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Showing 1301 - 1350KEYNOTE-564 Update Supports Benefit of Adjuvant Pembrolizumab in High-Risk Renal Cell Carcinoma
An updated analysis of the phase III KEYNOTE-564 trial continues to support the use of adjuvant pembrolizumab vs placebo in patients with renal cell carcinoma at high risk of recurrence, according to a presentation at the 2022 ASCO Genitourinary Cancers Symposium.1 At 30 months of follow-up,...
Importing Oncology Trials From China, or Other Single Foreign Countries, for Consideration of U.S. Regulatory Approvals
In a commentary published recently in The Lancet Oncology,1 Harpreet Singh, MD, and Richard Pazdur, MD, both of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA), warned against the increasing number of oncology drug development programs based wholly or predominantly...
Project Confirm: An Initiative to Promote Transparency of the Accelerated Approval Program for Oncology Indications
OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Gautam U. Mehta, MD, Neurosurgical Oncologist and Clinical Reviewer, Division of Oncology 2; Fatima Rizvi,...
Time for a Radical Change in the Treatment of Endometrial Cancer: KEYNOTE-775 and Beyond
I had the privilege of sitting in a meeting on the treatment of endometrial cancer as a junior investigator in January 2015 where a representative from the U.S. Food and Drug Administration was present. The topic of the meeting was on how to design the next endometrial cancer trials. I remember...
Clinical Trials Underway for T-DXd in Breast Cancer
The current standard of care for the neoadjuvant treatment of HER2-positive early-stage breast cancer consists of trastuzumab plus pertuzumab and polychemotherapy. But some patients, particularly those with locally advanced or inflammatory disease, still relapse and die. Furthermore, multiagent...
Combinations Advance the Power of Pembrolizumab in Hodgkin Lymphoma
Pembrolizumab monotherapy is an established treatment strategy for relapsed or refractory classical Hodgkin lymphoma. In combination with chemotherapy, the checkpoint inhibitor is also showing value in the front-line setting and further boosting outcomes in the relapsed setting, according to...
Checkpoint Inhibitors in Esophagogastric Cancer: Updates of Landmark Trials
Updates of landmark trials of immune checkpoint inhibitors as first-line therapy for advanced HER2-negative esophagogastric cancers were presented at the 2022 ASCO Gastrointestinal Cancers Symposium. The studies upheld previous findings of an overall survival benefit when these agents are paired...
Small Study Reports Neoadjuvant PD-1 Blockade Yields 100% Clinical Complete Response Rate in Locally Advanced Mismatch Repair–Deficient Rectal Cancer
In a small study of patients with locally advanced mismatch repair–deficient (dMMR) rectal cancer, treatment with the anti–PD-1 agent dostarlimab-gxly alone led to a clinical complete response rate of 100%. The findings of this study from Memorial Sloan Kettering Cancer Center (MSK) were reported...
Massage for Pain Management in the Cancer Population
Guest Editor’s Note: Pain is a debilitating symptom experienced by many patients with cancer that negatively impacts their quality of life. Massage therapy, historically used for relaxation and pain relief, plays an important supportive role in oncology settings. In this installment of The ASCO...
Robust and Durable Responses to Pembrolizumab in Patients With Previously Treated MSI-H/dMMR Endometrial Cancer
“Robust and clinically meaningfulantitumor activity,” with durable responses and “encouraging survival outcomes,” were reported among patients with previously treated microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) endometrial tumors who received pembrolizumab in the...
CAR T-Cell Therapy as Second-Line Treatment in Large B-Cell Lymphomas
“The mind is not a vessel to be filled but a fire to be kindled.” —Plutarch About 30% to 40% of patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) experience relapse, and 10% are refractory to the...
Updated Findings on T-DXd in Gastrointestinal Malignancies
Updates of phase II studies evaluating fam-trastuzumab deruxtecan-nxki (T-DXd) in gastrointestinal cancers were presented at the 2022 ASCO Gastrointestinal Cancers Symposium, continuing to offer support for the antibody-drug conjugate in these malignancies. In HER2-expressing gastric cancer, T-DXd...
Risk of Major Adverse Cardiovascular Events With Combined Immune Checkpoint Inhibition and VEGFR Inhibition in Patients With Advanced RCC
As reported in the Journal of Clinical Oncology by Brian I. Rini, MD, and colleagues, prospective cardiovascular monitoring in the phase III JAVELIN Renal 101 trial in advanced renal cell carcinoma (RCC) showed that patients with higher baseline troponin T levels receiving the combination of the...
FDA Approves Neoadjuvant Nivolumab and Platinum Doublet Chemotherapy for Early-Stage NSCLC
On March 4, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with platinum-doublet chemotherapy for adult patients with resectable non–small cell lung cancer (NSCLC) in the neoadjuvant setting. This represents the first FDA approval for neoadjuvant therapy for...
Esophagus-Sparing vs Standard Palliative Radiation for Patients With Advanced Central NSCLC
As reported in JAMA Oncology by Louie et al, the Canadian phase III PROACTIVE trial showed that esophagus-sparing intensity-modulated radiotherapy (ES-IMRT) did not significantly improve esophageal quality of life vs standard radiotherapy in patients with advanced central non–small cell lung cancer ...
Expert Point of View: Amy Tiersten, MD, and Carlos L. Arteaga, MD
Amy Tiersten, MD, Professor of Medicine, Hematology, and Medical Oncology, Icahn School of Medicine at Mount Sinai, and Carlos L. Arteaga, MD, Director of the Simmons Comprehensive Cancer Center and Associate Dean of Oncology at The University of Texas Southwestern Medical Center, Dallas,...
PADA-1 Trial: With Early Identification of ESR1 Mutation, Switch to Fulvestrant in Metastatic Breast Cancer
Switching from an aromatase inhibitor to fulvestrant upon early identification of the ESR1 mutation in plasma—before disease progression—doubled progression-free survival in the phase III PADA-1 trial, presented at the 2021 San Antonio Breast Cancer Symposium.1 “PADA-1 is the first trial to...
EMERALD Trial: Oral Selective Estrogen Receptor Degrader as Second- or Third-Line Therapy for Advanced Breast Cancer
Use of the first investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly reduced the risk of death or disease progression and lengthened progression-free survival compared with standard-of-care endocrine therapy with fulvestrant or an aromatase inhibitor in...
Metformin Added to Standard Adjuvant Chemotherapy Fails to Improve Outcomes in Early Breast Cancer
The addition of metformin, a drug commonly used to treat type 2 diabetes, to standard adjuvant treatment failed to improve invasive disease–free survival or overall survival for hormone receptor–positive or –negative breast cancer, according to the results of a large landmark trial led by the...
Expert Point of View: Matthew J. Ellis, MB, BChir, PhD, FACP
The final results of the phase III PALLAS trial1 are “deeply disappointing,” said session moderator Matthew J. Ellis, MB, BChir, PhD, FACP, Professor of Medicine and Director of the Lester and Sue Smith Breast Center at Baylor College of Medicine. The results of the final primary analysis of...
Final Analysis of PALLAS Trial: No Benefit of Adjuvant Palbociclib Plus Endocrine Therapy in Early Breast Cancer
The final protocol-defined analysis of the phase III PALLAS trial confirmed the negative results of the second interim analysis, showing no benefit of palbociclib plus endocrine therapy in the adjuvant breast cancer setting. Michael Gnant, MD, of the Medical University of Vienna, reported these...
Evidence Supports Ovarian Function Suppression Plus Aromatase Inhibitor in Premenopausal Women With Early Breast Cancer
The benefits of ovarian function suppression were sustained long term for premenopausal women with hormone receptor–positive breast cancer, according to updates from SOFT and TEXT, two randomized, controlled trials, presented at the 2021 San Antonio Breast Cancer Symposium.1 A separate large...
MONALEESA Analyses Show Widespread Benefit for Ribociclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
Further analyses of the MONALEESA metastatic breast cancer trials have shown that the benefit of ribociclib plus endocrine therapy in the first-line setting extends to most intrinsic molecular subtypes and is consistent across multiple subgroups. The studies were presented at the 2021 San Antonio...
Expert Point of View: Anne Blaes, MD, MS, and Virginia Kaklamani, MD
Commenting on the update of RxPONDER presented at the 2021 San Antonio Breast Cancer Symposium were Anne Blaes, MD, MS, Associate Professor of Hematology/Oncology at the University of Minnesota and Co-Director of the Screening, Prevention, Etiology and Cancer Survivorship Program at the Masonic...
RxPONDER Update Explores Benefit of Chemotherapy in Subgroups
Updated results of the SWOG S1007 RxPONDER trial confirmed the key takeaway from the previous analysis: adjuvant chemotherapy benefits premenopausal women but not postmenopausal women with hormone receptor–positive, HER2-negative disease, one to three positive lymph nodes, and a 21-gene Oncotype DX ...
Identifying Women With Triple-Negative Breast Cancer Who May Benefit From Pembrolizumab Plus Chemotherapy
Results of the phase III randomized KEYNOTE-355 trial showed that the addition of the PD-1 inhibitor pembrolizumab to investigator’s choice of first-line chemotherapy improved progression-free and overall survival in women with metastatic triple-negative breast cancer compared with placebo and...
Expert Point of View: Hope S. Rugo, MD, FASCO
The discussant of KEYNOTE-522 at the 2021 San Antonio Breast Cancer Symposium, Hope S. Rugo, MD, FASCO, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center, commented: “We are clearly making...
KEYNOTE-522: Sensitivity Analyses Confirm Value of Neoadjuvant Pembrolizumab in Triple-Negative Breast Cancer
Updated results from the pivotal KEYNOTE-522 trial have confirmed the benefit of neoadjuvant therapy with pembrolizumab plus chemotherapy in patients with early triple-negative breast cancer.1 The results were presented at the 2021 San Antonio Breast Cancer Symposium by Peter Schmid, MD, PhD,...
Clinical Trials Underway for T-DXd in Breast Cancer
The current standard of care for the neoadjuvant treatment of HER2-positive early-stage breast cancer consists of trastuzumab plus pertuzumab and polychemotherapy. But some patients, particularly those with locally advanced or inflammatory disease, still relapse and die. Furthermore, multiagent...
Second-Line T-DXd Improves Progression-Free Survival Across HER2-Positive Metastatic Breast Cancer Subgroups
The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) lengthened progression-free survival and improved the objective response rate compared with the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) after trastuzumab and taxane therapy in women with HER2-positive metastatic...
Highlights From the 2021 San Antonio Breast Cancer Symposium
In its first return to a hybrid model since the COVID-19 pandemic began, the 2021 San Antonio Breast Cancer Symposium (SABCS) brought together researchers, clinicians, industry experts, patients, and advocates from across the globe to present and grapple with new data and important topics in breast ...
Isatuximab-Containing Induction Therapy for Multiple Myeloma Increases Measurable Residual Disease Negativity
For the first-line treatment of newly diagnosed multiple myeloma, the percentage of patients achieving measurable residual disease (MRD, previously called minimal residual disease) negativity was significantly greater when the anti-CD38 monoclonal antibody isatuximab was added to a standard...
Studies Evaluate Screening for Early Multiple Myeloma
Precursors to multiple myeloma were identified by population screening in two studies reported at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition. The prevalence of monoclonal gammopathies was determined in the PROMISE trial using cutting-edge technology in a high-risk ...
PANTHER: No Significant Benefit for Pevonedistat Plus Azacitidine in Higher-Risk Myelodysplastic Syndrome
The phase III PANTHER trial, which evaluated pevonedistat plus azacitidine vs azacitidine alone in higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia, and low–blast count acute myeloid leukemia (AML) failed to meet its primary endpoint of event-free survival,1 though lessons...
Mosunetuzumab Meets Primary Endpoint of Phase II Trial in Relapsed or Refractory Follicular Lymphoma
The bispecific antibody mosunetuzumab achieved deep and durable remissions as monotherapy in patients with relapsed or refractory follicular lymphoma, according to the results of a pivotal phase II trial presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition.1 In ...
ZUMA-7: Axicabtagene Ciloleucel Quadruples Event-Free Survival in Large B-Cell Lymphoma
In the primary analysis of the phase III ZUMA-7 trial, examining second-line therapy for relapsed or refractory large B-cell lymphoma, the CAR T-cell therapy axicabtagene ciloleucel led to a fourfold increase in event-free survival over the standard of care. These findings were presented at the...
POLARIX: Addition of Polatuzumab Vedotin-piiq to Standard of Care Significantly Reduces Progression of Diffuse Large B-Cell Lymphoma
As a first-line treatment of intermediate- or high-risk diffuse large B-cell lymphoma, the addition of the antibody-drug conjugate polatuzumab vedotin-piiq to standard-of-care therapy resulted in a 27% reduction in the relative risk of disease progression, relapse, or death, with a similar safety...
Single-Cell Spatial Connectivity Analysis Offers ‘Unprecedented’ Information in Breast Cancer
A next-generation technology that focuses on protein expression at the single-cell level has yielded a wealth of information about “spatial connectivity” between cancer cells and their microenvironment. It also provided information on the benefit of adding the immune checkpoint inhibitor...
Improved Outcomes With Time-Limited Venetoclax Combinations vs Chemoimmunotherapy in Fit Patients With CLL
Administering time-limitedcombination regimens of venetoclax plus obinutuzumab or venetoclax plus obinutuzumab and ibrutinib was superior to chemoimmunotherapy in achieving undetectable measurable residual disease (MRD) in the peripheral blood at month 15 in fit patients with chronic lymphocytic...
In Case You Missed It: Brief Highlights From the 2021 ASH Annual Meeting & Exposition
COVID has upended our world, and medical conferences have had to adapt to ever-shifting sands depending on the behavior of the variants of the virus that emerge. The 2021 American Society of Hematology (ASH) Annual Meeting & Exposition was no exception, offering a hybrid meeting for in-person...
PARP Inhibitor Plus Abiraterone Benefits Subgroups of Patients With Metastatic Castration-Resistant Prostate Cancer
The combination of the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib plus abiraterone acetate and prednisone as first-line therapy significantly improved radiographic progression-free survival vs abiraterone and placebo alone in men with metastatic castration-resistant prostate cancer...
Similar Efficacy but Better Tolerability for Ripretinib vs Sunitinib in Second-Line GIST Therapy
In the INTRIGUE trial, reported during the January 2022 session of the virtual ASCO Plenary Series, the tyrosine kinase inhibitor ripretinib was not superior to sunitinib in the second-line treatment of patients with advanced gastrointestinal stromal tumors (GIST) but was better tolerated.1...
BELINDA: CAR T-Cell Therapy Fails to Improve Outcomes in Aggressive Non-Hodgkin Lymphoma
The autologous chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel failed to improve event-free survival vs standard-of-care treatment strategies in patients with aggressive, relapsed or refractory non-Hodgkin lymphoma (NHL), according to the results of the phase III BELINDA trial,...
AGILE: Addition of Ivosidenib to Azacitidine Triples Median Overall Survival in Difficult-to-Treat AML Population
In patients with newly diagnosed acute myeloid leukemia (AML) with an IDH1 mutation who were ineligible for intensive chemotherapy, the addition of the IDH1 inhibitor ivosidenib to azacitidine significantly improved survival vs azacitidine alone, according to data presented at the 2021 American...
Fixed-Duration Venetoclax Plus Ibrutinib Achieves Deep and Durable MRD Remissions in CLL
Two different trials presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition found that fixed-duration treatment with ibrutinib and venetoclax achieved deep and sustained undetectable measurable residual disease (MRD) status when used as first-line therapy for...
Study Examines Predictive Biomarker for Bladder Cancer Survival
Long-term survival data from the first prospective, randomized biomarker validation trial in patients with muscle-invasive bladder cancer being treated with cisplatin-based chemotherapy before surgery are being reported at the 2022 ASCO Genitourinary Cancers Symposium by Thomas W. Flaig, MD, and...
Improved Outcomes With Time-Limited Venetoclax Combinations vs Chemoimmunotherapy in Fit Patients with CLL
Administering time-limited regimens that were combinations of venetoclax plus obinutuzumab or venetoclax plus obinutuzumab and ibrutinib was superior to chemoimmunotherapy in achieving undetectable measurable residual disease in the peripheral blood at month 15 in fit patients with chronic...
Highlights From the 2021 ASH Annual Meeting & Exposition
The ongoing COVID-19 pandemic and successful hybrid format dominated much of the discussion at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, but the lasting impact of the meeting will be the groundbreaking research that was presented. Throughout all diseases,...
Does Daily Aspirin Help Prevent Breast Cancer Recurrence?
Taking aspirin daily does not prevent breast cancer recurrence, according to research presented by Wendy Y. Chen, MD, MPH, a medical oncologist at Dana-Farber Cancer Institute, during the February 2022 ASCO Plenary Series session (Abstract 360922). Results of a double-blind phase III study of more...
KRAS G12C Inhibitor Sotorasib Shows Activity in Certain Patients With Pancreatic Cancer
Sotorasib, an irreversible inhibitor of KRAS G12C, showed activity in patients with metastatic pancreatic cancer and a KRAS G21C mutation enrolled in the phase I/II CodeBreaK100 study. These findings were presented during the February 2022 ASCO Plenary Series session by John H. Strickler, MD,...
