FDA Approves Lorlatinib for Metastatic ALK-Positive NSCLC
On March 3, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena) for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. The FDA also approved the...
Study Examines Extrapleural Pneumonectomy After IMRT for Malignant Pleural Mesothelioma
In a Canadian single-center phase II feasibility study reported in The Lancet Oncology, Cho et al found that a treatment protocol (surgery for mesothelioma after radiotherapy, also known as SMART) consisting of hemithoracic intensity-modulated radiotherapy (IMRT) followed by extrapleural...
Pembrolizumab's Indication in Small Cell Lung Cancer Is Withdrawn
On March 1, Merck announced the company is voluntarily withdrawing the U.S. indication for pembrolizumab (Keytruda) for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The ...
EMPOWER-Lung 1: First-Line Cemiplimab-rwlc vs Platinum-Doublet Chemotherapy in Advanced NSCLC With PD-L1 Expression ≥ 50%
As reported in The Lancet by Sezer et al, the phase III EMPOWER-Lung 1 trial has shown improved overall and progression-free survival with cemiplimab-rwlc vs platinum doublet chemotherapy among patients with advanced non–small cell lung cancer (NSCLC) with PD-L1 expression on ≥ 50% of tumor cells...
KEYNOTE-598: No Improvement With Addition of Ipilimumab to Pembrolizumab in NSCLC
In the phase III KEYNOTE-598 study, the addition of ipilimumab to pembrolizumab increased toxicity without boosting efficacy as first-line therapy for metastatic non–small cell lung cancer (NSCLC) in patients with high expression of PD-L1. The findings were presented at the International...
Phase II CodeBreak 100 Validates Benefit of KRAS Inhibitor Sotorasib in Advanced Lung Cancer
The registrational phase II CodeBreak 100 trial has validated the power of KRAS inhibition with sotorasib (AMG 510) in advanced non–small cell lung cancer (NSCLC).1 In a follow-up to the groundbreaking findings of the phase I trial, the phase II cohort has now shown a durable response rate of...
FDA Approves Cemiplimab-rwlc for Patients With NSCLC and High PD-L1 Expression
On February 22, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] > 50%) as determined by an FDA-approved...
NEOSTAR: Neoadjuvant Nivolumab or Nivolumab/Ipilimumab in Operable NSCLC
The randomized phase II NEOSTAR trial, which examined single-agent and combined neoadjuvant immune checkpoint inhibitor therapy in patients with stage I to III non–small cell lung cancer (NSCLC), found combination therapy produced a significant clinical benefit (as assessed by major pathologic...
Roy S. Herbst, MD, PhD, on LUNG-MAP, Circulating Tumor DNA, and Tissue Molecular Analysis
Roy S. Herbst, MD, PhD, of Yale University, discusses results from the LUNG-MAP Master Protocol, which support the planned use of circulating tumor DNA for enrollment onto LUNG-MAP substudies, with a positive finding meriting inclusion in study; a negative finding, while considered inconclusive, requires the use of tissue samples (Abstract MA08.10).
FDA Pipeline: Priority Reviews in KRAS G12C–Mutated NSCLC, Non–Muscle-Invasive Bladder Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for KRAS G12C–mutated non–small cell lung cancer (NSCLC) and high-risk, bacillus Calmette-Guérin–unresponsive non–muscle-invasive bladder cancer. A new drug application for a therapy for Waldenström’s...
KEYNOTE-598 Trial: Addition of Ipilimumab to Pembrolizumab in Previously Untreated Patients With Metastatic NSCLC and High PD-L1 Expression
As reported in the Journal of Clinical Oncology by Michael Boyer, MBBS, PhD, and colleagues, an interim analysis in the phase III KEYNOTE-598 trial showed no improvement in overall or progression-free survival with the addition of ipilimumab to pembrolizumab in previously untreated patients with...
FDA Approves Trilaciclib to Reduce Chemotherapy-Induced Bone Marrow Suppression in Adults Being Treated for SCLC
On February 12, the U.S. Food and Drug Administration (FDA) approved trilaciclib (Cosela) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer (SCLC)....
Martin Reck, MD, PhD, on SCLC: Maintenance Therapy for Patients With Extensive-Stage Disease
Martin Reck, MD, PhD, of LungenClinic, discusses results from the IMpower133 study of carboplatin plus etoposide with or without atezolizumab in patients with untreated extensive-stage small cell lung cancer (Abstract OA11.06).
Martin Reck, MD, PhD, on NSCLC: Pembrolizumab, Platinum Chemotherapy, and Radiotherapy in Advanced Disease
Martin Reck, MD, PhD, of the LungenClinic, discusses the results from KEYNOTE-799, which explored a new strategy to increase the intensity of treatment in patients with unresectable, locally advanced, stage III non–small cell lung cancer (Abstract OA02.03).
Nivolumab/Ipilimumab vs Chemotherapy as First-Line Treatment for Unresectable Malignant Pleural Mesothelioma: CheckMate 743 Trial
As reported in The Lancet by Paul Baas, MD, and colleagues, a prespecified interim analysis in the phase III CheckMate 743 trial has shown improved overall survival with first-line nivolumab/ipilimumab vs platinum-based chemotherapy in patients with unresectable malignant pleural mesothelioma. The...
Jill Feldman: A Determined Cancer Survivor Shares Her Story of a Family Devastated by Lung Cancer
Jill Feldman, a patient advocate who has lost five family members to lung cancer and is herself a 12-year cancer survivor living with EGFR-positive disease, describes her family history of cancer, how she has worked with her physicians for more than a decade to survive her own diagnosis, and the message she would like all oncologists to hear.
Luis M. Montuenga, PhD, on Noninvasive Biomarkers in Lung Cancer Screening
Luis M. Montuenga, PhD, of the University of Navarra, discusses the potential contributions of biomarkers, promising biomarker panels being tested and published, the need to standardize biospecimen collection, and how to improve the sensitivity of these biomarkers (Abstract PL05.06).
Bruce E. Johnson, MD, on Evolving Challenges in Lung Cancer Drug Development
Bruce E. Johnson, MD, of Dana-Farber Cancer Institute, offers his expert perspective on single-arm drug approvals for targeted agents between 2016 and 2020, the need for biomarker testing, and the societal costs of drug development (Abstract PL04.03).
Roy S. Herbst, MD, PhD, on NSCLC: Osimertinib and Patient-Reported Outcomes
Roy S. Herbst, MD, PhD, of Yale University, discusses two key abstracts from the ADAURA trial: the use of osimertinib as adjuvant therapy for resected EGFR-mutated non–small cell lung cancer; and patient-reported outcomes, which showed a benefit in disease-free survival and maintenance of health-related quality of life in patients with resected stage IB to IIIA disease (Abstracts OA06.04 and OA06.03).
Justin F. Gainor, MD, on NSCLC: Study Results on Nivolumab vs Ipilimumab, Bemcentinib Plus Pembrolizumab
Justin F. Gainor, MD, of Massachusetts General Hospital, discusses two key phase II studies on non–small cell lung cancer: nivolumab vs nivolumab plus ipilimumab in EGFR-mutant disease and the oral selective AXL inhibitor bemcentinib with pembrolizumab in advanced disease (Abstracts OA01.06 and OA01.07).
Martin Reck, MD, PhD, on NSCLC: Pembrolizumab Plus Ipilimumab in First-Line Treatment
Martin Reck, MD, PhD, of the LungenClinic, discusses findings of the KEYNOTE-598 study, which showed that pembrolizumab plus ipilimumab was more toxic and offered no more benefit in terms of efficacy than pembrolizumab plus placebo in first-line therapy for patients with metastatic high PD-L1–expressing non–small cell lung cancer (Abstract PS01.09).
First-Line Lorlatinib Improves Progression-Free Survival vs Crizotinib in Advanced ALK-Positive NSCLC
As reported in The New England Journal of Medicine by Alice T. Shaw, MD, PhD, Global Head of Translational Clinical Oncology at Novartis Institutes for BioMedical Research,* and colleagues, an interim analysis of the phase III CROWN trial has shown that first-line lorlatinib significantly improved...
Jill Feldman on Diversifying the Criteria for Inclusion in Clinical Trials
Jill Feldman, a patient advocate and lung cancer survivor, discusses the current challenges and potential solutions to including more people of color and those in underserved communities in clinical trial research (Abstract PL04.06).
Five-Year Outcomes From the CheckMate 017 and 057 Trials of Nivolumab vs Docetaxel in Previously Treated Patients With NSCLC
In an analysis of the phase III CheckMate 017 and 057 trials in previously treated patients with advanced squamous (017) and nonsquamous (057) non–small cell lung cancer (NSCLC), reported in the Journal of Clinical Oncology, Hossein Borghaei, DO, MS, and colleagues found pooled 5-year overall...
Fred R. Hirsch, MD, PhD, on Lung Cancer: Survival and Tumor Mutation Burden
Fred R. Hirsch, MD, PhD, of Mount Sinai Medical Center, discusses Lung-MAP studies in which a higher tumor mutation burden determined by next-generation sequencing was linked to overall and progression-free survival across two immunotherapy trials, and was independent of PD-L1 status (Abstract OA01.04).
HIC Assays May Aid in Predicting Response to Immunotherapy Among Patients With NSCLC
Using a host immune classifier (HIC) test for patients with non–small cell lung cancer (NSCLC) may provide better predictors of treatment response and improve outcomes, according to research presented by Akerley et al at the International Association for the Study of Lung Cancer (IASLC) 2020 World...
Impact of COVID-19 on Cancer Care Has Been ‘Profound,’ According to WHO
More than a year since the new coronavirus crisis began, its impact on cancer care has been stark, with “50% of governments (having) cancer services partially or completely disrupted because of the pandemic,” said André Ilbawi, MD, of the World Health Organization’s (WHO) Department of...
Germline Whole-Exome Sequencing Reveals the Potential Role of Hereditary Predisposition and Therapeutic Implications in SCLC
A study presented by Nobuyuki Takahashi, MD, of the Center for Cancer Research at the National Cancer Institute, at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore (Abstract OA11.05) demonstrated that there may be an inherited ...
Patient-Reported Outcomes From the CROWN Trial: First-Line Lorlatinib vs Crizotinib for ALK-Positive NSCLC
Patient-reported outcomes from the phase III CROWN study showed that time to treatment deterioration in chest pain, dyspnea, and cough was comparable between those who received lorlatinib and patients who took crizotinib. The research was presented at the International Association for the Study of...
Silvia Novello, MD, PhD, on NSCLC: Pharmacogenomics-Driven vs Standard Adjuvant Chemotherapy
Silvia Novello, MD, PhD, of the University of Turin, discusses phase III results from the ITACA trial, which explored the notion of improving survival by customizing treatment and reducing toxicities for patients with completely resected stage II to IIIA non–small cell lung cancer (Abstract PS01.04).
Taiwanese TALENT Study Supports Effectiveness of Low-Dose CT for Lung Cancer in Certain Populations
A study presented by researchers with the Ministry of Health and Welfare in Taiwan confirmed low-dose computed tomography (CT) screening may be feasible in a predefined, never-smoking, high-risk population. The research was presented at the International Association for the Study of Lung Cancer...
Two ADAURA Analyses Support the Use of Osimertinib in Patients With Surgically Resected NSCLC
Two presentations based on data from the ADAURA clinical trial advanced previous research that demonstrated improved disease-fee survival outcomes for patients with surgically resected non–small cell lung cancer (NSCLC) receiving osimertinib, while also maintaining quality of life. The data were...
FDA Grants Accelerated Approval to Tepotinib for Patients With Metastatic NSCLC and MET Exon 14–Skipping Alterations
On February 3, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko) for adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations. VISION Trial Efficacy was...
Dean Fennell, FRCP, PhD, on Mesothelioma: Nivolumab vs Placebo in Relapsed Disease
Dean Fennell, FRCP, PhD, of the University of Leicester, discusses phase III results from the CONFIRM trial, which sought a standard immunotherapy treatment to improve overall survival for patients with mesothelioma who have relapsed after taking pemetrexed and cisplatin. Globally, the incidence of mesothelioma is on the rise; in the United Kingdom alone, it has gone up nearly 500% since the 1970s (Abstract PS01.11).
WCLC Press Briefing Focuses on the Connection Between Lung Cancer and COVID-19
On February 27, 2020, the Journal of Thoracic Oncology published a case study that described two patients from Wuhan, China, who had recently underwent lung lobectomies for adenocarcinoma and were retrospectively found to have had COVID-19 at the time of surgery. Eleven months later, the lung...
Nivolumab Monotherapy Improves Survival in Patients With Relapsed Malignant Mesothelioma
In patients with relapsed malignant mesothelioma, treatment with single-agent nivolumab led to a significant improvement in both overall and progression-free survival in the phase III CONFIRM trial. These findings were presented by Dean A. Fennell, FRCP, PhD, Professor and Chair of Thoracic Medical ...
LCMC3 Trial: Neoadjuvant Atezolizumab for Patients With Stage IB to IIIB Resectable Lung Cancer
Neoadjuvant treatment with single-agent atezolizumab for patients with stage IB to IIIB lung cancer resulted in a major pathologic response rate of 21% and pathologic complete response rate of 7% in the primary analysis of the Lung Cancer Mutation Consortium 3 (LCMC3) study. The findings were...
Giorgio V. Scagliotti, MD, PhD, on Doubling the Lung Cancer Cure Rate by 2025: A Realistic Goal
Giorgio V. Scagliotti, MD, PhD, of the University of Torino, talks about why he believes that many more patients with lung cancer can be cured within the next 4 years, given decreases in mortality rates, widespread use of targeted treatments and immunotherapies, and earlier diagnoses as a result of systematic screening with low-dose CT (Abstract PL05.08).
Featured Presentations at WCLC Focus on Disparities in Patients With Lung Cancer
At a press briefing held by the International Association for the Study of Lung Cancer (IASLC), researchers presented new data that revealed factors relating to race, gender, sexual orientation, and income continue to be significant barriers to those living with lung cancer. The press briefing is...
Negative Findings in KEYNOTE-598: Ipilimumab Adds No Benefit to Pembrolizumab as First-Line Therapy for NSCLC With High PD-L1 Expression
In the phase III KEYNOTE-598 study, the addition of ipilimumab to pembrolizumab increased toxicity without boosting efficacy as first-line therapy for metastatic non–small cell lung cancer (NSCLC) in patients with high expression of PD-L1, according to research presented at International...
Phase II CodeBreak 100 Validates Early Benefit for KRAS Inhibitor in NSCLC
The phase II CodeBreak 100 trial has validated the power of KRAS inhibition with sotorasib (AMG 510) in patients with advanced non–small cell lung cancer (NSCLC). In a follow-up to phase I data, the phase II cohort of the study has now shown a durable response rate of 37.1%, a disease control rate...
‘State of Tobacco Control’ 2021 Report Says Ending Tobacco Use Is Critical, Especially During the COVID-19 Pandemic
Even amid the COVID-19 pandemic, tobacco use remains a serious public health threat. In addition to tobacco-related death and disease, smoking also increases the risk of the most severe impacts of COVID-19. The American Lung Association has released its 19th annual “State of Tobacco Control”...
CheckMate 9LA Trial: First-Line Nivolumab/Ipilimumab Plus Chemotherapy vs Chemotherapy Alone in Stage IV or Recurrent NSCLC
As reported in The Lancet Oncology by Luis Paz-Ares, MD, and colleagues, the phase III CheckMate 9LA trial has shown improved overall survival with first-line nivolumab/ipilimumab plus two cycles of chemotherapy vs four cycles of chemotherapy alone in patients with stage IV or recurrent non–small...
Single-Institution Study Examines Safety of Routine Thoracic Surgery, Examinations During the COVID-19 Pandemic
A study published by Wang et al in JTO Clinical and Research Reports compared surgeries performed at one Chinese hospital in 2019 with a similar date range during the COVID-19 pandemic. Researchers found that routine thoracic surgery and invasive examinations were performed safely during the...
Study Identifies Four Unique Subtypes of Small Cell Lung Cancer
Researchers have developed the first comprehensive framework to classify small cell lung cancer (SCLC) into four unique subtypes based on gene expression and have identified potential therapeutic targets for each type. These findings were published by Gay et al in Cancer Cell. SCLC is known for...
Osimertinib in Adjuvant Therapy for NSCLC With EGFR Mutations
On December 18, 2020, osimertinib was approved for adjuvant therapy after tumor resection in patients with non–small cell lung cancer (NSCLC) with tumors with EGFR exon 19 deletions or exon 21 L858R mutations, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Supporting...
IMpower133 Update: Atezolizumab Plus Carboplatin/Etoposide for Extensive-Stage Small Cell Lung Cancer
As reported in the Journal of Clinical Oncology by Stephen V. Liu, MD, and colleagues, an updated overall survival analysis in the phase I/III IMpower133 trial showed continued benefit with the addition of atezolizumab to carboplatin/etoposide as first-line treatment in patients with...
Prevalence of KRAS G12C Somatic Mutations by Cancer Type, Race, and Sex
In a study reported in a letter to the editor in The New England Journal of Medicine, Nassar et al identified the prevalence of the formerly “undruggable” KRAS G12C mutation across tumor types, race, and sex. As stated by the investigators, a recently reported early-phase clinical trial has shown...
Record Drop in Cancer Mortality for Second Straight Year Due to Improved Lung Cancer Treatment Reported in ‘Cancer Statistics, 2021’
Overall cancer death rates in the United States dropped continuously from 1991 through 2018, for a total decrease of 31%, including a 2.4% decline from 2017 to 2018. These findings were reported in the American Cancer Society’s “Cancer Statistics, 2021” article, published by Rebecca L. Siegel, MPH, ...
Transmission of Maternal Cancer in Two Infants From Mothers With Cervical Cancer During Delivery
In a brief report published in The New England Journal of Medicine, Arakawa et al described the identification of lung cancer in two children that likely resulted from transmission of maternal cervical cancer tumor cells during vaginal delivery. As noted by the investigators, the transmission of...
