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Showing 101 - 150KEYNOTE-224: Pembrolizumab in Advanced Hepatocellular Carcinoma Pretreated With Sorafenib
As reported in The Lancet Oncology by Zhu et al, the phase II KEYNOTE-224 study has shown activity of pembrolizumab in advanced hepatocellular carcinoma (HCC) pretreated with sorafenib. Study Details In the study, 104 eligible patients who were intolerant of or progressed on sorafenib were...
Nivolumab in Adjuvant Treatment of Melanoma
On December 20, 2017, nivolumab (Opdivo) was granted regular approval for adjuvant treatment of patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection.1,2 Nivolumab was previously approved for the treatment of patients with unresectable or...
Combined Immune Checkpoint and VEGF Inhibition as First-Line Therapy in Advanced Clear Cell Kidney Cancer
In a dose-finding, dose-expansion phase Ib trial (JAVELIN Renal 100) reported in The Lancet Oncology, Toni K. Choueiri, MD, of Dana-Farber Cancer Institute and Brigham and Women’s Hospital, and colleagues determined the maximum tolerated dose of the immune checkpoint inhibitor avelumab (Bavencio)...
IL-15 Superagonist Plus Nivolumab in Advanced NSCLC
In a phase Ib trial reported in The Lancet Oncology, Wrangle et al found evidence of activity of the combination of nivolumab (Opdivo) and the interleukin (IL)-15 superagonist ALT-803 in patients with previously treated advanced non–small cell lung cancer (NSCLC). ALT-803 targets the shared...
Larotrectinib in Pediatric Solid Tumors With TRK Gene Fusions
As reported in The Lancet Oncology by Laetsch et al, phase I results from an ongoing phase I/II trial have shown activity of the TRK kinase inhibitor larotrectinib in pediatric patients with solid tumors harboring TRK fusions. Study Details In the study, 24 patients in a dose-escalation cohort...
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...
First-Line Avelumab in Metastatic Merkel Cell Carcinoma
In a preplanned interim analysis of a phase II trial (JAVELIN Merkel 200 part B) reported in JAMA Oncology, D’Angelo et al found that avelumab was active in the first-line treatment of metastatic Merkel cell carcinoma. Avelumab was approved in March 2017 for treatment of patients aged ≥ 12 ...
FDA Expands Nilotinib Indication to Pediatric Patients With CML
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for nilotinib (Tasigna) to include treatment of first- and second-line pediatric patients 1 year of age or older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase. In the United...
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...
Bosutinib in Newly Diagnosed Chronic-Phase Philadelphia Chromosome–Positive Chronic Myeloid Leukemia
In the Clinic provides overviews of novel 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 December 19, 2017, bosutinib (Bosulif) was granted...
Why Right-to-Try Laws Are Dangerous
Why wouldn’t you support a patient with a terminal illness the “right to try” any therapy that may save his or her life? The answer to this question—one engulfed in a political debate in Congress—seems simple. It is not. [Editor’s Note: On May 30, 2018, the President signed into law the Trickett...
Larotrectinib in TRK Fusion–Positive Cancers in Adults and Children
In a study reported in The New England Journal of Medicine, Drilon et al found that the oral tropomyosin receptor kinase (TRK) inhibitor larotrectinib produced a high response rate and enduring responses in patients with TRK fusion–positive cancers. These fusions have been found to lead to...
Combination Immunotherapy in DNA Mismatch Repair–Deficient/Microsatellite Instability–High Metastatic Colorectal Cancer
As reported in the Journal of Clinical Oncology by Overman et al, findings in the nivolumab (Opdivo) plus ipilimumab (Yervoy) cohort of the CheckMate-142 study indicate a high response rate and durable responses with the combination in previously treated patients with DNA mismatch...
Pembrolizumab Active in Thymic Carcinoma
In a single-center phase II study reported in The Lancet Oncology, Giaccone et al found that pembrolizumab (Keytruda) produced durable responses in patients with recurrent thymic carcinoma. Study Details In the study, 40 evaluable patients with advanced disease progressing after at least one line ...
Pembrolizumab in MSI-H or dMMR Solid Tumors: ‘First Tissue/Site-Agnostic’ Approval by FDA
On May 23, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors progressing following prior treatment and who have no...
FDA Approves Lutetium Lu-177 Dotatate for Treatment of Gastroenteropancreatic Neuroendocrine Tumors
On January 26, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radiopharmaceutical has been approved for the treatment of GEP-NETs. Lu-177 dotatate is...
Pembrolizumab in Advanced Urothelial Carcinoma
On May 18, 2017, pembrolizumab (Keytruda) was granted regular approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...
Ceritinib in ALK-Positive Metastatic Non–Small Cell Lung Cancer
On May 26, 2017, ceritinib (Zykadia) was granted regular approval for treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by a U.S. Food and Drug Administration–approved test.1,2 In 2014, the drug received ...
Triple Inhibitory Neoadjuvant Therapy in HER2-Positive, ER-Positive Breast Cancer
In an Italian phase II study reported in The Lancet Oncology, Gianni et al found that neoadjuvant therapy with the RB1 inhibitor palbociclib (Ibrance), estrogen receptor (ER) inhibitor fulvestrant (Faslodex), and human epidermal growth factor receptor 2 (HER2) inhibitors trastuzumab (Herceptin) and ...
Alectinib in ALK-Positive Metastatic Non–Small Cell Lung Cancer
On November 6, 2017, alectinib (Alecensa) received regular approval for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration–approved test.1,2 Supporting Efficacy Data Approval was...
Gemtuzumab Ozogamicin in CD33-Positive Acute Myeloid Leukemia
On September 1, 2017, gemtuzumab ozogamicin (Mylotarg) was approved for treatment for newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients aged ≥ 2 years.1,2 It may be used in combination...
Bosutinib for First-Line Use in Chronic Myeloid Leukemia: Is Three a Crowd?
BOSUTINIB ( BOSULIF) is the latest tyrosine kinase inhibitor that has shown a superior molecular response profile when compared with imatinib.1,2 An orally available dual SRC/ABL1 inhibitor, the drug was shown in preclinical studies to have a potent inhibitory activity against BCR-ABL1 and minimal ...
Bosutinib Improves Response Rate vs Imatinib as First-Line Treatment of Chronic Myeloid Leukemia
IN THE PHASE III BFORE trial reported in the Journal of Clinical Oncology by Jorge E. Cortes, MD, of The University of Texas MD Anderson Cancer Center, and colleagues, the SRC/ABL kinase inhibitor bosutinib (Bosulif) improved response rates vs imatinib in the first-line treatment of patients with...
FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib (Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have received...
Nivolumab in Hepatocellular Carcinoma Previously Treated With Sorafenib
ON SEPTEMBER 22, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of hepatocellular carcinoma in patients previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS based on findings in a 154-patient subgroup of the CheckMate 040 trial consisting...
Pembrolizumab in Advanced Gastric Cancer
On September 22, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma with tumors expressing programmed cell death ligand 1 (PD-L1), as determined by a U.S. Food and Drug...
Abemaciclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
On September 28, 2017, the cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor abemaciclib (Verzenio) was approved for use in combination with fulvestrant (Faslodex) for women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following...
Comparison of First-Line Treatments in Chronic Myeloid Leukemia
In the phase III BFORE trial reported in the Journal of Clinical Oncology by Cortes et al, the SRC/ABL kinase inhibitor bosutinib (Bosulif) improved response rates vs imatinib in first-line treatment of patients with Philadelphia chromosome (Ph)-positive chronic phase chronic myeloid leukemia (CML) ...
ARIEL3 Investigators Clarify the Effects of Rucaparib on the Liver
PRIMARY RESULTS from the randomized, placebo-controlled, phase III study ARIEL3—presented at the European Society for Medical Oncology (ESMO) 2017 Congress and published recently in The Lancet1—demonstrated that maintenance treatment with the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib ...
Dacomitinib Prolongs Progression-Free Survival vs Gefitinib in First-Line Treatment of EGFR-Mutant NSCLC
THE PHASE III ARCHER 1050 trial has shown superior progression-free survival with the second-generation irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor dacomitinib vs gefitinib (Iressa) in the first-line treatment of advanced EGFR-mutant non–small-cell lung cancer...
Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
ON JULY 31, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of patients 12 years and older with DNA mismatch repair–deficient (dMMR) and microsatellite instability– high (MSI-H) metastatic colorectal cancer progressing following treatment with a fluoropyrimidine,...
Nivolumab in Advanced DNA Mismatch Repair–Deficient or Microsatellite Instability–High Colorectal Cancer
THE PHASE II CHECKMATE 142 TRIAL has shown that nivolumab (Opdivo) produces durable responses in previously treated recurrent or metastatic DNA mismatch repair–deficient (dMMR)/ microsatellite instability–high (MSI-H) colorectal cancer. These study findings were reported in The Lancet Oncology...
Comparison of First-Line Treatments for EGFR-Mutant NSCLC
The phase III ARCHER 1050 trial has shown superior progression-free survival with the second-generation irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor dacomitinib vs gefitinib (Iressa) in the first-line treatment of advanced EGFR-mutant non–small cell lung...
Nivolumab Approved in Japan for Unresectable Advanced or Recurrent Gastric Cancer That Has Progressed After Chemotherapy
On September 22, Bristol-Myers Squibb Company announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) approved nivolumab (Opdivo) for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. This approval was based on the phase III ...
Avelumab in Locally Advanced or Metastatic Urothelial Carcinoma
In the Clinic provides overviews of novel 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 May 9, 2017, avelumab (Bavencio) was granted...
Durvalumab in Advanced Urothelial Carcinoma Progressing After Platinum Therapy
In the Clinic provides overviews of novel 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 May 1, 2017, durvalumab (Imfinzi) was granted...
Combination Therapy for Previously Untreated BRAF V600E–Mutant Metastatic NSCLC
In a phase II trial, the combination of dabrafenib (Tafinlar) plus trametinib (Mekinist) produced durable responses in a cohort of patients with previously untreated BRAF V600E–mutant metastatic non–small cell lung cancer (NSCLC). The findings were reported in The Lancet Oncology by...
Adjuvant Therapy for Localized or Locally Advanced Renal Cell Carcinoma
As reported in the Journal of Clinical Oncology by Motzer et al, the phase III PROTECT trial showed no significant disease-free survival benefit for adjuvant pazopanib at 600 mg vs placebo after nephrectomy in patients with localized or locally advanced renal cell carcinoma at high risk of relapse. ...
Regorafenib in Hepatocellular Carcinoma Previously Treated With Sorafenib
On April 27, 2017, the indications for regorafenib (Stivarga) were expanded to include treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data The new approval was based on the finding of improved overall survival...
Pembrolizumab in Classical Hodgkin Lymphoma
On March 14, 2017, pembrolizumab (Keytruda) was granted accelerated approval for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma or those who have relapsed after three or more prior lines of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
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)...
Combination of Buparlisib and Fulvestrant in Postmenopausal Women With Advanced Breast Cancer
In the phase III BELLE-2 trial, the addition of the PI3K inhibitor buparlisib to fulvestrant (Faslodex) improved progression-free survival in postmenopausal hormone receptor–positive, HER2-negative advanced breast cancer—but at the cost of excessive toxicity. Results were reported in...
Combination Therapy With Pembrolizumab in Metastatic Nonsquamous NSCLC
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 May 10, 2017, pembrolizumab (Keytruda) was granted accelerated...
ALEX Trial: Alectinib vs Crizotinib in Untreated Advanced ALK-Positive NSCLC
As reported at the recent ASCO Annual Meeting and in The New England Journal of Medicine by Peters et al, the phase III ALEX trial has shown improvement in progression-free survival with alectinib (Alecensa) vs crizotinib (Xalkori) in the first-line treatment of advanced ALK-positive...
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 ...
Nivolumab in Urothelial Carcinoma After Platinum Therapy
On February 2, 2017, nivolumab (Opdivo) was granted accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant...
Ribociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
On March 13, the cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali) was approved for use in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast ...
Markedly Improved Progression-Free Survival With First-Line Ceritinib vs Platinum Chemotherapy in ALK-Rearranged NSCLC
In the phase III ASCEND-4 trial reported in The Lancet, Jean-Charles Soria, MD, of Institut Gustave Roussy, and colleagues found that ceritinib (Zykadia) improved progression-free survival vs platinum-based chemotherapy in the first-line treatment of advanced anaplastic lymphoma kinase...
Can Histone Deacetylase Inhibitors Reverse Resistance to Angiogenesis Inhibitors?
In a phase I study reported in the Journal of Clinical Oncology, Aggarwal et al found evidence that the histone deacetylase (HDAC) inhibitor abexinostat may act to reverse resistance to the vascular endothelial growth factor (VEGF) inhibitor pazopanib (Votrient) via epigenetic modulation of VEGF in ...
Phase III Trial Finds First-Line Ceritinib Improves PFS vs Platinum-Based Chemotherapy in ALK-Rearranged NSCLC
In a phase III trial (ASCEND-4) reported in The Lancet, Soria et al found that ceritinib (Zykadia) improved progression-free survival vs platinum-based chemotherapy in first-line treatment of advanced ALK-rearranged non–small cell lung cancer (NSCLC). Ceritinib is a next-generation selective...
