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Showing 2401 - 2450FDA Pipeline: Advances in Prostate Cancer, Urothelial Cancer, Myelofibrosis, and More
In the past few weeks, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions in prostate cancer, urothelial cancer, myelofibrosis, breast cancer, pediatric brain cancer, leukemia, and skin cancer. Breakthrough Therapy Designation for Niraparib in Metastatic...
Durvalumab Plus Chemotherapy: New Option for Extensive-Stage SCLC
The addition of the immune checkpoint inhibitor durvalumab to standard therapy significantly improved overall survival vs standard therapy alone for patients with previously untreated extensive-stage small cell lung cancer (SCLC), according to a preplanned interim analysis of the phase III CASPIAN...
ESMO 2019: High Conversion Rate With Certain Induction Chemotherapy Regimens Is Associated With Improved Overall Survival in Locally Advanced Pancreatic Cancer
Induction chemotherapy with nab-paclitaxel plus gemcitabine or sequential FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, and irinotecan) followed by surgical exploration induced high conversion rates in patients with locally advanced pancreatic cancer, and conversion was associated with...
ESMO 2019: 3-Year Results From CheckMate 238: Adjuvant Nivolumab vs Ipilimumab in Advanced Melanoma
Superior recurrence-free survival benefit was observed with nivolumab vs ipilimumab—and was consistent across disease stage, programmed cell death ligand 1 (PD-L1) expression levels, and BRAF mutation status—in patients with resected stage III/IV melanoma and a high risk of recurrence, according to ...
ESMO 2019: Lenvatinib for Advanced Thymic Carcinoma
Patients with thymic carcinoma that has progressed following treatment with platinum-based chemotherapy may benefit from treatment with lenvatinib, according to findings from a phase II study reported by Itoh et al at the European Society for Medical Oncology (ESMO) Congress 2019 (Abstract ...
ESMO 2019: IMvigor130: Addition of Atezolizumab to Platinum-Based Chemotherapy in Advanced Urothelial Carcinoma
Patients with locally advanced or metastatic urothelial carcinoma demonstrated prolonged progression-free survival with the addition of atezolizumab to first-line platinum-based chemotherapy vs treatment with chemotherapy alone, according to phase III data from the IMvigor130 study presented by...
Studies Report Prolonged Long-Term Survival With Immunotherapy vs Chemotherapy in Advanced NSCLC
Longer-term follow-up of patients with advanced non–small cell lung cancer (NSCLC) who are treated with immunotherapy have appreciably extended survival at 5 years, suggesting that for some patients, this disease can be managed as a chronic condition. These findings are based on two presentations ...
ESMO 2019: BROCADE 3: Veliparib Plus Carboplatin/Paclitaxel in Patients With HER2-Negative, Germline BRCA-Mutated Advanced Breast Cancer
Patients with advanced or metastatic HER2-negative breast cancer with a germline BRCA mutation demonstrated significantly improved progression-free survival (PFS) with the addition of the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib to chemotherapy (comprised of carboplatin/paclitaxel)...
Rituximab Maintenance Adds No Benefit for Patients With Diffuse Large B-Cell Lymphoma
After treatment with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), rituximab maintenance therapy seems to provide no additional benefit for patients with diffuse large B-cell lymphoma (DLBCL) in first complete remission, according to data from a phase III trial.1...
ESMO 2019: ASCEND-7: Ceritinib for Patients With ALK-Positive NSCLC Metastatic to the Brain
Patients with ALK-positive non–small cell lung cancer (NSCLC) that was metastatic to the brain at baseline demonstrated whole-body, intracranial, and extracranial responses following treatment with ceritinib, according to findings from the phase II ASCEND-7 study presented by Chow et al at the...
ESMO 2019: ctDNA as a Marker for Disease-Free Survival With Oxaliplatin Treatment in Stage III Colon Cancer
Patients with advanced colon cancer and plasma samples containing circulating tumor DNA (ctDNA) were less likely to achieve 2-year disease-free survival with oxaliplatin-based adjuvant treatment than patients with ctDNA-negative samples, according to findings presented at the European Society for...
ESMO 2019: Studies Show PARP Inhibitors Improve Survival, Reduce Risk of Disease Recurrence or Death in Newly Diagnosed Ovarian Cancer
Two studies presented at the European Society for Medical Oncology (ESMO) 2019 Congress showed the efficacy of poly ADP ribose polymerase (PARP) inhibitors in patients with newly diagnosed ovarian cancer. In the PRIMA/ENGOT-OV26/GOG-3012 study, presented by González Martín et al (Abstract LBA1;...
ESMO 2019: Tailored Treatment vs Empiric Chemotherapy for Cancer of an Unknown Primary
Treatment tailored by comprehensive molecular gene-expression analysis of tumors from patients with carcinomas of an unknown primary site did not improve progression-free survival vs empiric chemotherapy consisting of cisplatin/gemcitabine. Fizazi et al presented these findings at the European...
ESMO 2019: 5-Year Survival and Response With Nivolumab/Ipilimumab in Advanced Melanoma
An update of results of the phase III CheckMate 067 trial at 5 years presented by Larkin et al at the European Society for Medical Oncology (ESMO) 2019 Congress showed that both nivolumab in combination with ipilimumab and nivolumab alone provided significant improvements in overall survival,...
ADMIRAL Study Finds Gilteritinib Effective Across Mutation Cohorts of Acute Myeloid Leukemia
The novel FLT3 inhibitor gilteritinib prolonged survival in patients with FLT3-mutated relapsed or refractory acute myeloid leukemia (AML) across all mutation cohorts, including NPM1, DNMT3A, DNMT3A/NPM1, and WT1, with the greatest benefit seen in patients with NPM1 and DNMT3A co-mutations,...
Final Results of RESONATE Trial Show Long-Term Benefit of Ibrutinib in Relapsed or Refractory CLL
After 6 years of follow-up, extended treatment with ibrutinib showed sustained progression-free survival benefit and depth of response in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), including those with high-risk genomic features,...
ESMO 2019: First-Line Immunotherapy Shows Clinical Benefit in Advanced Hepatocellular Carcinoma
New data have shown a trend toward clinically meaningful improvements in survival and response rates and a favorable safety profile with first-line immunotherapy compared to current standard treatment for advanced hepatocellular carcinoma (HCC). The data, reported by Yau et al at the European...
FDA Approves Daratumumab Combination for Transplant-Eligible Patients With Multiple Myeloma
On September 26, 2019, the U.S. Food and Drug Administration approved daratumumab (Darzalex) in combination with bortezomib, thalidomide, and dexamethasone for newly diagnosed adult patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Efficacy was investigated ...
SOHO 2019: Fedratinib in Patients With Myelofibrosis: JAKARTA Trials Update
In analyses reported at the 2019 Society of Hematologic Oncology (SOHO) Annual Meeting and published in Clinical Lymphoma, Myeloma & Leukemia, Harrison et al identified response rates to the JAK2 inhibitor fedratinib among patients with myeloproliferative neoplasm–associated intermediate- or...
Tailoring Upfront Daratumumab Treatment for Some Patients With Multiple Myeloma
The monoclonal antibody daratumumab has been widely embraced for the treatment of multiple myeloma, but for newly diagnosed patients, its benefit has been proved only in some patients, according to Craig Hofmeister, MD, MPH, Associate Professor of Medicine at the Winship Cancer Institute of Emory...
Suboptimal Insurance Linked to Worse Survival Outcomes in Positive Clinical Trials
Findings from a recent SWOG study could cast doubt on the generalizability of treatment effects observed in positive clinical trials, especially among underinsured patients. According to data presented at the 2019 ASCO Quality Care Symposium,1 patients with Medicaid or no insurance had no observed...
Tumor Mutational Burden Disappoints as Biomarker for Treatment Response in Exploratory Analyses of Nonsquamous NSCLC
Tumor mutational burden failed to prove effective as a biomarker for response to chemotherapy plus checkpoint inhibitor or chemotherapy alone as first-line treatment for nonsquamous non–small cell lung cancer (NSCLC) in two different exploratory analyses of KEYNOTE trials.1,2 In both analyses,...
Benefits Reported With Addition of Isatuximab to Pomalidomide and Dexamethasone in Resistant Multiple Myeloma
In patients with relapsed or refractory multiple myeloma, isatuximab in combination with pomalidomide and low-dose dexamethasone nearly doubled progression-free survival when compared with pomalidomide and dexamethasone alone, with a manageable safety profile, according to data from a phase III...
Addition of Selective Internal Radiotherapy to Chemotherapy May Improve Resectability of Colorectal Cancer Liver Metastases
In a report published by Garlipp et al in the British Journal of Surgery, the addition of selective internal radiotherapy (SIRT) to modified FOLFOX6-based chemotherapy (mFOLFOX6; oxaliplatin/leucovorin/fluorouracil) improved the resectability of initially unresectable colorectal cancer liver...
FDA Approves Apalutamide for Metastatic Castration-Sensitive Prostate Cancer
On September 17, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with metastatic castration-sensitive prostate cancer. Apalutamide was initially approved by the FDA in 2018 for patients with nonmetastatic castration-resistant prostate cancer. TITAN Trial...
ASTRO 2019: Patterns of Disease Progression in Patients With Unresectable Stage III NSCLC: Analysis of the PACIFIC Trial
Andreas Rimner, MD, of Memorial Sloan Kettering Cancer Center, presented an update of the landmark PACIFIC trial at the 61st Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Abstract LBA-6). In earlier reports from the randomized phase III trial, Antonia et al had evaluated...
FDA Grants Approval to Lenvatinib/Pembrolizumab in Advanced Endometrial Cancer, Announces Project Orbis
The U.S. Food and Drug Administration (FDA) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the...
Targeting an Important Tumor Vulnerability With Maintenance Olaparib in Germline BRCA-Mutated Pancreatic Cancer
In the POLO trial, which is discussed in this issue of The ASCO Post, Golan and colleagues evaluated the potential benefit of maintenance olaparib after disease stability or response to a minimum of 4 months of platinum-based chemotherapy in patients with metastatic pancreatic cancer and a...
Conundrums in Managing Cancer-Associated Thrombosis
Although there may be a clear role for prophylactic anticoagulation in hospitalized patients and those undergoing surgery, indication for prophylactic anticoagulation for patients with cancer seen in the ambulatory setting has yet to emerge. Until clinical trial data on prophylactic...
ASTRO 2019: ORIOLE Trial: Observation vs SABR for Oligometastatic Prostate Cancer
The randomized, phase II ORIOLE trial studying the efficacy of targeted high-dose radiation for men with oligometastatic prostate cancer has shown that stereotactic ablative radiation (SABR) is an effective and safe option for patients who wish to delay hormone-suppression therapy. Data from the...
WCLC 2019: KEYNOTE-024 Survival Update Shows Benefit With Pembrolizumab vs Chemotherapy in Advanced NSCLC
First-line pembrolizumab monotherapy provides durable long-term overall survival benefit compared to chemotherapy in patients with advanced non–small cell lung cancer (NSCLC), according to data from the KEYNOTE-024 trial presented by Martin Reck, MD, PhD, at the International Association for the...
WCLC 2019: Final Overall Survival Results of IMpower131 Trial in Advanced Squamous NSCLC
Patients with stage IV squamous non–small cell lung cancer (NSCLC) with high programmed cell death ligand 1 (PD-L1) expression treated with atezolizumab and chemotherapy experienced longer overall survival rates than those treated with chemotherapy alone. The data from the IMpower131 trial were...
WCLC 2019: Autoantibody Diagnostic Test Followed by CT Imaging May Improve Diagnosis, Reduce Mortality in Lung Cancer
A combination of the EarlyCDT-Lung Test followed by computed tomography (CT) imaging in Scottish patients at risk for lung cancer resulted in a significant decrease in late-stage diagnosis of lung cancer and may decrease lung cancer–specific mortality, according to research presented at...
Olaparib Monotherapy Improves Outcomes in BRCA-Mutated, Platinum-Sensitive Relapsed Ovarian Cancer
Compared with treatment with nonplatinum-based chemotherapy, monotherapy with the PARP (poly [ADP ribose] polymerase) inhibitor olaparib led to statistically significant and clinically relevant improvements in overall response rate and progression-free survival in women with germline...
WCLC 2019: CASPIAN Trial Finds Addition of Durvalumab to Chemotherapy Improves Overall Survival in Patients With Extensive-Stage SCLC
The addition of durvalumab to chemotherapy improved overall survival in patients with extensive-stage small cell lung cancer (SCLC), according to research presented at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC) (Abstract PL02.11)....
WCLC 2019: Pooled Analysis of CheckMate 017 and 057: 5-Year Outcomes With Nivolumab vs Docetaxel in Previously Treated NSCLC
Pooled data on two clinical trials demonstrated patients with previously treated non–small cell lung cancer (NSCLC) treated with nivolumab had a greater than fivefold increase in 5-year overall survival rate compared to treatment with the chemotherapy docetaxel. Scott Gettinger, MD, of Yale...
Pembrolizumab in First-Line Treatment of Head/Neck Squamous Cell Carcinoma
On June 10, 2019, pembrolizumab was approved for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma.1,2 Pembrolizumab was approved for use in combination with platinum and fluorouracil (5-FU) for all patients and as a single agent...
Lenalidomide for Previously Treated Follicular and Marginal Zone Lymphomas
On May 28, 2019, lenalidomide was approved for use in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.1,2 Supporting Efficacy Data Approval was based on the findings of two clinical trials: AUGMENT (ClinicalTrials.gov...
Update on FDA-Approved CAR T-Cell Gene Therapy for B-Cell Lymphomas
On October 18, 2017, the U.S. Food and Drug Administration (FDA) granted approval to axicabtagene ciloleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma. Specifically, this treatment can be used after two or more lines of systemic therapy for diffuse...
Hey Siri, Should I Get a Medical Degree?
I received a coffee mug from a physician colleague some years ago with the tag line: “Please do not confuse your Google search with my Medical Degree.” Physicians of all stripes and colors can relate to the agony of debunking a “Dr. Google” diagnosis. However, in a fast-evolving health-care...
WCLC 2019: Two Studies Show Tumor Mutational Burden Not Associated With Pembrolizumab Efficacy in NSCLC
At the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC), two presentations showed that tumor mutational burden is not associated with the efficacy of pembrolizumab in combination with chemotherapy in patients with non–small cell lung cancer...
First-Line Nivolumab and Ipilimumab vs Sunitinib in Advanced Renal Cell Carcinoma
This week, we’ll be talking about an extended follow-up of a phase III trial that investigated first-line nivolumab and ipilimumab vs sunitinib in advanced renal cell carcinoma. Then we’ll go over a research letter that identified strong predictors of response to immune checkpoint inhibitor...
Is It Time to Intervene in Smoldering Myeloma?
Early intervention in smoldering multiple myeloma prevents progression to symptomatic disease and should be strongly considered for patients meeting new criteria for high risk, according to Sagar Lonial, MD, Professor and Chair of Hematology and Medical Oncology and the Anne and Bernard Gray...
Study Explores Efficacy of Lower-Dose Olanzapine in Combination With Standard Antiemetic Regimen
Olanzapine at a 5-mg dose, when combined with aprepitant, palonosetron, and dexamethasone, significantly reduced the risk of delayed nausea and vomiting in patients receiving cisplatin-based chemotherapy, according to new research. The study investigators believe this approach may be considered a...
Extended Follow-up of CheckMate 214: Nivolumab/Ipilimumab vs Sunitinib as First-Line Treatment for Advanced RCC
As reported in The Lancet Oncology by Robert J. Motzer, MD, and colleagues, extended follow-up of the phase III CheckMate 214 trial has shown a maintained survival benefit for first-line nivolumab/ipilimumab vs sunitinib in patients with previously untreated intermediate- or poor-risk advanced...
Novel Treatments Under Study in Renal Cell Carcinoma and Prostate Cancer
There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...
Tumor Size and Grade Matter, and Ovarian Ablation by Chemotherapy May Explain Subgroup Anomaly in TAILORx
At the 2019 ASCO Annual Meeting, and simultaneously in The New England Journal of Medicine, we heard the third paper reporting results from TAILORx.1,2 The first, in 2015,3 indicated that women with node-negative breast cancers with Oncotype DX recurrence scores less than 11 did extremely well...
Novel Treatments Under Study in Renal Cell Carcinoma and Prostate Cancer
There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...
Selinexor in Relapsed or Refractory Multiple Myeloma
In the Clinic provides overviews of novel hematology and oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 3, 2019, the oral nuclear export...
FDA Approves Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
ON JULY 30, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa) for the treatment of nonmetastatic castration-resistant prostate cancer. Approval was based on the ARAMIS study, a multicenter, double-blind, placebo-controlled clinical trial of 1,509 patients with nonmetastatic ...
