FDA Pipeline: Designations in Kidney and Lung Cancers, Myelodysplastic Syndromes, and More
Over the past few weeks, the U.S. Food and Drug Administration (FDA) has issued designations and accepted applications for novel agents, as well as approved companion diagnostics. We summarize these regulatory movements below. Breakthrough Therapy Designation for MK-6482 in von Hippel-Lindau...
Ramaswamy Govindan, MD, on Differences Among Male and Female Patients With Lung Cancer
Ramaswamy Govindan, MD, of Washington University School of Medicine, discusses sex differences in lung cancer, including variations in treatment response, and the state of research in the field (Session ED20).
Pyrotinib for Pretreated Patients With HER2-Mutated Advanced NSCLC
In a Chinese phase II trial reported in the Journal of Clinical Oncology, Zhou et al found that pyrotinib produced durable responses in patients with HER2-mutated advanced non–small cell lung cancer (NSCLC) who had received prior platinum-based chemotherapy. Study Details The multicenter study...
Modeling Study Aims to Estimate the Effect of the COVID-19 Pandemic on Cancer Deaths in England
In a population-based modeling study reported in The Lancet Oncology, Maringe et al estimated that delays in diagnosis due to the COVID-19 pandemic could result in 3,291 to 3,621 additional deaths from breast, colorectal, esophageal, and lung cancers within 5 years. As stated by the investigators,...
Anti-TIGIT Antibody Plus Atezolizumab Move Forward in Advanced NSCLC
Tiragolumab, an anti-TIGIT antibody, plus the PD-L1 inhibitor atezolizumab exhibited early clinical activity and was tolerated in patients with advanced solid tumors, including those with metastatic non–small cell lung cancer (NSCLC) that was PD-L1–positive and untreated with prior checkpoint...
Treatment of Mesothelioma
Hear from thoracic oncology experts Drs. Ramaglingam, Brahmer, and Wakelee about the current and emerging treatment landscape for mesothelioma. In this video, they discuss first-line treatment data from the DREAM, PrECOG, and CheckMate 743 trials, as well as second-line gemcitabine plus ramucirumab in the RAMES trial.
Treatment of Small Cell Lung Cancer
In this video, Drs. Ramaglingam, Brahmer, and Wakelee discuss the latest in emerging data on the treatment of small cell lung cancer. They highlight several recent clinical trials, including IMpower133, CASPIAN, ECOG-ACRIN EA5161, and KEYNOTE-604 in the first-line setting, and phase II data on lurbinectedin in the second-line treatment setting.
Treatment of KRAS G12C Mutation
Drs. Ramalingam, Brahmer, and Wakelee review the role of KRAS G12C mutation in lung cancer, which is found is 13% of all non–small cell lung cancer. They highlight two investigational therapies, AMG 510 and MRTX 849, and discuss recently presented data.
Adjuvant EGFR Inhibition
Listen to three experts in the field of thoracic oncology—Drs. Ramalingam, Brahmer, and Wakelee—discuss the latest advances in the treatment of EGFR-mutant, early-stage non–small cell lung cancer, including recent data from the ADAURA and CTONG1104 trials, both presented during the ASCO20 Virtual Scientific Program.
Combination Immunotherapy Approaches
In this video, Drs. Ramalingam, Brahmer, and Wakelee discuss the latest in emerging data on chemo/immunotherapy and immunotherapy-based combination approaches for the treatment of non–small cell lung cancer. They review recent data presented during the ASCO20 Virtual Scientific Program, including CheckMate 227 and CheckMate 9LA, as well as the associated clinical implications.
A Diagnosis of Advanced Lung Cancer Is No Longer a Death Sentence
In hindsight, the symptoms I began experiencing in the winter of 2013, including pains in my chest and shoulders and a persistent cough, should have rung loud alarm bells. However, having undergone a pancreatectomy and splenectomy to cure a history of mucinous cystic neoplasms of the pancreas 5...
Lurbinectedin in Previously Treated Metastatic Small Cell Lung Cancer
On June 15, 2020, the alkylating drug lurbinectedin was granted accelerated approval for treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression during or after platinum-based chemotherapy.1,2 Supporting Efficacy Data Accelerated approval was based on...
Small Goals, Big Victories
While working toward the goal of conquering cancer, patients often celebrate smaller victories. These wins can range from spending a holiday weekend with family to taking a vacation without restrictions. Jyoti Malhotra, MD, MPH, is a 2015 Young Investigator Award (YIA) recipient helping patients...
Yale Cancer Center Awarded NIH SPORE Renewal for Lung Cancer Research
Yale Cancer Center researchers were awarded an $11 million grant renewal from the National Institutes of Health to fund the Yale Specialized Program of Research Excellence (SPORE) in Lung Cancer. SPORE harnesses the strengths of academic cancer centers by bringing together experts in oncology,...
ctDNA Clearance Predicts Progression-Free Survival With Osimertinib/Savolitinib in EGFR-Mutant, MET-Amplified NSCLC
Circulating tumor DNA (ctDNA) clearance of EGFR mutation—that is, detectable mutation at baseline that became undetectable or dropped below a predetermined threshold—appears to be predictive of extended progression-free survival for patients with EGFR-mutant, MET-amplified non–small cell lung...
Can Radiomics Predict Survival in Patients With NSCLC Receiving Immunotherapy?
Immunotherapy with immune checkpoint inhibitors has made great strides in the treatment of many cancers, but only between 25% and 50% of patients respond with clinical benefit, and these agents come with adverse events and high price tags. Thus, preselection of patients who are likely to respond to ...
Nivolumab/Ipilimumab Shows Benefit in Patients With Non–Small Cell Lung Cancer and Brain Metastases
The combination of nivolumab plus ipilimumab was at least as effective as chemotherapy in front-line therapy for patients with advanced non–small cell lung cancer (NSCLC) and brain metastases at baseline, according to the results of a post hoc analysis from part 1 of the phase III CheckMate 227...
Nasser K. Altorki, MD, on Lung Cancer: Radiotherapy and Immune Checkpoint Blockade in the Neoadjuvant Setting
Nasser K. Altorki, MD, of Weill Cornell Medical College, discusses study findings that suggest neoadjuvant low-dose focal stereotactic body radiation plus immune checkpoint blockade (ICB) is safe and causes no surgical delays in early-stage lung cancer, and that major pathologic response rates are likely to be comparable to those with chemotherapy/ICB combinations (Session ED37).
Study Links Mental Health Treatment to Possible Improved Cancer Survival
For people with cancer who have a mental health disorder, getting mental health treatment may help them live longer, a new study published by Berchuck et al in JAMA Oncology suggests. In the retrospective study, of more than 50,000 veterans treated for lung cancer within the Veterans Affairs (VA)...
Lung Cancer in Nonsmoking Individuals: Differences in Genetics and Response to Treatment
Lung cancer in nonsmokers is a diverse and distinct disease from lung cancer in smokers and is likely to respond differently to targeted treatments, according to results from a new study published by Chen et al in the journal Cell. Scientists studied a patient population in Taiwan with high rates...
Atezolizumab as First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression and No EGFR or ALK Aberrations
On May 18, 2020, atezolizumab was approved for the first-line treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations. High PD-L1 expression is defined as PD-L1 staining of at least 50% of...
Do Not Rush to High-Dose Twice-Daily Radiation for Limited Small Cell Lung Cancer
Bjørn Henning Gronberg, MD, PhD, presented a paper at the ASCO20 Virtual Scientific Program reporting astounding positive results favoring higher-dose, twice-daily radiation therapy in limited-stage small cell lung cancer.1 This was a phase II study (large for phase II but small for phase III)...
Lung Cancer Research Foundation Names Trudy Oliver, PhD, to Its Scientific Advisory Board
The Lung Cancer Research Foundation (LCRF) recently announced that Trudy Oliver, PhD, has joined its Scientific Advisory Board. Dr. Oliver is Associate Professor of Oncological Sciences at the University of Utah’s Huntsman Cancer Institute (HCI), where she has served since 2011, and is an HCI...
Phase II Study Evaluates Chemotherapy and Immunotherapy in Patients With Malignant Pleural Mesothelioma
Data from the phase II PrE0505 multicenter trial showed that adding durvalumab, an immune checkpoint antibody targeting programmed cell death ligand 1 (PD-L1), to the combination of cisplatin and pemetrexed chemotherapy improved outcomes in previously untreated patients with unresectable malignant...
Nivolumab Plus Ipilimumab in Two New Lung Cancer Indications
The combination of nivolumab and ipilimumab was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non–small cell lung cancer (NSCLC) in two different regimens: On May 15, 2020, the two-drug combination was approved for first-line treatment in...
USPSTF Issues Draft Recommendation Statement on Screening for Lung Cancer
On July 7, the U.S. Preventive Services Task Force (USPSTF) posted a draft recommendation statement, draft evidence review, and draft modeling study on screening for lung cancer in people who do not have signs or symptoms. Based on the evidence, the USPSTF recommends annual screening using a...
Expert Point of View: Scott N. Gettinger, MD
Discussant for the CheckMate 227 and CheckMate 9LA trials, Scott N. Gettinger, MD, of Yale Cancer Center in New Haven, Connecticut, said: “There is tremendous interest in lung cancer to combine nivolumab plus ipilimumab, driven by the melanoma experience. However, combinations of immunotherapy come ...
First-Line Nivolumab Plus Ipilimumab Shows Activity in NSCLC, With or Without Chemotherapy
Advanced non–small cell lung cancer (NSCLC) in patients whose tumors have no EGFR or ALK alterations poses a particular challenge in terms of first-line therapy. The use of nivolumab plus ipilimumab as well as nivolumab/ipilimumab plus two cycles of chemotherapy, respectively, as first-line therapy ...
Expert Point of View: Lecia V. Sequist, MD
Lecia V. Sequist, MD, who was not involved in the ADAURA study, said this could be a practice-changing study. Dr. Sequist is the Landry Family Professor of Medicine at Harvard Medical School and Director of the Center for Innovation in Early Cancer Detection at Massachusetts General Hospital....
Conference Highlights From the ASCO20 Virtual Scientific Program
The global outbreak of the COVID-19 pandemic forced many cancer societies, including ASCO, to cancel their in-person meetings this year and instead present the latest advancements and new approaches in oncology care via a virtual platform. For the first time in its 56-year history, the ASCO Annual...
Expert Point of View: Lynn Schuchter, MD, FASCO, and Ravi Salgia, MD, PhD
LYNN M. SCHUCHTER, MD, FASCO, Chief of Hematology/Oncology at the Penn Medicine’s Abramson Cancer Center, Philadelphia, was optimistic about the vaccine approach in this study. “We have seen broad use of PD-1 and PD-L1 agents across a range of cancers, and it makes sense to combine the immune...
Mortality Risk in Patients With COVID-19 and Thoracic Malignancies: Initial Report From the TERAVOLT Registry Study
As reported in The Lancet Oncology by Marina C. Garassino, MD, and colleagues, initial findings from the Thoracic Cancers International COVID-19 Collaboration (TERAVOLT) registry study have identified potential factors associated with increased risk of mortality in patients infected with COVID-19...
Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation
On May 6, 2020, the oral mesenchymal-epithelial transition (MET) kinase inhibitor capmatinib was granted accelerated approval for the treatment of adult patients who have metastatic non–small cell lung cancer (NSCLC) with tumors that have a mutation that leads to MET exon 14 skipping, as detected...
Brigatinib for ALK-Positive Metastatic Non–Small Cell Lung Cancer
On May 22, 2020, brigatinib was approved for the treatment of adult patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion...
Ramucirumab Plus Erlotinib in Treatment of EGFR-Mutant Metastatic NSCLC
On May 29, 2020, ramucirumab was approved for use in combination with erlotinib for first-line treatment of metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.1,2 Supporting Efficacy Data Approval was based on findings from the...
First-Line Pembrolizumab Added to Standard Chemotherapy Improved Progression-Free Survival in Extensive-Stage Small Cell Lung Cancer
Pembrolizumab added to etoposide and platinum significantly improved progression-free survival compared with placebo and etoposide/platinum as first-line therapy in patients with newly diagnosed, extensive-stage small cell lung cancer (SCLC).1 These results from the randomized, double-blind, phase...
Positive Findings in NSCLC for First-Line Nivolumab Plus Ipilimumab With or Without Chemotherapy
It is becoming more challenging to select first-line therapy for advanced non–small cell lung cancer (NSCLC) for patients whose tumors have no EGFR or ALK alterations. The results of two different studies presented at the ASCO20 Virtual Scientific Program—CheckMate 227 and CheckMate 9LA—support the ...
Egbert F. Smit, MD, PhD, on NSCLC: Treatment With Fam-trastuzumab Deruxtecan
Egbert F. Smit, MD, PhD, of the Netherlands Cancer Institute, discusses interim results from the DESTINY-Lung01 trial of fam-trastuzumab deruxtecan in patients with HER2-mutated metastatic non–small cell lung cancer. The data show clinical activity with high overall response rates and durable responses (Abstract 9504).
SIR 2020 Virtual: Transarterial Chemoperfusion for Patients With Mesothelioma
A novel treatment for patients with advanced mesothelioma is safe and effective and may improve the quality of life for patients who have few treatment options, according to a research abstract presented during a virtual session of the Society of Interventional Radiology (SIR) 2020 Annual...
First-Line Stereotactic Radiosurgery vs Whole-Brain Radiotherapy for SCLC Brain Metastases
In a cohort analysis reported in JAMA Oncology, Rusthoven et al found that first-line stereotactic radiosurgery was associated with similar outcomes as whole-brain radiotherapy in patients with small cell lung cancer (SCLC) brain metastases. As stated by the investigators, “Although stereotactic...
Impact of Medicare OCM Reporting Requirements on Biomarker Testing and Treatment in Advanced NSCLC
In a study reported in JCO Oncology Practice, Emily H. Castellanos, MD, MPH, and colleagues found that the requirement for Medicare Oncology Care Model (OCM) practices to report biomarker testing of patients with advanced non–small cell lung cancer (NSCLC) has not substantially altered the...
Suresh S. Ramalingam, MD, on NSCLC: Nivolumab Plus Ipilimumab vs Chemotherapy
Suresh S. Ramalingam, MD, of Emory University, discusses a 3-year update from the CheckMate 227, Part 1, trial, which showed that nivolumab plus ipilimumab continued to provide durable and long-term overall survival benefit vs platinum-doublet chemotherapy as first-line treatment for patients with advanced non–small cell lung cancer (Abstract 9500).
Rachel E. Sanborn, MD, on NSCLC: Maximizing the Benefits of Targeted Therapies for EGFR-Mutated Disease
Rachel E. Sanborn, MD, of the Providence Cancer Institute, discusses three key abstracts on EGFR-mutated non–small cell lung cancer: a final overall survival analysis of bevacizumab plus erlotinib; concurrent osimertinib plus gefitinib for first-line treatment; and first-line treatment with a tyrosine kinase inhibitor with or without aggressive upfront local radiation therapy (Abstracts 9506, 9507, 9508).
First-Line Osimertinib/Bevacizumab for Metastatic EGFR-Mutant Lung Cancer
In the phase II portion of a single-center phase I/II trial reported in JAMA Oncology, Yu et al found that the combination of first-line osimertinib and bevacizumab resulted in a high rate of 1-year progression-free survival in patients with metastatic EGFR-mutant lung cancer. As stated by the...
FDA Grants Accelerated Approval to Lurbinectedin for Metastatic SCLC
On June 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lurbinectedin (Zepzelca) for adult patients with metastatic small cell lung cancer (SCLC) whose disease progressed on or after platinum-based chemotherapy. PM1183-B-005-14 Trial Efficacy was demonstrated in the...
Addition of Pemetrexed vs Vinorelbine to Adjuvant Cisplatin for Nonsquamous NSCLC
In the Japanese phase III JIPANG trial reported in the Journal of Clinical Oncology, Kenmotsu et al found that adjuvant therapy with pemetrexed/cisplatin did not result in superior recurrence-free survival but was better tolerated than vinorelbine/cisplatin in patients with completely resected...
FDA Approves Combination Regimens in NSCLC, HCC
On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved two combination regimens: ramucirumab (Cyramza) was approved in combination with erlotinib for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)...
Selpercatinib for Lung and Thyroid Cancers With RET Gene Mutations or Fusions
On may 8, 2020, selpercatinib was granted accelerated approval for the following indications: Adult patients with metastatic RET fusion-positive non–small cell lung cancer (NSCLC) Adult and pediatric patients ≥ 12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer who...
Leora Horn, MD, on Thoracic Cancer and COVID-19: How Type of Cancer Therapy May Affect Survival
Leora Horn, MD, of Vanderbilt University, discusses the results of the TERAVOLT study, launched by the Thoracic Cancers International COVID-19 Collaboration. It examined the impact of specific chemotherapy and immunotherapy regimens on hospitalization and risk of death in patients with thoracic malignancies who are also infected with COVID-19 (Abstract LBA111).
Safety and Patient-Reported Outcomes From the IMpower150 Trial in Metastatic Nonsquamous NSCLC
A safety and patient-reported outcome analysis from the IMpower150 trial, reported in the Journal of Clinical Oncology by Martin Reck, PhD, and colleagues, indicated that atezolizumab plus bevacizumab and chemotherapy appeared to be a manageable and tolerable regimen when compared with atezolizumab ...
