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The combination of brentuximab vedotin and nivolumab is making headway as first-line therapy for older adults with Hodgkin lymphoma and as salvage therapy for adults with relapsed or refractory classic Hodgkin lymphoma, according to separate studies presented at the 2019 Annual Meeting &...
In an analysis of the EORTC 1325/KEYNOTE-054 trial of adjuvant pembrolizumab vs placebo in stage III melanoma reported in JAMA Oncology, Alexander M.M. Eggermont, MD, PhD, and colleagues found that patients treated with pembrolizumab who experienced immune-related adverse events had improved...
The likelihood of a patient responding to immune checkpoint blockade may depend on B cells in the tumor, located within specialized immune-cell clusters known as tertiary lymphoid structures, according to three studies all recently published in Nature. The studies showed that enrichment of B cells...
This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for ovarian, prostate, and lung cancer; granted Orphan Drug designation to therapies for chemotherapy-induced thrombocytopenia and multiple myeloma; and granted Breakthrough Device designation to platforms...
In a Japanese phase III trial reported in the Journal of Clinical Oncology, Seto et al found that the addition of maintenance pemetrexed to bevacizumab did not significantly improve overall survival in patients with previously untreated, advanced nonsquamous non–small cell lung cancer (NSCLC)...
Commenting on the blinatumomab study, Howard J. Weinstein, MD, Chief of Pediatric Hematology-Oncology at Massachusetts General Hospital for Children and Harvard Medical School in Boston, said: “These are very promising results for children, adolescents, and young adults who have had a first...
Blinatumomab was superior to standard chemotherapy in children, adolescents, and young adults at the first relapse of B-cell acute lymphoblastic leukemia (ALL) as post-reinduction consolidation therapy prior to hematopoietic stem cell transplant (HSCT), according to the results of a late-breaking...
As reported in the Journal of Clinical Oncology by Tarhini et al, the phase III Intergroup E1609 trial has shown an overall survival advantage with adjuvant ipilimumab at 3 mg/kg—but not at 10 mg/kg—vs high-dose interferon alfa-2b in patients with resected high-risk cutaneous melanoma. The...
A novel off-the-shelf chimeric antigen receptor natural killer cell (CAR-NK) product called FT596 may prove to be an active therapy for B-cell malignancies. This agent is designed to overcome several challenges inherent in CAR T-cell therapy, including CD19-antigen escape, which leads to relapse in ...
As reported in The New England Journal of Medicine by Isabelle Ray-Coquard, MD, PhD, and colleagues, the phase III PAOLA-1 trial has shown a progression-free survival benefit with the addition of olaparib to bevacizumab maintenance in patients with advanced ovarian cancer responding to first-line...
As reported in The Lancet by Viola Poeschel, MD, and colleagues, the phase III FLYER trial has shown noninferiority of progression-free survival with four vs six cycles of cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP) in combination with six doses of rituximab in patients with...
Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have...
Interim analysis of the phase I/II KEYNOTE-051 trial, reported in The Lancet Oncology by Geoerger et al, indicated minimal activity of pembrolizumab in pediatric patients with programmed cell death ligand 1 (PD-L1)-positive advanced, relapsed, or refractory solid tumors; however, activity was...
In an analysis reported in Annals of Oncology, Roy S. Herbst, MD, PhD, and colleagues found that pembrolizumab was active in both KRAS-mutant and wild-type tumors in a subgroup of patients in the KEYNOTE-042 trial with programmed cell death ligand 1 (PD-L1)-positive nonsquamous non–small cell lung...
The phase III JAVELIN Bladder 100 trial met its primary endpoint of overall survival at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma whose disease did not progress on induction chemotherapy and who were randomly...
As reported in The Lancet by Maria-Victoria Mateos, MD, and colleagues, interim analysis of overall survival in the phase III ALCYONE trial has shown a significant benefit of the addition of daratumumab to bortezomib, melphalan, and prednisone (D-VMP) in patients with newly diagnosed multiple...
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. Late in 2018, rituximab-abbs was approved as the first...
Primary mediastinal B-cell lymphoma is an uncommon but distinct clinicopathologic variant of diffuse large B-cell lymphoma (DLBCL) that typically presents with an aggressive mediastinal mass and invasion of local structures. Most patients are young, typically in their 20s and 30s, and there is a...
Findings in the phase Ib KEYNOTE-013 and phase II KEYNOTE-170 trials, reported in the Journal of Clinical Oncology by Philippe Armand, MD, PhD, of DanaFarber Cancer Institute, and colleagues, indicate that pembrolizumab is active in relapsed or refractory primary mediastinal large B-cell...
As reported in The Lancet by Barbara Burtness, MD, of the Department of Medicine, Yale University School of Medicine, and colleagues, the phase III KEYNOTE-048 trial has shown improved overall survival with first-line pembrolizumab plus chemotherapy vs cetuximab plus chemotherapy among patients...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Reviews for treatments in extensive-stage small cell lung cancer (SCLC), non–muscle invasive bladder cancer, and BRAF V600E–mutant colorectal cancer. The Agency also recently issued multiple Breakthrough Therapy designations and ...
As reported by Noelle V. Frey, MD, and colleagues in the Journal of Clinical Oncology, single-center experience with the anti-CD19 chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel has shown that high-dose fractionated infusion with the ability to modify dosing in case of early signs...
In a study (NCI-MATCH trial subprotocol, arm Z1D) reported in the Journal of Clinical Oncology, Azad et al found that nivolumab was active in mismatch repair–deficient noncolorectal cancers. As stated by the investigators, “The National Cancer Institute Molecular Analysis for Therapy Choice...
In patients with relapsed or refractory multiple myeloma, two novel dual-target chimeric antigen receptor (CAR) T-cell strategies are yielding early and durable responses, with seemingly less cytokine-release syndrome and neurotoxicity than first-generation CAR T-cell products, according to the...
Few grade 3 or higher immune-related adverse events were observed in patients treated with first-line durvalumab plus platinum/etoposide for extensive-stage small cell lung cancer (SCLC), according to findings from the safety analysis of the phase III CASPIAN study presented by Özgüroğlu et al at...
As reported in the Journal of Clinical Oncology by Richard S. Finn, MD, and colleagues, the phase III KEYNOTE-240 trial has shown no statistically significant progression-free or overall survival benefit with pembrolizumab vs placebo in patients with advanced hepatocellular carcinoma who were...
In the phase II KEYNOTE-199 study, reported in the Journal of Clinical Oncology by Antonarakis et al, pembrolizumab showed activity and had an acceptable safety profile in patients with treatment-refractory metastatic castration-resistant prostate cancer. Study Details The trial was conducted at 85 ...
As reported in The Lancet Oncology by Peter Schmid, MD, and colleagues, the prespecified second interim analysis of overall survival in the phase III IMpassion130 trial has shown no overall survival benefit with the addition of atezolizumab to nab-paclitaxel as first-line treatment of unresectable, ...
Lung cancer specialist Julie R. Brahmer, MD, MSc, comes from a long line of Midwest farmers who still run a family operation. “I’m originally from what I would call the middle of nowhere in Nebraska. My father is a sixth-generation farmer, and my mother is a nurse. I was inclined toward medicine at ...
There is a new first-line treatment option for patients with newly diagnosed, recurrent, or metastatic head and neck squamous cell carcinoma. As reported by Burtness et al in The Lancet, pembrolizumab improved overall survival vs the standard-of-care regimen of cetuximab and platinum-based...
First-line treatment with the combination of nivolumab and ipilimumab was safe and provided encouraging overall survival results in patients with advanced non–small cell lung cancer (NSCLC), as well as in patients with NSCLC traditionally not eligible for clinical trials—such as those who had...
When the CXCR4 inhibitor BL-8040 was combined with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab plus chemotherapy in the second-line setting, the regimen showed promising antitumor activity in patients with metastatic pancreatic ductal adenocarcinoma. These findings were...
Results from a phase Ib study reported at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2019 showed manageable safety and encouraging antitumor activity in patients with advanced ovarian cancer treated with the novel combination of sitravatinib and tislelizumab. These...
Luca Gianni, MD, of the Fondazione Michelangelo, discusses findings from the NeoTRIP trial on pathologic complete response to neoadjuvant treatment with or without atezolizumab in triple-negative, early high-risk, and locally advanced breast cancer (Abstract GS3-04).
Ariella B. Hanker, PhD, of UT Southwestern Medical Center, discusses data showing that breast cancers expressing co-occurring HER2 and HER3 mutations may require the addition of a phosphoinositide 3-kinase alpha inhibitor to a HER2 tyrosine kinase inhibitor (Abstract GS6-04).
Hope S. Rugo, MD, of the University of California San Francisco Comprehensive Cancer Center, discusses trial data on margetuximab plus chemotherapy, which improved progression-free survival in patients with previously treated HER2-positive metastatic breast cancer when compared with trastuzumab plus chemotherapy. Maturing data comparing overall survival also provides new insights (Abstract GS1-02).
Ralph R. Weichselbaum, MD, of the University of Chicago, summarizes a plenary lecture in which he presented data that could guide future clinical strategies: studies supporting the basis and classification of oligometastatic disease, including breast cancer; and basic and clinical data on radioimmunotherapy (Abstract PL2).
Sara M. Tolaney, MD, MPH, of Dana-Farber Cancer Institute, discusses phase II findings on patients receiving T-DM1 monotherapy as adjuvant treatment for stage I HER2-positive breast cancer, a regimen associated with few recurrences in the study population (Abstract GS1-05).
The addition of the checkpoint inhibitor pembrolizumab to neoadjuvant chemotherapy and as adjuvant therapy increased the rates of pathologic complete response in patients with triple-negative breast cancer who had lymph node involvement, according to results from the KEYNOTE-522 trial, which were...
Saad Z. Usmani, MD, of the Levine Cancer Institute, discusses phase III study findings suggesting that the combination of carfilzomib/dexamethasone/daratumumab represents an efficacious new regimen for patients with relapsed or refractory disease, including those refractory to lenalidomide (Abstract LBA-6).
Jeff P. Sharman, MD, of the Willamette Valley Cancer Institute and US Oncology Research, discusses phase III findings from the ELEVATE TN study, which showed that acalabrutinib plus obinutuzumab and acalabrutinib monotherapy improved progression-free survival in patients with treatment-naive chronic lymphocytic leukemia (Abstract 31).
C. Ola Landgren, MD, PhD, of Memorial Sloan Kettering Cancer Center, discusses phase II study findings that showed an 83% negative rate of minimal residual disease in newly diagnosed multiple myeloma treated weekly with 8 cycles of the quadruplet regimen of carfilzomib/lenalidomide/dexamethasone/daratumumab, without autologous stem cell transplant (Abstract 862).
Patrick A. Brown, MD, of Johns Hopkins University, discusses phase III findings from a Children’s Oncology Group Study showing that blinatumomab was superior to chemotherapy in terms of efficacy and tolerability for young patients as a post-reinduction therapy in the setting of high- and intermediate-risk first relapse of B-cell acute lymphoblastic leukemia (Abstract LBA-1).
Catherine M. Diefenbach, MD, of the Perlmutter Cancer Center at NYU Langone, discusses a primary analysis of a phase Ib/II trial showing that the novel triplet combination of polatuzumab vedotin plus obinutuzumab/lenalidomide is safe and effective, with high complete response rates seen in a heavily pretreated and refractory population (Abstract 126).
Blinatumomab improved survival in children with relapsed B-acute lymphoblastic leukemia (B-ALL) compared with standard chemotherapy, accordings to findings from a study presented by Brown et al at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract LBA-1)....
Despite the unprecedented improvement in clinical outcomes with the advent of immune checkpoint blockade for cancer,1,2 robust biomarkers for therapeutic success as well as novel strategies to increase their efficacy are urgently needed. In addition to exploring novel immune checkpoints and other...
In a study presented in a brief report in JAMA Oncology,1 David J. Pinato, MD, PhD, of the Imperial College London, and colleagues found that past—but not concurrent—use of broad-spectrum antibiotic therapy was associated with poorer treatment outcomes in patients receiving immune checkpoint...
Edward A. Stadtmauer, MD, of the University of Pennsylvania Abramson Cancer Center, discusses phase I results of immune cells, modified with CRISPR/Cas9 technology, and infused in three patients (two with multiple myeloma and one with sarcoma). Researchers observed the cells expand and bind to their tumor targets with no serious side effects (Abstract 49).
A new analysis of Medicare claims data presented by Kilgore et al at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 793) has provided the first real-world evidence using claims data available after the approval of autologous anti-CD19 chimeric antigen...
More than three out of four patients with relapsed multiple myeloma, or myeloma that was refractory to at least two therapies, remained in remission 7 months after treatment with a novel chimeric antigen receptor (CAR) T-cell therapy targeting two proteins that are frequently found on myeloma...