cases, has a dismal 5-year survival rate of 18%, and most patients will develop progressive disease within 5 months of their final cycle of first-line classical doublet chemotherapy. The use of tumor histology in determining optimal treatment strategies and relevant molecular biomarkers ha...

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Camrelizumab for Advanced Squamous Non-Small Cell Lung Carcinoma: Caicun Zhou, MD, PhD

Recently, the results of a phase 3 trial on camrelizumab were published in the Journal of Thoracic Oncology and presented at the European Lung Cancer Virtual Congress 2021. Camrelizumab was studied in the randomized, double-blind, multicenter trial as a treatment for advanced squamous non-small cell lung carcinoma (NSCLC). Patients with stages IIIB-IV squamous NSCLC were treated with carboplatin plus paclitaxel with camrelizumab or placebo in the first-line setting. Compared with those who recei...

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Atezolizumab for Previously Treated Non-Small Cell Lung Cancer: Julien Mazières, MD, PhD

For patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC), effective treatment options with minimal toxicity remain limited. In this interview with i3 Health, Julien Mazières, MD, PhD, Professor of Respiratory Medicine at Toulouse University Hospital, discusses his collaborative research finding that atezolizumab increases long-term overall survival compared with docetaxel, regardless of histology, subsequent immunotherapy, and programmed death ligand...

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Cemiplimab for First-line Treatment of Advanced Non-Small Cell Lung Cancer: Ahmet Sezer, MD

Recently, the FDA granted approval to cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small lung cancer cell (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in at least 50% of their cells and whose tumors do not have aberrations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or C-ROS oncogene 1 (ROS1). In this interview, Ahmet Sezer, MD, Professor in the Department of Medical Onco...

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Roy Herbst, MD, PhD: Adjuvant Osimertinib for EGFR-Mutated Non-Small Cell Lung Cancer

Recently, the FDA approved osimertinib (Tagrisso®, AstraZeneca) as the first adjuvant therapy for patients with surgically resected early-stage non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. In this interview, Roy Herbst, MD, PhD, Chief of Medical Oncology at Yale Cancer Center and lead investigator of the ADAURA trial, on which the approval was based, speaks with i3 Health about the significance of the approval of osimertinib for this patient populati...

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Lorlatinib Approved for Metastatic ALK-Positive Non-Small Cell Lung Cancer

The FDA has approved lorlatinib (Lorbrena®, Pfizer, Inc.) for the treatment of patients with anaplastic lymphoma kinase (ALK)–positive non-small cell lung cancer (NSCLC). A subset of NSCLCs defined by their chromosomal rearrangements of the ALK gene are highly sensitive to small-molecule ALK tyrosine kinase inhibitors (TKIs). Lorlatinib is a novel third-generation small-molecule ALK TKI that was designed to cross the blood-brain barrier in an effort to better treat patients whose disease has pro...

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Cemiplimab-rwlc Approved for Non-Small Cell Lung Cancer With High PD-L1 Expression

The FDA has approved cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.), a programmed cell death protein 1 (PD-1) inhibitor, for the first-line treatment of patients with advanced non-small lung cancer cell (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in at least 50% of their cells and whose tumors do not have aberrations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or C-ROS oncogene 1 (ROS1). "An estimated 25% to 35% of advanced NSCLC ...

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