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Showing 751 - 800Addition of EGFR-Targeting Vaccine to Temozolomide in EGFRvIII-Expressing Glioblastoma
The phase III ACT IV study has shown no survival benefit of adding rindopepimut, a vaccine targeting the epidermal growth factor receptor (EGFR) deletion mutation EGFRvIII, to temozolomide in patients with newly diagnosed EGFRvIII-positive glioblastoma. These findings were reported by Weller et al...
Atezolizumab in Patients With Advanced Urothelial Carcinoma Who Are Ineligible for Cisplatin
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 17, 2017, the programmed cell death ligand 1 (PD-L1)...
Overall Survival With Carfilzomib vs Bortezomib in Relapsed or Refractory Multiple Myeloma
As reported by Dimopoulos et al in The Lancet Oncology, a prespecified interim analysis of the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma. Carfilzomib was...
FDA Approves First CAR T-Cell Therapy for Pediatric and Young Adult Patients With B-Cell Precursor ALL
Today, the U.S. Food and Drug Administration (FDA) issued what it has called a “historic action,” making the first gene therapy available in the United States. The FDA approved tisagenlecleucel (Kymriah) for certain pediatric and young adult patients with a form of acute lymphoblastic...
Phase III ALCYONE Study of Daratumumab in Front-Line Treatment of Multiple Myeloma
On August 24, positive topline results were announced from the phase III ALCYONE study of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) vs VMP alone as front-line treatment for newly diagnosed patients who are not considered candidates for...
ASCO, CCF Congratulate 2017 Grant and Award Recipients
The Conquer Cancer Foundation of ASCO (CCF) presented more than $6.3 million in grants and awards to 247 promising oncology researchers at the 2017 ASCO Annual Meeting. CCF and ASCO congratulate the recipients on their contributions to the field of oncology and offer their profound thanks to the...
Crizotinib in Pediatric ALK-Positive Anaplastic Large Cell Lymphoma and Inflammatory Myofibroblastic Tumors
In a Children’s Oncology Group study, high response rates were achieved with crizotinib (Xalkori) treatment in pediatric ALK-positive anaplastic large cell lymphomas (ALCL) and inflammatory myofibroblastic tumors. These results were reported by Mossé et al in the Journal of Clinical...
International Consensus (or Not) on Management of Advanced Prostate Cancer
ALTHOUGH THE National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) strongly influence the management of advanced prostate cancer, they do not always reflect actual clinical practice. It turns out that in the real world, there are multiple areas ...
Standard-Dose Pembrolizumab Plus Reduced-Dose Ipilimumab in Advanced Melanoma
In the phase IB KEYNOTE-029 study, standard-dose pembrolizumab (Keytruda) plus reduced-dose ipilimumab (Yervoy) produced high response rates in patients with advanced melanoma. These results were reported by Long et al in The Lancet Oncology. Study Details In the study, 153 patients with...
FDA Approves Three-Drug Combination Tablet for Hepatitis C
On July 18, the U.S. Food and Drug Administration (FDA) approved a combination tablet (Vosevi) to treat adults with chronic hepatitis C virus genotypes 1–6 without cirrhosis or with mild cirrhosis. This fixed-dose, combination tablet contains two previously approved drugs—sofosbuvir and ...
FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple NSCLC Therapies
On June 22, the U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing–based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non–small cell...
ASCO’s TAPUR Study Continues Its Expansion of Sites, Participants, and Collaborators
ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study continues to expand and now has more than 300 participants enrolled on study drugs, more than 100 sites in 20 states, new partnerships, and a -revised protocol to lower the age of eligibility. Recently, eight new centers in 36...
Expert Point of View: Leisha A. Emens, MD, PhD
STUDY DISCUSSANT Leisha A. Emens, MD, PhD, of Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University, Baltimore, entitled her remarks, “Target Practice in Triple-Negative Breast Cancer,” referring to the fact that there is currently no validated target in this aggressive...
CAR T-Cell Therapy in Multiple Myeloma Yields 100% Response Rate
Chinese investigators reported that 100% of patients with relapsed or refractory multiple myeloma responded to autologous chimeric antigen receptor (CAR) T-cell therapy, and 14 of 19 (74%) who were followed for a median of 4 months achieved a stringent complete response and have not recurred.1...
Expert Point of View: Leisha A. Emens, MD, PhD
Leisha A. Emens, MD, PhD, of the Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University, commented on the promise of anti–programmed cell death protein 1/programmed cell death ligand 1 (PD-1/PD-L1) agents in triple-negative breast cancer. She noted that “an emerging theme...
Adding Idelalisib to Bendamustine/Rituximab in Relapsed/Refractory CLL
As reported by Andrew D. Zelenetz, MD, of Memorial Sloan Kettering Cancer Center, and colleagues in The Lancet Oncology, interim analysis of a phase III trial has shown the superiority of adding the phosphoinositide-3-kinase δ inhibitor idelalisib (Zydelig) to bendamustine/rituximab (Rituxan) in...
FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
On July 3, the U.S. Food and Drug Administration (FDA) cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the...
FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...
First-Line Cetuximab vs Bevacizumab Plus Chemotherapy in KRAS Wild-Type Advanced Colorectal Cancer
A phase III trial has shown no significant difference in overall survival with first-line cetuximab (Erbitux) vs bevacizumab (Avastin) plus chemotherapy in patients with advanced or metastatic KRAS wild-type colorectal cancer. These study findings were reported by Venook et al in JAMA. The trial...
Brentuximab Vedotin vs Physician’s Choice in CD30-Positive Cutaneous T-Cell Lymphoma
The phase III ALCANZA trial has shown that brentuximab vedotin (Adcetris) produces a higher global response rate vs physician’s choice of therapy in previously treated CD30-positive cutaneous T-cell lymphomas. These results were reported by Prince et al in The Lancet. Study Details In this...
Equivalence Trial of Neoadjuvant Trastuzumab Biosimilar CT-P6 vs Trastuzumab in HER2-Positive Breast Cancer
A phase III equivalence trial has shown comparable pathologic complete response rates with the proposed trastuzumab biosimilar CT-P6 vs reference trastuzumab (Herceptin) in neoadjuvant treatment of HER2-positive early breast cancer. The study was reported by Stebbing et al in The Lancet Oncology....
ICML 2017: Phase III GENUINE Trial: Ublituximab Plus Ibrutinib in High-Risk CLL
Data was recently presented from the phase III GENUINE trial of ublituximab, a novel glycoengineered anti–CD20 monoclonal antibody, in combination with ibrutinib (Imbruvica), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of high-risk chronic lymphocytic leukemia (CLL), at the...
ICML 2017: Triplet Combination of Umbralisib, Ublituximab, and Ibrutinib in CLL/SLL/NHL
Data from the chemotherapy-free triple combination of umbralisib, an oral, next generation PI3K delta inhibitor; ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody; and ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and...
ASCO's TAPUR Study Continues Its Expansion of Sites, Participants, and Collaborators
ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study continues to expand and now has more than 300 participants enrolled on study drug, more than 100 sites, new partnerships, and a revised protocol to lower the age of eligibility. “We are very pleased with the...
ASCO 2017: Larotrectinib Shows Durable Efficacy Across Diverse Pediatric and Adult Cancers
Scientists may have developed the first targeted, oral, tumor-type agnostic therapy—an agent that works comparably well across many kinds of cancer, regardless of patient age. In clinical trials of adults and children with 17 different types of advanced cancer, larotrectinib treatment...
ASCO 2017: New High-Intensity Genomic Sequencing Approach Detects Circulating Tumor DNA at a High Rate
In a study of 124 patients with advanced breast, lung, and prostate cancers, a new high-intensity genomic sequencing approach detected circulating tumor DNA at a high rate. In 89% of patients, at least one genetic change detected in the tumor was also detected in the blood. Overall, 627 (73%)...
Palbociclib Combined With Aromatase Inhibitor in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
On March 31, 2017, palbociclib (Ibrance) was granted regular approval for treatment of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women.1,2 Palbociclib received...
Niraparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On March 27, 2017, the oral poly ADP-ribose polymerase (PARP) inhibitor niraparib (Zejula) was approved for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2...
New Immunotherapy Combinations Gain Ground in Advanced Melanoma, but Results Preliminary
Attention is focused among the cancer community on identifying the optimal immunotherapy combinations, with more than 800 ongoing trials of combination therapy. Two studies presented at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) reported promising preliminary...
SU2C Names Top Researchers to $12 Million Dream Team on Colorectal Cancer
Stand Up to Cancer (SU2C) announced the formation of a “Dream Team” of top researchers to take on one of the toughest challenges in cancer research and treatment: colorectal cancer, which is expected to claim the lives of more than 50,000 Americans this year. The announcement was made at a special...
AUA 2017: Phase III Study of Blue Light Cystoscopy With Optical Imaging Agent in Bladder Cancer
New phase III study results of blue light flexible cystoscopy (BLFC) with an optical imaging agent (Hexvix/Cysview) were presented by Daneshmand et al during a late-breaking plenary session at the 2017 American Urological Association (AUA) Annual Meeting (Abstract PPTLBA-02). Major Findings The...
Avelumab in Merkel Cell Carcinoma
On March 23, 2017, avelumab (Bavencio) was granted accelerated approval for treatment of patients aged ≥ 12 years with metastatic Merkel cell carcinoma. Avelumab is the first U.S. Food and Drug Administration–approved product to treat this disease.1,2 Supporting Efficacy Data Approval was based on ...
Continuing Education Information
This CE/CME/CEU-accredited supplement is jointly provided by To earn credit/contact hours, you must read all the articles in this supplement and then go to: https://education.annenberg.net/cdk46inhibition Release date: May 10, 2017 Expiration date: May 10, 2018Annenberg Center for Health...
Equivalent Response Rates With Trastuzumab or a Trastuzumab Biosimilar Plus Taxane in HER2-Positive Metastatic Breast Cancer
In part 1 of the Heritage study, a phase III equivalence trial reported in JAMA, Hope S. Rugo, MD, of the University of California Helen Diller Family Comprehensive Cancer Center, San Francisco, and colleagues found that treatment with trastuzumab (Herceptin) or a proposed trastuzumab biosimilar...
FNIH Awards Lurie Prize in Biomedical Sciences to David M. Sabatini, MD, PhD
The Foundation for the National Institutes of Health (FNIH) has selected David M. Sabatini, MD, PhD, to receive its 5th annual Lurie Prize in Biomedical Sciences for discovery of the mTOR (mechanistic target of rapamycin) cellular pathway as a key regulator of growth and metabolism in response to...
ASCO Honors Researchers, Scientists for Significant Advances in Cancer Treatment and Care
ASCO and the Conquer Cancer Foundation (CCF) proudly announce the winners of ASCO’s Special Awards, the Society’s highest honors, and the CCF Women Who Conquer Cancer Mentorship Award. The recipients of these awards include researchers, patient advocates, and global oncology leaders who have worked ...
Avelumab Produces Durable Responses in Merkel Cell Carcinoma, Becomes First Drug Approved for the Rare Disease
Avelumab (Bavencio) achieved durable responses in patients with metastatic Merkel cell carcinoma, according to longer-term follow-up of the phase II JAVELIN study, the largest study conducted to date in this relatively rare orphan cancer.1 Results were presented at the 2017 American Association for ...
FDA Removes Risk Evaluation and Mitigation Strategy Requirements for Erythropoiesis-Stimulating Agents
On April 13, the U.S. Food and Drug Administration (FDA) removed the risk evaluation and mitigation strategy (REMS) requirements for the use of epoetin alfa and darbepoetin alfa to treat patients with anemia due to associated myelosuppressive chemotherapy. The Agency's announcement regarding...
AACR 2017: Interim Results of Phase Ib/II Trial of Neratinib in Combination With Ado-trastuzumab Emtansine in HER2-Positive Metastatic Breast Cancer
Interim results from the phase Ib/II FB-10 clinical trial of neratinib given in combination with the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1, Kadcyla) were reported in a poster at the 2017 American Association for Cancer Research (AACR) Annual Meeting in Washington, DC, according...
Conquer Cancer Foundation Honors 65 Young Oncology Professionals With Merit Awards
The Conquer Cancer Foundation of ASCO (CCF) is pleased to announce the recipients of its 2017 CCF Merit Awards in Gastrointestinal Cancers, Cancer Survivorship, Genitourinary Cancers, Immuno-Oncology, and Quality Care. The following 65 young researchers, recognized for the scientific merit of their ...
JOP Publishes Clinical Pathways and Patient Safety Studies From Quality Care Symposium
The Journal of Oncology Practice (JOP) published three articles online in conjunction with the oral presentations of the data during ASCO’s 2017 Quality Care Symposium in Orlando. “The research presented at ASCO’s Quality Care Symposium enhances our understanding of a wide variety of methods to...
First-in-Human Clinical Trial of ONC201 in Patients With Refractory Solid Tumors
A first-in-human clinical trial examining the investigational small-molecule drug ONC201 in patients with advanced solid tumors showed the oral agent to be well tolerated at the recommended phase II dose, according to Rutgers Cancer Institute of New Jersey investigators whose research also showed...
Implications of SWOG S0777 and the Future of Combination Treatments for Multiple Myeloma
The treatment of multiple myeloma is becoming increasingly complicated. This is not only because of the complexity of the disease, but also because of the increasing number of effective combination treatments and continuous development of new drugs. This has resulted in an ever-increasing number ...
Expert Point of View: Nancy Baxter, MD, PhD & Steven H. Lin, MD, PhD
“CALGB 80803 really helps move the field forward,” said press briefing moderator and ASCO spokesperson Nancy Baxter, MD, PhD, a surgeon from St. Michael’s Hospital in Toronto, Ontario, Canada. “PET [positron-emission tomography] scans may prove to be a valuable tool to help oncologists fine-tune...
Spotlight: ASCO Clinical Affairs
ASCO is working—through research, education, and promotion of the highest quality patient care—toward a world where cancer is prevented or cured, and every survivor is healthy. With the goal of ensuring that all patients receive the high-quality care they expect and deserve, ASCO is committed to...
Ibrutinib in Marginal Zone Lymphoma
On January 19, ibrutinib (Imbruvica) was granted accelerated approved for treatment of patients with marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20–based therapy.1 Supporting Efficacy Data Approval was based on overall response rate in a...
Pembrolizumab in Locally Advanced or Metastatic Urothelial Cancer
As reported by Elizabeth R. Plimack, MD, of Fox Chase Cancer Center, Temple Health, and colleagues in The Lancet Oncology, pembrolizumab (Keytruda) has shown activity in patients in the locally advanced or metastatic urothelial carcinoma cohort included in the phase Ib KEYNOTE-012 trial. In the...
First-in-Class Rovalpituzumab Tesirine in Recurrent Small Cell Lung Cancer
In a phase I study reported in The Lancet Oncology, Charles M. Rudin, MD, of Memorial Sloan Kettering Cancer Center, and colleagues found that rovalpituzumab tesirine, a first-in-class antibody-drug conjugate directed against delta-like protein 3 (DLL3), produced responses in patients with...
Continuing Education Information
This CE/CME/CU-accredited supplement is jointly provided by: To earn credit/contact hours, you must read all the articles in this supplement and then go to https://education.annenberg.net/IASLC Release date: February 25, 2017 Expiration date: February 25, 2018Annenberg Center for Health...
Adding Idelalisib to Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
As reported by Zelenetz et al in The Lancet Oncology, an interim analysis of a phase III trial has shown the superiority of adding the phosphoinositide-3-kinase δ inhibitor idelalisib (Zydelig) to bendamustine/rituximab (Rituxan) in patients with relapsed or refractory chronic lymphocytic...
