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skin cancer
immunotherapy

Pembrolizumab Shows Durable Antitumor Activity in Both Locally Advanced and Recurrent/Metastatic Squamous Cell Carcinomas

The results of the second interim analysis of the KEYNOTE-629 study of pembrolizumab in cutaneous squamous cell carcinoma confirmed durable antitumor activity in both the locally advanced and the recurrent/metastatic settings. Adverse events with pembrolizumab were generally consistent with its...

lung cancer

Lorlatinib for Metastatic ALK-Positive NSCLC

On March 3, 2021, lorlatinib was granted regular approval for treatment of patients with metastatic non–small cell lung cancer (NSCLC) with ALK-positive tumors as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA simultaneously approved the Ventana ALK (D5F3) CDx Assay ...

solid tumors
gastroesophageal cancer

Pembrolizumab Combined With Chemotherapy for Advanced Esophageal or Gastroesophageal Junction Carcinoma

On March 22, 2021, pembrolizumab was approved for use in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1 to 5 cm above the gastroesophageal junction) carcinoma who...

kidney cancer

Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma

On March 10, 2021, the VEGF tyrosine kinase inhibitor tivozanib was approved for treatment of adults with relapsed or refractory advanced renal cell carcinoma following at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on findings in the open-label, phase III...

lymphoma
immunotherapy

Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma

On March 5, 2021, the CD19-directed genetically modified autologous T-cell immunotherapy axicabtagene ciloleucel was granted accelerated approval for treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1,2 Axicabtagene ciloleucel is...

sarcoma
immunotherapy

Addition of Prime-Boost Vaccination Regimen to Atezolizumab in Soft-Tissue Sarcomas Expressing NY-ESO-1

In a phase II trial reported in the Journal of Clinical Oncology, Sant P. Chawla, MD, and colleagues found that the addition of the heterologous prime-boost vaccination regimen CMB305 to atezolizumab did not improve survival outcomes in patients with soft-tissue sarcomas expressing the...

gastrointestinal cancer

KIT Inhibitor Combination Shows Efficacy in Refractory GIST

In a phase Ib/IIa trial reported in JAMA Oncology, Wagner et al found that the combination of a type I KIT inhibitor, PLX9486, with the type II inhibitor sunitinib produced clinical benefit and improved progression-free survival rates in patients with refractory gastrointestinal stromal tumors...

prostate cancer

Expert Point of View: Mary-Ellen Taplin, MD

Invited discussant of the VISION trial, Mary-Ellen Taplin, MD, of Dana-Farber Cancer Institute, Boston, commented on the study, noting that she was a co-investigator of the trial. “Patients with metastatic castration-resistant prostate cancer have a number of treatment options. There are 10...

Conquer Cancer, the ASCO Foundation, Awards More Than $10 Million to Support Cancer Research

Conquer Cancer, the ASCO Foundation, is pleased to announce the recipients of its awards supporting researchers with projects spanning across many areas in cancer care, including immunotherapy, precision medicine, breast cancer, and palliative care. This year, Conquer Cancer is funding the largest...

lung cancer
genomics/genetics
immunotherapy

Amivantamab/Lazertinib Combination May Overcome Osimertinib Resistance in Patients With EGFR-Positive NSCLC

Combination targeting of epidermal growth factor receptor (EGFR) with amivantamab/lazertinib achieved durable responses in more than one-third of chemotherapy-naive patients with EGFR-mutant non–small cell lung cancer (NSCLC) that had progressed on osimertinib, according to a cohort analysis of the ...

prostate cancer

Reducing Prostate Cancer Disparity by Bringing Care to Underserved Populations

The dire cancer incidence and mortality statistics for Black patients compared with White patients are well known. Collectively, Black individuals have the highest mortality rate and shortest survival of any racial or ethnic group in the United States for most cancers. Black men also have the...

skin cancer
immunotherapy

Responses to Pembrolizumab and Ipilimumab After Anti–PD-1/L1 Failure in Advanced Melanoma

Despite new and effective treatments for melanoma with checkpoint inhibitors and targeted therapies, patients with metastatic melanoma who progress on frontline treatment generally do very poorly. “We really need to make sure we give these patients access to drugs that we know have some efficacy,”...

Assessment of Targeted Methylation-Based Multicancer Early Detection Test in Independent Validation Cohort

In a validation study reported in Annals of Oncology, Klein et al found that a targeted methylation-based multicancer early detection (MCED) assay using cell-free DNA (cfDNA) sequencing had high specificity for cancer signal detection and high accuracy in predicting cancer signal origin across a...

lung cancer

Sotorasib: Subgroup Analysis of Phase II Trial Shows Activity With Breakthrough KRAS Inhibitor in Lung Cancer

The breakthrough KRAS-specific inhibitor sotorasib achieved responses in patients with KRAS G12C–mutated non–small lung cancer (NSCLC) who had experienced disease progression on platinum-based chemotherapy, immunotherapy, or both treatments. The objective response rate was 37.1%, and responses...

multiple myeloma

Overall Survival With the Addition of Ixazomib to Lenalidomide/Dexamethasone in Relapsed or Refractory Multiple Myeloma

As reported in the Journal of Clinical Oncology by Paul G. Richardson, MD, and colleagues, the final overall survival analysis of the phase III TOURMALINE-MM1 trial showed no overall survival benefit with the addition of ixazomib to lenalidomide/dexamethasone (Rd) in relapsed or refractory multiple ...

lung cancer

Trilaciclib to Reduce Chemotherapy-Induced Bone Marrow Suppression in Extensive-Stage Small Cell Lung Cancer

On February 12, 2021, the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor trilaciclib was approved for use to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide–containing regimen or topotecan-containing regimen for...

breast cancer
immunotherapy

Noninvasive Imaging Biomarker and Pathologic Complete Response to Neoadjuvant Pertuzumab/Trastuzumab in HER2-Positive Breast Cancer

As reported in the Journal of Clinical Oncology by Roisin M. Connolly, MD, and colleagues, updated results of the phase II TBCRC026 trial indicate an association of early F-18 fluorodeoxyglucose positron-emission tomography/computed tomography (F-18 FDG PET/CT) maximum standardized uptake value...

hepatobiliary cancer
genomics/genetics

FDA Grants Accelerated Approval to Infigratinib for Metastatic Cholangiocarcinoma With an FGFR2 Fusion or Rearrangement

On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor infigratinib (Truseltiq) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or ...

lymphoma
immunotherapy

Lisocabtagene Maraleucel for Relapsed or Refractory Large B-Cell Lymphoma

On February 5, 2021, lisocabtagene maraleucel was approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from...

ASCO Honors 2021 Special Awards Recipients

Researchers, patient advocates, and global oncology leaders who have worked to reshape cancer care around the world are among the recipients of ASCO’s Special Awards—the Society’s highest honors—and the Women Who Conquer Cancer Mentorship Awards from Conquer Cancer, the ASCO Foundation. “The...

lymphoma

Pembrolizumab Improves Progression-Free Survival vs Brentuximab Vedotin in Relapsed or Refractory Classic Hodgkin Lymphoma

As reported in The Lancet Oncology by John Kuruvilla, MD, of Princess Margaret Cancer Centre, Toronto, and colleagues, an interim analysis of the phase III KEYNOTE-204 trial has shown significantly improved progression-free survival with pembrolizumab vs brentuximab vedotin in patients with...

thyroid cancer

Receptor Tyrosine Kinase Inhibitor Lenvatinib for Anaplastic Thyroid Cancer

As reported in the Journal of Clinical Oncology by Lori J. Wirth, MD, and colleagues, a phase II trial of lenvatinib in patients with anaplastic thyroid cancer was stopped for futility after an interim analysis. Study Details In the international multicenter trial, 34 patients received lenvatinib...

bladder cancer
immunotherapy

Sacituzumab Govitecan-hziy for Patients With Pretreated Metastatic Urothelial Carcinoma

In a cohort of the phase II TROPHY-U-01 trial reported in the Journal of Clinical Oncology, Scott T. Tagawa, MD, MS, and colleagues found that the antibody-drug conjugate sacituzumab govitecan-hziy produced responses in patients with metastatic urothelial carcinoma progressing after platinum-based...

skin cancer

Lifileucel for Patients With Previously Treated Metastatic Melanoma

In a cohort of a phase II study reported in the Journal of Clinical Oncology, Amod A. Sarnaik, MD, and colleagues found that the tumor-infiltrating lymphocyte therapy lifileucel produced durable responses in patients with metastatic melanoma previously treated with checkpoint inhibitors and BRAF-...

covid-19

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents

On May 10, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents aged 12 through 15. The FDA...

lung cancer
immunotherapy

Cemiplimab-rwlc for First-Line Treatment of NSCLC With High PD-L1 Expression

On February 22, 2021, cemiplimab-rwlc was approved for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC; locally advanced who are not candidates for surgical resection or definitive chemoradiation therapy or metastatic) whose tumors have high PD-L1 expression (tumor...

lung cancer
immunotherapy

Five-Year Efficacy Outcomes With Pembrolizumab vs Chemotherapy in Metastatic NSCLC With PD-L1 Tumor Proportion Score of at Least 50%

As reported by Martin Reck, MD, PhD, and colleagues in the Journal of Clinical Oncology, the 5-year follow-up of the pivotal phase III KEYNOTE-024 trial shows maintained overall survival benefit in patients treated with pembrolizumab vs chemotherapy—despite substantial crossover to the...

global cancer care

Incidence and Cancer-Related Mortality in Belize

Located on the northeast coast of Central America, Belize is a small, upper middle–income country bordered by Mexico, Guatemala, and the Caribbean Sea. Belize has a population of about 405,000 people (Table 1), of which about 15% are immigrants. Belize is considered to be one of the most...

lymphoma

Umbralisib for Previously Treated Relapsed or Refractory Marginal Zone Lymphoma and Follicular Lymphoma

On February 5, 2021, umbralisib was granted accelerated approval for the following indications: adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti–CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have...

skin cancer
immunotherapy

Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma

On February 9, 2021, cemiplimab-rwlc was granted regular approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who were previously treated with a Hedgehog pathway inhibitor or for whom this type of therapy is not appropriate and granted accelerated approval for...

prostate cancer
genomics/genetics

Effect of Genomic Prostate Score Testing on Choice of Active Surveillance in a Predominantly Black Patient Population

In the ENACT study, reported in the Journal of Clinical Oncology, Murphy et al found that use of the 12-gene Genomic Prostate Score (GPS) in a predominantly Black patient population with relatively low-risk prostate cancer tended to be associated with reduced selection of active...

skin cancer

Unselected Autologous Tumor-Infiltrating Lymphocyte Therapy for Metastatic Cutaneous Melanoma

Treatment with unselected autologous tumor-infiltrating lymphocytes (TILs) showed early clinical efficacy among patients with advanced melanoma, according to results presented by Hawkins et al during week 1 of the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 (Abstract ...

kidney cancer

KEYNOTE-427: First-Line Pembrolizumab Shows Activity in Advanced Clear Cell and Non–Clear Cell Kidney Cancers

As reported in two articles in the Journal of Clinical Oncology by David F. McDermott, MD, of Beth Israel Deaconess Medical Center, and colleagues, the phase II KEYNOTE-427 study showed that pembrolizumab monotherapy produced durable responses as first-line treatment in cohorts of patients with...

lymphoma
immunotherapy

Pembrolizumab vs Brentuximab Vedotin in Relapsed or Refractory Classical Hodgkin Lymphoma: KEYNOTE-204 Trial

As reported in The Lancet Oncology by John Kuruvilla, MD, and colleagues, an interim analysis of the phase III KEYNOTE-204 trial has shown significantly improved progression-free survival with pembrolizumab vs brentuximab vedotin in patients with relapsed or refractory classical Hodgkin lymphoma....

kidney cancer
immunotherapy

Nivolumab Plus Cabozantinib as First-Line Treatment of Advanced Renal Cell Carcinoma

On January 22, 2021, the U.S. Food and Drug Administration approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma.1-3 Supporting Efficacy Data Approval was based on the findings of the phase III, open-label CheckMate 9ER trial...

gynecologic cancers
covid-19

Brian M. Slomovitz, MD, on the Impact of COVID-19 on Gynecologic Cancer Research

Brian M. Slomovitz, MD, of Florida International University, describes how emphasizing diversity and shifting away from clinical trials at universities helped The GOG Foundation, Inc., increase patient accrual by 50% in 2020 (ID # 10215).

lymphoma

Crizotinib for Children and Young Adults With Relapsed or Refractory Systemic ALK-Positive Anaplastic Large Cell Lymphoma

On January 14, 2021, crizotinib was approved for treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.1,2 The safety and efficacy of crizotinib have not been established in older...

lung cancer

Tepotinib for Metastatic NSCLC With MET Exon 14–Skipping Alterations

On February 3, 2021, tepotinib was granted accelerated approval for treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14–skipping alterations.1,2 Supporting Efficacy Data Approval was supported by findings from the...

covid-19

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

On February 27, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of COVID-19. The EUA allows the Janssen COVID-19 Vaccine to be distributed in the United States for use in individuals 18 years of age and older. The FDA...

kidney cancer
immunotherapy

KEYNOTE-427: First-Line Pembrolizumab in Advanced Non–Clear Cell Renal Cell Carcinoma

As reported in the Journal of Clinical Oncology by McDermott et al, findings in a cohort of the phase II KEYNOTE-427 study showed that pembrolizumab monotherapy produced durable responses as first-line treatment for advanced non–clear cell renal cell carcinoma. In a separate cohort of the study,...

hematologic malignancies

In Case You Missed It: Brief Highlights From ASH 2020

In case you missed these while attending the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, below is a sampler of highlights that were not included in our first round of meeting coverage. Many of these reports are on early-phase clinical trials of agents that may raise...

global cancer care

Cancer on the Global Stage: Incidence and Cancer-Related Mortality in Kenya

The ASCO Post is pleased to continue this occasional special focus on the worldwide cancer burden. In this issue, we feature a close look at the cancer incidence and mortality rates in Kenya. The aim of this special feature is to highlight the global cancer burden for various countries of the...

kidney cancer
immunotherapy

KEYNOTE-427: First-Line Pembrolizumab in Advanced Clear Cell Renal Cell Carcinoma

As reported in the Journal of Clinical Oncology by McDermott et al, findings in a cohort of the phase II KEYNOTE-427 study showed that pembrolizumab monotherapy produced durable responses as first-line treatment for advanced clear cell renal cell carcinoma. In a separate cohort of the study,...

lung cancer
immunotherapy

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...

breast cancer

Elacestrant for Heavily Pretreated Patients With ER-Positive, HER2-Negative Metastatic Breast Cancer

In a phase I trial reported in the Journal of Clinical Oncology, Aditya Bardia, MD, MPH, and colleagues identified activity of the oral selective estrogen receptor (ER) degrader (SERD) elacestrant in postmenopausal women with heavily pretreated ER-positive, HER2-negative breast cancer, including...

covid-19

FDA Update: Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate, Statement on Product Development to Address Virus Variants

On February 4, the U.S. Food and Drug Administration (FDA) announced the scheduling of a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss the request for emergency use authorization for a COVID-19 vaccine from Janssen Biotech Inc. Additionally, Acting...

colorectal cancer
covid-19
issues in oncology

Socially Distant Drive-by FluFIT Clinics May Increase Colorectal Cancer Screening Rates Among Black Patients During the COVID-19 Pandemic

Administering colorectal cancer screening kits through a socially distant drive-by flu vaccination clinic increased access to colorectal cancer screening among Black Americans, according to results presented by Washington et al at the AACR Virtual Meeting: COVID-19 and Cancer (Abstract S02-04)....

breast cancer
immunotherapy

Margetuximab-cmkb vs Trastuzumab in Heavily Pretreated Patients With HER2-Positive Breast Cancer: SOPHIA Trial

As reported in JAMA Oncology by Hope S. Rugo, MD, and colleagues, the phase III SOPHIA trial has shown significantly prolonged progression-free survival with margetuximab-cmkb plus chemotherapy vs trastuzumab plus chemotherapy in patients with HER2-positive breast cancer who experienced disease...

Winners of 40 Under 40 in Cancer Awards Announced

40 Under 40 in cancer is an awards initiative to identify and recognize contributions from across the field of oncology by approximately rising stars and emerging leaders younger than 40. Awardees were nominated by colleagues and selected by a panel of reviewers from a range of areas in oncology....

Expert Point of View: Yuan Yuan, MD, PhD, and Elizabeth Mittendorf, MD, PhD

Yuan Yuan, MD, PhD, a medical oncologist at City of Hope, Duarte, California, weighed in on the KEYNOTE-355 findings. “The study presented by Dr. Rugo on KEYNOTE-355 reconfirms the utility of adding immune checkpoint inhibitorsto chemotherapy as front-line treatment for metastatic triple-negative...

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