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Showing 2801 - 2850FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma
Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...
Novel Therapy Reduces Duration of Chemoradiotherapy-Induced Mucositis in Patients With Head and Neck Cancer
GC4419, A SMALL molecule superoxide dismutase mimetic, reduced the duration, incidence, and severity of chemoradiotherapy-induced mucositis in patients with locally advanced head and neck cancer, with a safety profile comparable to that of placebo. This finding comes from a randomized phase IIb...
More Antibody-Drug Conjugates Expected to Impact Treatment of Lymphoma
FOR THE TREATMENT of lymphoma, antibody-drug conjugates (ADCs) are becoming an important class of drugs, as described at the 2018 Pan Pacific Lymphoma Conference by Brad Kahl, MD, Professor of Medicine at Washington University School of Medicine, St. Louis.1 “We have one ADC—brentuximab vedotin...
Phase III ASTRAL-1 Study of Guadecitabine in Patients With Treatment-Naive AML Ineligible to Receive Intensive Induction Chemotherapy
Results were recently announced from the ASTRAL-1 study evaluating the efficacy and safety of guadecitabine in adults with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive induction chemotherapy. The study did not meet its co-primary endpoints: complete...
FDA Grants Breakthrough Therapy Designation to Lenvatinib Plus Pembrolizumab in Endometrial Carcinoma
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib (Lenvima) in combination with pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient...
Adjuvant Bevacizumab in High-Risk HER2-Negative Breast Cancer
In an article in the Journal of Clinical Oncology, Miller et al reported final results of the Eastern Cooperative Oncology Group phase III E5103 trial, initiated in 2007, which showed no benefit of adding bevacizumab (Avastin) to adjuvant therapy in patients with HER2-negative, node-positive or...
FDA Approves Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia
On July 20, 2018, the U.S. Food and Drug Administration approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Approval was based on an open-label, single-arm, multicenter...
Dabrafenib/Trametinib Combination Receives CHMP Recommendation for the Adjuvant Treatment of BRAF V600 Mutation–Positive Melanoma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of adult patients with stage III melanoma...
FDA Approves Iobenguane I-131 for Rare Adrenal Gland Tumors
On July 30, the U.S. Food and Drug Administration (FDA) approved iobenguane I-131 (Azedra) injection for adult and pediatric patients (12 years and older) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic...
IMpower 132: Atezolizumab in Combination With Pemetrexed and Platinum-Based Chemotherapy in Advanced Nonsquamous NSCLC
The phase III IMpower132 study met its co-primary endpoint of progression-free survival and demonstrated that the combination of atezolizumab (Tecentriq) plus chemotherapy (cisplatin or carboplatin plus pemetrexed [Alimta]) reduced the risk of disease worsening or death compared to chemotherapy...
FDA Approves Ivosidenib for IDH1-Mutated AML
Today, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (isocitrate dehydrogenase-1 [IDH1]...
In Case You Missed It: Update on Breast Cancer Research
The ASCO Post presents these brief summaries of important studies in breast cancer, presented at the 2018 ASCO Annual Meeting. Ribociclib Plus Fulvestrant in Metastatic Breast Cancer The benefit of an inhibitor of cyclin-dependent kinase 4/6 (CDK4/6) added to fulvestrant has now been proven to...
In Case You Missed It: Short Takes on Current Cancer Research
It would be impossible to cover all of the important presentations from the 5,000-plus abstracts accepted for the 2018 ASCO Annual Meeting. In addition to our regular meeting coverage of the top news stories, the following highlights focus on novel investigational approaches to therapy for various...
FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali) in combination with an aromatase inhibitor for premenopausal or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer as initial...
Atezolizumab Plus Chemotherapy Extends Survival in Squamous NSCLC Regardless of PD-L1 Level
Patients with advanced squamous non–small cell lung cancer (NSCLC) had a greater benefit from first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy vs chemotherapy alone in the randomized, phase III, IMpower131 clinical trial.1 At the landmark of 12-month...
8-Year Update of SOFT and TEXT Trials: Positive but Not Definitive
At the 2017 San Antonio Breast Cancer Symposium (SABCS), the International Breast Cancer Study Group (IBCSG) and its collaborators presented the 8-year updates of the key modern trials of ovarian function suppression after local treatment for young women with resected breast cancer.1 These updates...
Immunotherapy in Merkel Cell Carcinoma: ‘Field Has Been Thrown on Its Head’
At the 2018 ASCO Annual Meeting, investigators presented long-term follow-up data for immunotherapy in patients with Merkel cell carcinoma and new data for its use in the neoadjuvant setting. The results drew high interest from attendees and a number of questions were raised following the...
Preliminary Data Suggest Neoadjuvant Chemoradiotherapy May Improve Outcomes in Patients With Early Stages of Pancreatic Cancer
For patients with newly diagnosed, potentially resectable pancreatic cancer, neoadjuvant chemoradiotherapy led to better outcomes when compared with immediate surgery followed by chemoradiotherapy in the phase III PREOPANC-1 trial. Approximately 25% fewer deaths occurred among patients in the...
Human Papillomavirus Vaccine in Cutaneous Basaloid Squamous Cell Carcinomas
Squamous cell carcinoma is the second-most-common form of skin cancer. Evidence suggests the human papillomavirus (HPV) plays a role in the development of some types of this skin cancer. Two years ago, a 97-year-old woman whose right leg was covered with squamous cell tumors went to see...
Treatment Beyond Disease Progression in Melanoma: Challenge Centers on Knowing Who May Benefit
Dr. Weiss is Assistant Professor (Medical Oncology), Developmental Therapeutics, Melanoma Program, Yale Cancer Center. Dr. Sznol is Professor of Medicine (Medical Oncology); Co-Director, Cancer Immunology Program, Yale Cancer Center Co-Director, Yale SPORE in Skin Cancer, New Haven, Connecticut. ...
Early Data Suggest TLR9 Agonist May Combat PD-1 Resistance in Advanced Melanoma
COMBINING CMP-001, a Toll-like receptor 9 (TLR9) agonist, plus pembrolizumab (Keytruda) appears to overcome resistance to anti–programmed cell death protein 1 (anti–PD-1) therapy, according to a preliminary phase Ib study.1 Adding CMP-001 to pembrolizumab was well tolerated, with antitumor efficacy ...
Study of PI3K Inhibitor Added to Fulvestrant in Advanced Breast Cancer Affirms Proof-of-Principle
IN PATIENTS with advanced breast cancer harboring a PIK3CA mutation, the addition of the PI3 kinase (PI3K) inhibitor taselisib to endocrine therapy with fulvestrant (Faslodex) significantly improved progression-free survival compared with fulvestrant alone, in the international phase III SANDPIPER...
More Evidence of Benefit With Immunotherapy and Chemotherapy in Nonsquamous Non–Small Cell Lung Cancer
ATEZOLIZUMAB (TECENTRIQ) plus bevacizumab (Avastin) plus a platinum doublet (ABCP) improved overall survival by 22% compared with bevacizumab plus a platinum doublet (BCP) in patients with advanced wild-type (without an identified mutation) nonsquamous non–small cell lung cancer (NSCLC), according...
Chemotherapy-Free Regimen Comparable to Rituximab-Chemotherapy as Front-Line Therapy for Follicular Lymphoma
IN PATIENTS with previously untreated advanced follicular lymphoma, the chemotherapy-free combination of rituximab (Rituxan) plus lenalidomide (Revlimid), the so-called R-squared (R2) regimen, yielded outcomes as good as those in patients who received standard rituximab-chemotherapy, in the interim ...
With European Protocol, Maintenance Therapy Improved 5-Year Survival in Rhabdomyosarcoma
THE ADDITION OF 6 months of maintenance chemotherapy in the treatment of rhabdomyosarcoma improved 5-year survival by 13%, in the European RMS2005 Maintenance study reported at the 2018 ASCO Annual Meeting.1 “At the end of this long, not-easy study, we concluded that maintenance is an effective and ...
Expert Point of View: Susan O'Brien, MD, and Bruce Cheson, MD
SUSAN O’BRIEN, MD, Associate Director for Clinical Science, Chao Family Comprehensive Cancer Center, University of California Irvine Health, told The ASCO Post that the pairing of ibrutinib (Imbruvica) and venetoclax (Venclexta) “is clearly a very powerful combination.” The next question, she...
KEYNOTE-407: Pembrolizumab Plus Chemotherapy Benefits Response, Survival in Squamous NSCLC
THE COMBINATION of pembrolizumab (Keytruda) plus platinum-based chemotherapy improved overall survival, response rates, and duration of response in patients with advanced squamous cell non–small cell lung cancer (NSCLC) compared with chemotherapy alone irrespective of programmed cell death ligand 1 ...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) in patients with advanced BRAF V600–mutant melanoma, as detected by an FDA-approved test.1 Dual targeting of the MAPK...
IMpassion130: Atezolizumab Plus Nab-Paclitaxel in Metastatic or Locally Advanced Triple-Negative Breast Cancer
The phase III IMpassion130 study has met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) as first-line treatment significantly reduced the risk of disease worsening or death in patients...
FDA Accepts sNDA for Ibrutinib Plus Rituximab in Waldenström’s Macroglobulinemia
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) in combination with rituximab (Rituxan) as a new treatment option for Waldenström's macroglobulinemia. If approved, the sNDA would expand the...
IMpower133: Atezolizumab in Combination With Chemotherapy in Previously Untreated, Extensive-Stage Small Cell Lung Cancer
The phase III IMpower133 study recently met its coprimary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis. The study demonstrated that first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy (carboplatin and...
FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations
Today, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) and binimetinib (Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on the randomized,...
FDA Approves Bevacizumab in Combination With Chemotherapy for Ovarian Cancer
ON JUNE 13, 2018, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) for the treatment of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV...
Pembrolizumab Receives FDA Approval for Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma, Advanced Cervical Cancer
THE U.S. FOOD and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or who have relapsed after two or more prior lines of therapy on June 13, 2018. The newest ...
Green Tea
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, present information on the potential health benefits ...
AJCC Breast Cancer Staging System More Clinically Relevant
THE RECENTLY issued 8th revision to the American Joint Committee on Cancer (AJCC) Breast Cancer Staging System incorporates tumor biology and prognostic stage groups and thus has become more accurate and clinically relevant, according to two speakers at the 2018 Miami Breast Cancer Conference.1,2...
Prostate Cancer Therapy in Evolution: Time to Rethink and Redirect?
The ASCO updated guidelines on the treatment of metastatic non-castrate prostate cancer penned by Morris and his colleagues1 provide valuable information annotated to the strengths of evidence in recently reported prostate cancer studies. CHAARTED, GETUG-AFU 15, LATITUDE, and STAMPEDE have...
Nivolumab Plus Ipilimumab Improves Progression-Free Survival in NSCLC With High Tumor Mutational Burden
The combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) improved progression-free survival compared with chemotherapy as first-line treatment for patients with advanced non–small cell lung cancer (NSCLC) and a high tumor mutational burden irrespective of programmed cell death ligand 1...
Expert Point of View: Kenneth C. Anderson, MD, FASCO, Adam D. Cohen, MD, Craig Hofmeister, MD, MPH, and Bruce Cheson, MD
Kenneth C. Anderson, MD, FASCO, of Dana-Farber Cancer Institute, Boston, noted that the iNNOVATE trial is the first randomized comparison of ibrutinib (Imbruvica) plus rituximab (Rituxan) vs “a very active control—rituximab—to which 50% of patients responded.” The study showed that “the...
Outcomes in Waldenström’s Macroglobulinemia Improved With Ibrutinib Plus Rituximab
In patients with Waldenström’s macroglobulinemia, the risk of disease progression was reduced by 80% with the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) over rituximab alone, in the international phase III iNNOVATE trial, reported at the 2018 ASCO Annual Meeting1 and...
Expert Point of View: Andrew Epstein, MD
“This is a very important study,” said ASCO expert Andrew Epstein, MD, of Memorial Sloan Kettering Cancer Center (MSK), New York. “Hyperthermic intraperitoneal chemotherapy is used in the United States and elsewhere, even though the benefits are unknown. This study shows there are no benefits, and ...
Less Is More: No Benefit Reported for Hyperthermic Intraperitoneal Chemotherapy in Colorectal Cancer
With a growing emphasis on value in cancer care, some types of resource-intensive therapies may need to be reconsidered. One such treatment may be hyperthermic intraperitoneal chemotherapy, which showed no benefit during surgery for colorectal cancer confined to the peritoneum in the PRODIGE 7...
Expert Point of View: Charles G. Drake, MD, PhD and Hatem H. Soliman, MD
Formal discussant of the GeparNuevo presentation, Charles G. Drake, MD, PhD, of the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, New York, said, “It is important that neoadjuvant immunotherapy combinations are being studied. There is a lot of enthusiasm for...
Priming the Immune System: Neoadjuvant Durvalumab Plus Chemotherapy May Be Beneficial in Triple-Negative Breast Cancer
The addition of durvalumab -(Imfinzi) to anthracycline/taxane-based chemotherapy had encouraging results as neoadjuvant therapy for early triple-negative breast cancer in the randomized phase II GeparNuevo study presented at the 2018 ASCO Annual Meeting.1 The results were positive in a subgroup of...
Nephrectomy May Be Avoided in Some Patients With Advanced Renal Cell Carcinoma
In the modern era of targeted therapy, some patients with metastatic renal cell carcinoma may be able to forgo nephrectomy and be treated with sunitinib (Sutent) alone, according to results of the phase III CARMENA trial reported during the Plenary Session at the 2018 ASCO Annual Meeting.1 The...
The Raven
The call from the dermatologist came at noon on Good Friday, just after my wife left with our two young daughters for a week on her family’s tree farm in Northern Michigan. I was on call for the hospital inpatient leukemia service, so I could not join them. When the dermatologist solemnly began,...
EHA 2018: Ruxolitinib Reduces Risk of Thrombosis, Death in Patients With Polycythemia Vera
A new comparison study showed that among polycythemia vera patients who were resistant or intolerant to hydroxyurea, those treated with ruxolitinib (Jakavi) had a significantly reduced risk of thrombosis and death compared to those who received best available therapy. The study findings are based...
EHA 2018: Single-Agent Quizartinib vs Chemotherapy in Relapsed or Refractory AML
Results from the phase III QuANTUM-R study of single-agent quizartinib in relapsed or refractory acute myeloid leukemia (AML) were presented by Cortes et al at the 23rd Annual Congress of the European Hematology Association (EHA) (Abstract LB2600). Study Findings QuANTUM-R study results showed...
Adjuvant Modified FOLFIRINOX Yields Unprecedented Survival in Pancreatic Cancer
Adjuvant treatment with modified FOLFIRINOX resulted in the longest overall survival yet reported for patients with resected pancreatic cancer, according to the results of the phase III Unicancer GI PRODIGE 24/CCTG PA.6 trial, presented at the 2018 ASCO Annual Meeting.1 With adjuvant modified...
EHA 2018: Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone vs Pomalidomide/Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma
The ELOQUENT-3 trial, an international phase II study evaluating the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma, achieved its primary endpoint, showing a statistically significant and clinically...
