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Showing 3001 - 3050PRIME Trial: Niraparib Maintenance Therapy Improves Progression-Free Survival in Advanced Ovarian Cancer
A larger population of patients with newly diagnosed advanced ovarian cancer may be able to benefit from niraparib maintenance therapy, with an improved safety profile, according to phase III data presented at the 2022 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer.1 Results ...
Updated Overall Survival Results From MONALEESA-3 Show Improved Overall Survival in Patients With HR-Positive/HER2-Negative Breast Cancer
In an updated analysis of the phase III MONALEESA-3 trial, which included postmenopausal patients with advanced/metastatic hormone receptor (HR)-positive, HER2-negative breast cancer, first-line treatment with ribociclib plus fulvestrant lengthened overall survival by approximately 16 months vs...
TUXEDO-1: Efficacy of T-DXd for Patients With HER2-Positive Breast Cancer and Active Brain Metastases
In the single-center phase II TUXEDO-1 trial of patients with advanced HER2-positive breast cancer, fam-trastuzumab-deruxtecan-nxki (T-DXd) showed efficacy in patients with active brain metastases, yielding intracranial responses in 73.3% of the population and a median progression-free survival of...
Absence of FAM19A4/miR124-2 DNA Methylation and Clinical Regression of High-Grade Cervical Intraepithelial Neoplasia
In the Dutch CONCERVE study reported in the Journal of Clinical Oncology, Kremer et al found that the absence of FAM19A4/miR124-2 DNA methylation was associated with a high rate of clinical regression of high-grade cervical intraepithelial neoplasia over 24 months among women treated with a...
Neoadjuvant Nivolumab and Platinum-Doublet Chemotherapy for Early NSCLC
On March 4, 2022, nivolumab was approved for use with platinum-doublet chemotherapy for resectable non–small cell lung cancer (NSCLC) in the neoadjuvant setting.1 The approval is the first for neoadjuvant therapy for early-stage NSCLC. Supporting Efficacy Data Approval was based on findings from...
AACR Honors Lee Ellis, MD, for Contributions to Education and Training in Cancer Research
The American Association for Cancer Research (AACR) has named Lee Ellis, MD, Professor of Colon and Rectal Surgery at The University of Texas MD Anderson Cancer Center, Houston, as the 2022 recipient of the AACR Daniel D. Von Hoff Award for Outstanding Contributions to Education and Training in...
Natural Killer Cells Precomplexed With Innate Cell Engager Show Activity in CD30-Positive Lymphoma
Natural killer (NK) cells derived from donated umbilical cord blood, activated with a novel bispecific antibody targeting CD16A and CD30 known as AFM13, have yielded responses in patients with pretreated and refractory CD30-positive lymphoma. The overall response rate was 89%, with 53% complete...
Going the Last Mile: Accelerating Delivery of Multiple Myeloma Therapies to All Patients
When I was diagnosed with multiple myeloma in 1996, I was given 3 years to live. At the time, there was little understanding of this disease, which was termed incurable. There were no new treatments, few drugs in the pipeline, hardly any clinical trials, and no multiple myeloma community or...
Nivolumab and Salvage Nivolumab/Ipilimumab for Previously Untreated Advanced Clear Cell Renal Cell Carcinoma
In a phase II trial (Hoosier Cancer Research Network GU16-260) reported in the Journal of Clinical Oncology, Michael B. Atkins, MD, and colleagues found that nivolumab monotherapy was active in previously untreated patients with advanced clear cell renal carcinoma, particularly among those with...
2-Year Follow-up Shows Durable Responses With Sotorasib in KRAS G12C–Mutated Non–Small Cell Lung Cancer
Sotorasib, the first KRAS G12C inhibitor approved for the treatment of KRAS G12C–mutated non–small cell lung cancer (NSCLC), continues to demonstrate meaningful and durable efficacy at 2-year follow-up in the phase II CodeBreaK 100 trial. At a median follow-up of 24.9 months, the 2-year overall...
Hematologic Oncology 2021–2022 Almanac
Ongoing evaluation of novel, targeted, and immunotherapies has led to exciting advances across the array of hematologic malignancies over the past year. The availability of new treatment options, along with emerging data on novel combinations and sequencing approaches, is rapidly changing...
Bispecific Antibodies With Multiple Targets Moving Forward in Multiple Myeloma
Poor outcomes are observed in patients with myeloma who are refractory to multiple classes of therapies, with the average patient experiencing disease progression in up to 6 months and living no longer than 6 to 15 months. Patients often rapidly cycle through regimens that use less effective or...
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...
MAIA Trial: Daratumumab Added to Lenalidomide Plus Dexamethasone Improves Overall Survival in Transplant-Ineligible Multiple Myeloma
As reported in The Lancet Oncology by Thierry Facon, MD, of the Centre Hospitalier Universitaire de Lille, and colleagues, a prespecified interim analysis of overall survival in the pivotal phase III MAIA trial has shown a significant benefit with the addition of daratumumab to...
Maintenance Daratumumab Prolongs Progression-Free Survival in Newly Diagnosed Multiple Myeloma
As reported in The Lancet Oncology by Philippe Moreau, MD, of the University Hospital Hôtel-Dieu, Nantes, and colleagues, an interim analysis of part 2 of the phase III CASSIOPEIA trial has showed significantly prolonged progression-free survival with maintenance daratumumab vs observation...
Subcutaneous Daratumumab Added to Pomalidomide Plus Dexamethasone Improves Progression-Free Survival in Multiple Myeloma
As reported in The Lancet Oncology by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, and colleagues, the phase III APOLLO trial has shown significantly improved progression-free survival with the addition of subcutaneous (SC) daratumumab to oral...
BCMA-Directed CAR T-Cell Therapy Ciltacabtagene Autoleucel in Relapsed or Refractory Multiple Myeloma
In the phase Ib/II CARTITUDE-1 trial reported in The Lancet, Jesus G. Berdeja, MD, and colleagues found that ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell therapy with two B-cell maturation antigen (BCMA)-targeting single-domain antibodies, produced a high rate of...
Expert Point of View: Jane N. Winter, MD
Jane N. Winter, MD, moderator of the press conference on late-breaking abstracts at the 2021 American Society of Hematology (ASH) Annual Meeting & Exhibition, commented on the BELINDA study in the context of two investigations that had been previously reported at the same meeting, showing...
BELINDA Trial: 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 results of the phase III BELINDA trial,...
TRANSFORM: Lisocabtagene Maraleucel Improves Outcomes in Relapsed or Refractory Large B-Cell Lymphoma
Chimeric antigen receptor (CAR) T-cell therapy with lisocabtagene maraleucel could prove to be the new standard-of-care treatment for patients with relapsed or refractory large B-cell lymphoma in the second-line setting, according to data presented at the 2021 American Society of Hematology (ASH)...
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 ...
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 inter-mediate- 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...
Expert Point of View: Laurie H. Sehn, MD, MPH and Alex Herrera, MD
Laurie H. Sehn, MD, MPH, Clinical Professor with the BC Cancer Centre for Lymphoid Cancer and University of British Columbia, Vancouver, Canada, and Alex Herrera, MD, Associate Professor in Hematology and Hematopoietic Cell Transplantation at the Beckman Research Institute of City of Hope,...
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...
Dual PI3Kδ/CK1ε Inhibitor Umbralisib in Relapsed or Refractory Indolent Non-Hodgkin Lymphoma
As reported in the Journal of Clinical Oncology by Nathan H. Fowler, MD, of The University of Texas MD Anderson Cancer Center, and colleagues, a phase IIb trial (UNITY-NHL) has shown that the dual PI3Kδ/casein kinase (CK)1ε inhibitor umbralisib produced durable responses in patients with relapsed...
Addition of Copanlisib to Rituximab Improves Progression-Free Survival in Relapsed Indolent Non-Hodgkin Lymphoma
As reported in The Lancet Oncology by Matthew J. Matasar, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, the phase III CHRONOS-3 trial has shown that the addition of the pan-class I PI3K inhibitor copanlisib to rituximab significantly improved progression-free survival vs rituximab ...
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...
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...
Zanubrutinib Superior to Ibrutinib for CLL/SLL in Phase III ALPINE Trial
Zanubrutinib, a second-generation Bruton’s tyrosine kinase (BTK) inhibitor, significantly improved response rates and delayed disease progression as compared with the standard of care, ibrutinib, in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma...
ELEVATE-RR Trial: Acalabrutinib as Effective as Ibrutinib, With Fewer Cardiac Effects, in Resistant CLL
Acalabrutinib was equally efficacious with less toxicity when compared directly with ibrutinib in patients with previously treated relapsed or refractory chronic lymphocytic leukemia (CLL), according to the results of an open-label, randomized, noninferiority phase III trial presented at the 2021...
Deborah K. Armstrong, MD, on the Rationale for Intraperitoneal Treatment of Ovarian Cancer
Abstract discussant Deborah K. Armstrong, MD, of Johns Hopkins Kimmel Cancer Center Baltimore, elucidated the rationale for intraperitoneal (IP) treatment, which is the peritoneal pharmacokinetic advantage for many drugs used in ovarian cancer, including carboplatin, as used in the iPocc trial.1 In ...
Intraperitoneal Carboplatin Plus Paclitaxel vs Intravenous Chemotherapy in Ovarian Cancer
When compared with intravenous (IV) chemotherapy, the use of intraperitoneal (IP) carboplatin with dose-dense weekly paclitaxel improved progression-free survival in patients with ovarian, fallopian tube, or primary peritoneal carcinoma, according to data presented at the 2022 Society of...
Consolidation Durvalumab Alone or Combined With Oleclumab or Monalizumab for Unresectable Stage III NSCLC
In an interim analysis of the phase II COAST trial reported in the Journal of Clinical Oncology, Roy S. Herbst, MD, PhD, FACP, FASCO, and colleagues found that consolidation durvalumab in combination with the anti-CD73 antibody oleclumab or anti-NKG2A antibody monalizumab both improved objective...
Lenvatinib/Pembrolizumab vs Sunitinib in Patients With Advanced Renal Cell Carcinoma: Health-Related Quality-of-Life Outcomes
In a study reported in The Lancet Oncology, Robert Motzer, MD, and colleagues found that patients with previously untreated advanced renal cell carcinoma receiving lenvatinib/pembrolizumab had similar or favorable health-related quality of life scores and prolonged time to definitive deterioration...
FDA Grants Regular Approval to Fam-Trastuzumab Deruxtecan-nxki for Unresectable or Metastatic HER2-Positive Breast Cancer
On May 4, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu) for pretreated adult patients with unresectable or metastatic HER2-positive breast cancer. According to the approval, patients had to have received a prior anti-HER2–based regimen either in the...
SBRT Plus Nivolumab With or Without Ipilimumab in Refractory Metastatic Pancreatic Cancer
In the Danish single-institution phase II CheckPAC study reported in the Journal of Clinical Oncology, Chen et al found that the combination of nivolumab and ipilimumab plus stereotactic body radiotherapy (SBRT) improved the clinical benefit rate vs nivolumab plus SBRT in patients with refractory...
SWOG-1216: Orteronel vs Bicalutamide With ADT for Metastatic Hormone-Sensitive Prostate Cancer
As reported in the Journal of Clinical Oncology by Neeraj Agarwal, MD, and colleagues, the phase III SWOG-1216 trial showed no significant improvement in overall survival—the study’s primary endpoint—with orteronel plus androgen-deprivation therapy (ADT) vs bicalutamide plus ADT in patients with...
Cemiplimab-rwlc Improves Overall Survival vs Chemotherapy in Recurrent Cervical Cancer After First-Line Platinum-Based Chemotherapy
As reported in The New England Journal of Medicine by Krishnansu S. Tewari, MD, of the Division of Gynecologic Oncology, University of California, Irvine, and colleagues, the phase III EMPOWER-Cervical1/GOG-3016/ENGOT-cx9 trial has shown improved overall survival with cemiplimab-rwlc vs...
Demystifying Immunotherapy for Early-Stage Triple-Negative Breast Cancer
Immunotherapy has become a potential strategy in treating triple-negative breast cancer, though many questions remain to be answered before long-term survival is achieved by all patients. This exciting field of breast cancer research was explored at the 2022 Miami Breast Cancer Conference by...
Patient-Reported Outcomes and Toxicity With Adjuvant Stereotactic Pelvic Radiation Therapy in Uterine Cancers
In the Canadian phase I/II SPARTACUS study reported in JAMA Oncology, Leung et al found very low rates of severe genitourinary and gastrointestinal toxicity and worsening in only one patient-reported outcome domain among women receiving adjuvant stereotactic hypofractionated pelvic radiation...
Cancer Rates Declining in Canada, but Cases and Deaths Increasing Because of Demographic Factors
Overall cancer rates in Canada are declining, but the number of cases and deaths are increasing slightly because of population growth and an aging population, according to a new study published by Brenner et al in CMAJ (Canadian Medical Association Journal). The study is the result of a...
Addition of Ivosidenib to Azacitidine in Newly Diagnosed IDH1-Mutated Acute Myeloid Leukemia
In the phase III AGILE trial reported in The New England Journal of Medicine, Montesinos et al found that the addition of ivosidenib to azacitidine in induction therapy significantly prolonged event-free survival in patients with newly diagnosed IDH1-mutated acute myeloid leukemia. An overall...
Switch to Maintenance Endocrine Therapy Plus Bevacizumab After First-Line Paclitaxel/Bevacizumab Induction in Advanced Estrogen Receptor–Positive, HER2-Negative Breast Cancer
In the Japanese phase II BOOSTER trial reported in The Lancet Oncology, Saji et al found that compared with continuing paclitaxel/bevacizumab, a maintenance strategy of switching to endocrine therapy plus bevacizumab (with the option of reinitiating paclitaxel/bevacizumab) was associated with a...
Improved Long-Term Quality-of-Life Measures in Women Undergoing Breast Conservation vs Mastectomy and Reconstruction for Early Breast Cancer
In a study reported in JAMA Surgery, Hanson et al found no difference in long-term satisfaction with breasts among women with early breast cancer who underwent breast-conserving surgery with radiation therapy vs mastectomy and breast reconstruction without radiation therapy. Women who underwent...
How to Get the Dose Right
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, Mirat Shah, MD, of the Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA; Atiqur...
SORAYA Trial: Mirvetuximab Soravtansine Improves Response Rate in Drug-Resistant Ovarian Cancer
The novel antibody-drug conjugate mirvetuximab soravtansine could become the new standard of care for patients with folate receptor alpha–positive, platinum-resistant ovarian cancer, according to data presented at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting on Women’s Cancer.1...
Preoperative Radiotherapy and DIEP Flap Reconstruction in Women Requiring Mastectomy for Breast Cancer
In the PRADA study—reported by Thiruchelvam et al in The Lancet Oncology—researchers found that a strategy of preoperative radiotherapy and deep inferior epigastric perforator (DIEP) flap reconstruction was feasible and safe in women requiring mastectomy for breast cancer. As stated by the...
Navicixizumab Plus Paclitaxel in Platinum-Resistant Ovarian Cancer
In a phase Ib study reported in the Journal of Clinical Oncology, Fu et al found that the combination of navicixizumab (a bispecific antiangiogenic antibody to VEGF and delta-like ligand 4) and paclitaxel showed activity in patients with platinum-resistant ovarian cancer. Delta-like ligand 4 is a...
Narsoplimab for Hematopoietic Stem Cell Transplantation–Associated Thrombotic Microangiopathy
In a pivotal phase II trial reported in the Journal of Clinical Oncology, Samer K. Khaled, MD, and colleagues found that narsoplimab, an inhibitor of mannan-binding lectin-associated serine protease-2, showed efficacy in the treatment of adult patients with hematopoietic stem cell...
First-Line Therapy for BRCA2-Mutated Metastatic Castration-Resistant Prostate Cancer
This is Part 3 of Updates in Prostate Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Celestia (Tia) Higano, Julie Graff, and Neal Shore discuss the first-line therapy for BRCA2-mutated metastatic castration-resistant...
