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Showing 5651 - 5700Epacadostat Combined With Pembrolizumab in Patients With Unresectable or Metastatic Melanoma
On April 6, an external data monitoring committee commented on results from the phase III ECHO-301/KEYNOTE-252 trial of the investigational IDO1 inhibitor epacadostat plus pembrolizumab (Keytruda) in patients with unresectable or metastatic melanoma. The committee determined that the study did not...
FDA Accepts New Drug Application, Grants Priority Review for Duvelisib in CLL/SLL and Follicular Lymphoma
On April 9, the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review a new drug application (NDA) for the oral agent duvelisib, a first-in-class, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. The NDA is seeking full approval for duvelisib in...
ELCC 2018: Alectinib Provides Longer Symptom Improvement Than Crizotinib in ALK-Positive Lung Cancer
Alectinib provides longer symptom improvement than crizotinib in <em>ALK</em>-positive non–small cell lung cancer (NSCLC), according to results from the ALEX trial presented by Pérol et al at the European Lung Cancer Congress (ELCC) in Geneva, Switzerland (Abstract...
ASCO Clinical Practice Guideline: Optimizing Anticancer Therapy in Metastatic Noncastrate Prostate Cancer
As reported in the Journal of Clinical Oncology by Michael J. Morris, MD, of Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, and colleagues, ASCO has released a clinical practice guideline on optimizing anticancer therapy in men with metastatic noncastrate prostate cancer. To...
Updated ASTRO Guideline for Palliative Radiotherapy in Lung Cancer
The American Society for Radiation Oncology (ASTRO) has issued an update to its clinical guideline for the use of palliative-intent radiation therapy for patients with incurable non–small cell lung cancer (NSCLC). Reflecting new evidence from randomized clinical trials, the guideline now...
Selinexor Receives Fast Track Designation From the FDA in Pentarefractory Multiple Myeloma
On April 10, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the oral selective inhibitor of nuclear export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy. The FDA’s...
FDA and EMA Accept Regulatory Submissions for Dacomitinib in Metastatic NSCLC With EGFR-Activating Mutations
On April 4, Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted the company’s new drug application and granted Priority Review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the first-line treatment of...
Adjuvant Chemotherapy Duration in Stage III Colon Cancer
In a preplanned pooled analysis of phase III trials reported in The New England Journal of Medicine, Grothey et al did not establish noninferiority of 3 vs 6 months of adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine and oxaliplatin) in disease-free survival in...
Updated Analysis of Obinutuzumab in Rituximab-Refractory Indolent Non-Hodgkin Lymphoma
As reported in the Journal of Clinical Oncology by Cheson et al, an updated analysis of the phase III GADOLIN trial showed an overall survival advantage with obinutuzumab (Gazyva) plus bendamustine induction followed by obinutuzumab maintenance vs bendamustine alone in patients with rituximab...
FDA Expands Rucaparib Approval to Include Maintenance Treatment of Recurrent Ovarian Cancer
Today, the U.S. Food and Drug Administration (FDA) approved rucaparib (Rubraca) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The FDA...
Phase III REACH-2 Study in Hepatocellular Carcinoma Meets Overall Survival Endpoint
Topline results from the phase III REACH-2 study of ramucirumab (Cyramza) as a single agent in the second-line treatment of patients with hepatocellular carcinoma (HCC) were recently announced. The trial met its primary endpoint of overall survival as well as the secondary endpoint of...
Nivolumab Plus Ipilimumab vs Sunitinib in Previously Untreated Advanced RCC
As reported in The New England Journal of Medicine by Motzer et al, the phase III CheckMate 214 trial has shown an overall survival advantage with nivolumab plus ipilimumab vs sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC). Study Details In the open-label...
Future Looks Brighter for Treatment of Cholangiocarcinoma
THE INCIDENCE of cholangiocarcinoma is rising, and effective therapies are urgently needed. Several classes of experimental molecularly targeted agents might meet this challenge, according to Robin Kate Kelley, MD, Associate Professor of Medical Oncology and leader of the clinical trials program in ...
Four Years Posttreatment, Exercise Improves Physical Activity Levels, Reduces Fatigue in Patients With Breast and Colon Cancers
IN PATIENTS WITH breast and colon cancers, a physical exercise intervention conducted during adjuvant chemotherapy improved total physical activity levels 4 years after treatment, with a trend toward less fatigue, according to a follow-up study from the randomized multicenter PACT study, presented...
FDA Expands Approval of Brentuximab Vedotin in Classical Hodgkin Lymphoma
ON MARCH 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris), an antibody-drug conjugate, to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. Brentuximab vedotin combines an antibody and...
FDA Accepts BLA for Moxetumomab Pasudotox in Hairy Cell Leukemia
On April 3, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at ...
Phase II Study Shows Durvalumab Active in Patients With Recurrent or Metastatic Head and Neck Cancer
IN A POPULATION of heavily pretreated patients with recurrent or metastatic head and neck cancer and low or negative programmed cell death ligand 1 (PD-L1) expression, durvalumab (Imfinzi) monotherapy demonstrated an overall response rate of 9.2%, consistent with that of single-agent programmed...
Delays in Radiation Therapy After Surgery for Head and Neck Cancer Linked to Decreased Survival
DELAYS IN RADIATION THERAPY after surgery for head and neck cancer were associated with decreased survival in a large population of U.S. patients, according to data presented at the 2018 Multidisciplinary Head and Neck Cancers Symposium and reported online recently in JAMA Otolaryngology Head & ...
Potent Anti-HER2 Agents on the Horizon
THANKS TO the efficacy of five approved anti-HER2 agents, patients with HER2-positive breast cancer have overall survival numbers that are as good as, or better than, their HER2-negative counterparts. With the next generation of anti-HER2 therapies in clinical trials, these outcomes may become even ...
Encorafenib Plus Binimetinib Improves Progression-Free Survival vs Vemurafenib in Advanced BRAF-Mutant Melanoma
IN THE PHASE III COLUMBUS trial reported in The Lancet Oncology, Reinhard Dummer, MD, of University Hospital Zurich, and colleagues found that the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib improved progression-free survival vs vemurafenib (Zelboraf) in...
Undefeated
I’m sure every cancer survivor feels this way, but my diagnosis, in 1997, of stage III germ cell testicular cancer couldn’t have come at a worse time in my life. I was nearing the end of a 60-city tour with my figure skating show Stars on Ice, when a nagging pain in my abdomen became so severe I...
More on the ABCSG-16 Trial
Postmenopausal women with hormone receptor–positive breast cancer who took the aromatase inhibitor anastrozole for 2 years after an initial 5 years of adjuvant endocrine therapy received an equal benefit to those who took the drug for 5 additional years. The trial results suggest that a shorter...
SGO 2018: Participation in Clinical Trials May Overcome Health Disparities in Ovarian Cancer
Participation in clinical trials may overcome health disparities in the treatment of advanced or recurrent ovarian cancer, according to a study presented at the Society of Gynecologic Oncology’s (SGO) 2018 Annual Meeting on Women’s Cancer (Abstract 6). The study evaluated the effect of ...
Acupuncture for Joint Pain Associated With Aromatase Inhibition
Although aromatase inhibitors are highly effective as adjuvant therapy in metastatic breast cancer and for prevention of breast cancer, the side effects can be difficult to tolerate and often lead to discontinuation of therapy. A phase III randomized trial has found that acupuncture may relieve...
IMpower150: Increased OS With Atezolizumab/Bevacizumab Plus Chemotherapy in Advanced Nonsquamous NSCLC
The phase III IMpower150 study met its coprimary endpoint of overall survival (OS) at interim analysis and showed that first-line treatment with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) plus carboplatin and paclitaxel (chemotherapy) helped patients with advanced...
Addition of Trastuzumab to Carboplatin/Paclitaxel in HER2-Positive Uterine Serous Carcinoma
In a phase II trial reported in the Journal of Clinical Oncology, Fader et al found that the addition of trastuzumab (Herceptin) to carboplatin/paclitaxel improved progression-free survival among women with HER2-overexpressing uterine serous carcinoma. HER2 has been found to be overexpressed in...
First Interim Analysis of Phase III SEQUOIA Trial in Pancreatic Cancer
ARMO BioSciences, Inc, recently announced the completion of the first interim analysis in its phase III SEQUOIA trial in patients with pancreatic cancer. The Data Monitoring Committee (DMC) for SEQUOIA, a clinical trial studying pegilodecakin (AM0010) plus FOLFOX (leucovorin,...
Modified XELIRI vs FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer
In an Asian phase III noninferiority trial (AXEPT) reported in The Lancet Oncology, Xu et al found that modified XELIRI (mXELIRI, capecitabine plus irinotecan) was noninferior in overall survival vs standard FOLFIRI (leucovorin, fluorouracil, and irinotecan), both given with or without bevacizumab...
Venetoclax Plus Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia
In the phase III MURANO trial reported in The New England Journal of Medicine by Seymour et al, the combination of the BCL2 inhibitor venetoclax (Venclexta) with rituximab (Rituxan) markedly improved progression-free survival vs bendamustine plus rituximab in patients with relapsed or refractory...
Lenvatinib Mesylate Approved in Japan for Unresectable HCC
On March 23, the multiple-receptor tyrosine kinase inhibitor lenvatinib mesylate (Lenvima) was approved in Japan for unresectable hepatocellular carcinoma (HCC). This is the first approval worldwide of lenvatinib mesylate for the indication of unresectable HCC and the first new systemic therapy to...
SSO 2018: Outcomes of Patients With Metastatic Melanoma Selected for Surgery After Immunotherapy
Immunotherapy has transformed the treatment of metastatic melanoma, with 3-year survival rates surpassing 50% for appropriate patients. However, many of these patients still require surgery, but very little research has been done on this group of patients to determine whether surgery after...
IMpower131 Study: Atezolizumab Plus Chemotherapy in Advanced Squamous NSCLC
On March 20, Genentech announced that the phase III IMpower131 study met its coprimary endpoint of progression-free survival (PFS) and demonstrated that the combination of atezolizumab (Tecentriq) plus chemotherapy (carboplatin and nanopartical albumin-bound [nab]-paclitaxel [Abraxane])...
Duration of Adjuvant Oxaliplatin-Based Therapy for Stage III Colon Cancer
“At Microphone 1” is an occasional column written by Steven E. Vogl, MD, of the Bronx, New York. When he is not in his clinic, he can generally be found at major oncology meetings and often at the microphone, where he stands ready with critical questions for presenters of new data. The opinions...
Unique CAR T-Cell Construct Studied in Multiple Myeloma
CD19-DIRECTED chimeric antigen receptor (CAR) T-cell therapy has been approved by the U.S. Food and Drug Administration for the treatment of leukemia (tisagenlecleucel [Kymriah]) and lymphoma (axicabtagene ciloleucel [Yescarta]), but another type of CAR T-cell therapy is generating interest as a...
Encorafenib Plus Binimetinib vs Vemurafenib and Encorafenib Alone in Advanced BRAF-Mutant Melanoma
In the phase III COLUMBUS trial reported in The Lancet Oncology, Dummer et al found that the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib improved progression-free survival vs vemurafenib (Zelboraf) in patients with advanced BRAF V600–mutant melanoma....
Postoperative Chemoradiotherapy vs Radiotherapy in High-Risk Cutaneous Squamous Cell Carcinoma of the Head and Neck
In an Australia-New Zealand phase III trial (Trans Tasman Radiation Oncology Group 05.01) reported in the Journal of Clinical Oncology, Porceddu et al found no benefit of adding carboplatin to postoperative radiation therapy in patients with high-risk cutaneous squamous cell carcinoma of the head...
MEK1/2 Inhibition in Metastatic Uveal Melanoma
In a phase III trial (SUMIT) reported in the Journal of Clinical Oncology, Carvajal et al found that the addition of the oral MEK1/2 inhibitor selumetinib to dacarbazine did not significantly improve progression-free survival in patients with metastatic uveal melanoma. Study Details In the...
FDA Grants Priority Review to sNDA for Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
On March 19, a supplemental New Drug Application (sNDA) for enzalutamide (Xtandi) was accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). If approved, the sNDA would expand the indication of enzalutamide to include men with nonmetastatic...
FDA Expands Approval of Brentuximab Vedotin for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination With Chemotherapy
On March 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. “Today’s approval represents an improvement in the initial...
Activity of Combined Immune Checkpoint and VEGF Inhibition as First-Line Therapy in Advanced Clear Cell RCC
In the dose-finding, dose-expansion phase Ib JAVELIN Renal 100 trial reported in The Lancet Oncology, Choueiri et al identified the maximum tolerated dose of the immune checkpoint inhibitor avelumab (Bavencio) in combination with the vascular endothelial growth factor inhibitor axitinib...
Ashwagandha
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. In this installment, Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, present information on...
Triplet Therapy Poses a Triple Threat to BRAF-Mutated Colorectal Cancers
Triplet therapy that inhibits the BRAF, MEK, and epidermal growth factor receptor (EGFR) pathways appears promising in BRAF-mutated colorectal cancer, a malignancy that typically does not respond to BRAF inhibition alone. Early results from the BEACON CRC study showed a 48% response rate and an...
Studies Explore Colon Tumor Sidedness, Lung Radiation Dose in Esophageal Cancer, Pembrolizumab in Liver Cancer, and More
Along with full coverage of key presentations from the 2018 Gastrointestinal Cancers Symposium, The ASCO Post brings our readers this additional news roundup. Side Matters in Colon Cancer One of the studies included in the global IDEA trial, which compared 3 vs 6 months of adjuvant chemotherapy in ...
Positive Preliminary Data Seen for Axitinib Plus Pembrolizumab in Renal Cell Carcinoma
The combination of axitinib (Inlyta) plus pembrolizumab (Keytruda) can be added to the list of combination therapies that look promising in advanced renal cell carcinoma. In a phase Ib trial, almost three-quarters of patients with newly diagnosed advanced renal cell carcinoma treated with the...
Pembrolizumab Survival Advantage Upheld in Advanced Urothelial Carcinoma
Patients with recurrent urothelial cancer had sustained improvement in overall survival at 2 years after they received second-line treatment with pembrolizumab (Keytruda) vs chemotherapy, according to an updated survival analysis of the phase III KEYNOTE-045 trial presented at the 2018...
Expert Point of View: Francis P. Worden, MD
The moderator of the session, Francis P. Worden, MD, a medical oncologist at the University of Michigan Health System Comprehensive Cancer Center, in Ann Arbor, highlighted the number of poorly differentiated carcinomas, which is higher than reported in other previous, large studies. “In previous...
Cabozantinib Therapy Shows Activity in Differentiated Thyroid Cancer
Cabozantinib (Cometriq) has demonstrated significant activity in the first-line setting for radioiodine-refractory differentiated thyroid carcinoma, according to data from a single-site phase II trial presented at the 2018 Multidisciplinary Head and Neck Cancers Symposium.1 Treatment with...
Prognostic Factors for Complete Response to Ibrutinib in Chronic Lymphocytic Leukemia
In an analysis of two pooled studies reported in JAMA Oncology, O’Brien et al found that a complete response to ibrutinib (Imbruvica) in the treatment of chronic lymphocytic leukemia was more likely in patients receiving the agent as first-line therapy and in those without bulky disease....
Radioembolization vs Sorafenib in Asia-Pacific Patients With Hepatocellular Carcinoma
In an investigator-initiated phase III SIRveNIB trial in Asia-Pacific patients reported in the Journal of Clinical Oncology, Chow et al found no difference in overall survival with selective internal radiation therapy, or radioembolization, vs sorafenib (Nexavar) in patients with unresectable...
Concurrent Chemoradiotherapy With Nedaplatin vs Cisplatin in Nasopharyngeal Carcinoma
As reported in The Lancet Oncology by Tang et al, a Chinese phase III noninferiority trial has shown similar progression-free survival with nedaplatin- vs cisplatin-based chemoradiotherapy in patients with stage II to IVB nasopharyngeal carcinoma, with nedaplatin being associated with fewer severe...
