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Lung Cancer
Immunotherapy

Maintenance Bevacizumab With or Without Pemetrexed in Advanced Nonsquamous NSCLC

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)...

Leukemia
Immunotherapy

Expert Point of View: Howard J. Weinstein, MD

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...

Immunotherapy
Leukemia

Blinatumomab Outperforms Chemotherapy as Post-Reinduction Consolidation Therapy in Younger Patients With B-Cell ALL

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...

Skin Cancer
Immunotherapy

Different Doses of Adjuvant Ipilimumab vs High-Dose Interferon Alfa-2b in Patients With Resected High-Risk Melanoma

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...

Hematologic Malignancies
Immunotherapy

Preliminary Data on Multiantigen-Targeted CAR NK-Cell Therapy for B-Cell Malignancies

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 ...

Gynecologic Cancers
Immunotherapy

Addition of Olaparib to Bevacizumab Maintenance in Patients With Advanced Ovarian Cancer Responding to First-Line Therapy

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...

Lymphoma
Immunotherapy

Noninferiority of Four vs Six Cycles of CHOP for Patients With Favorable Prognosis B-Cell Lymphoma: FLYER Trial

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...

Bladder Cancer
Immunotherapy

FDA Approves PD-1 Inhibitor for BCG-Unresponsive, High-Risk Non–Muscle Invasive Bladder Cancer

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...

Solid Tumors
Lymphoma
Immunotherapy

Is Pembrolizumab Active in Pediatric Patients With PD-L1–Positive Advanced Solid Tumors or Lymphoma?

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...

Lung Cancer
Immunotherapy

Pembrolizumab in KRAS-Mutant and Wild-Type PD-L1–Positive Nonsquamous NSCLC

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...

Bladder Cancer
Immunotherapy

JAVELIN Bladder 100 Study of Avelumab for Urothelial Cancer Meets Primary Endpoint

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...

Multiple Myeloma
Immunotherapy

Overall Survival With the Addition of Daratumumab to VMP in Newly Diagnosed, Transplant-Ineligible Multiple Myeloma

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...

Lymphoma
Immunotherapy

Rituximab-abbs: Biosimilar to Rituximab for Non-Hodgkin Lymphoma

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...

Lymphoma
Immunotherapy

KEYNOTE-013 and KEYNOTE-170: Improving the Precision of Checkpoint Blockade in Patients With Diffuse Large B-Cell Lymphoma

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...

Lymphoma
Immunotherapy

Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma: KEYNOTE-013 and KEYNOTE-170

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...

Head and Neck Cancer
Immunotherapy

Pembrolizumab vs Cetuximab Plus Chemotherapy in Recurrent or Metastatic Head/Neck Squamous Cell Cancer

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...

Lung Cancer
Bladder Cancer
Colorectal Cancer
Hematologic Malignancies
Myelodysplastic Syndromes
Breast Cancer
Head and Neck Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in SCLC, Bladder Cancer, Colorectal Cancer

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 ...

Leukemia
Immunotherapy

Fractionated Tisagenlecleucel Infusion for Adults With B-Cell Acute Lymphoblastic Leukemia May Improve Safety Without Reducing Efficacy

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...

Solid Tumors
Immunotherapy

Nivolumab for Mismatch Repair–Deficient Noncolorectal Cancers

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...

Immunotherapy
Multiple Myeloma

Phase Ib/II Studies Explore Next-Generation BCMA-Targeted CAR T-Cell Therapies in Multiple Myeloma

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...

Immunotherapy
Lung Cancer

ESMO Immuno-Oncology 2019: Safety Analysis Results for First-Line Durvalumab Plus Platinum/Etoposide in Extensive-Stage SCLC

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...

Hepatobiliary Cancer
Immunotherapy

Does Second-Line Pembrolizumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib Confer a Survival Benefit?

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...

Prostate Cancer
Immunotherapy

Pembrolizumab in Refractory Metastatic Castration-Resistant Prostate Cancer

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 ...

Breast Cancer
Immunotherapy

First-Line Atezolizumab Plus Nab-paclitaxel in Advanced Triple-Negative Breast Cancer: Second Overall Survival Interim Analysis

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
Immunotherapy

Lung Cancer Expert Julie R. Brahmer, MD, MSc, Was an Early Believer in Immunotherapy—and Still Is

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 ...

Head and Neck Cancer
Immunotherapy

Immunotherapy for Head/Neck Squamous Cell Carcinoma: Questions Raised by KEYNOTE-048

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...

Immunotherapy
Lung Cancer

ESMO Immuno-Oncology 2019: First-Line Immunotherapy Combination for Patients With Advanced NSCLC and Comorbidities or Poor Performance Status

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...

Immunotherapy
Pancreatic Cancer

ESMO Immuno-Oncology 2019: CXCR4 Inhibitor in Combination With Pembrolizumab/Chemotherapy for Metastatic Pancreatic Cancer

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...

Gynecologic Cancers
Immunotherapy

ESMO Immuno-Oncology 2019: Sitravatinib/Tislelizumab Shows Antitumor Activity in Ovarian Cancer

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...

breast cancer
immunotherapy

Luca Gianni, MD, on the Neoadjuvant Treatment of Triple-Negative Breast Cancer

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).

breast cancer
immunotherapy

Ariella B. Hanker, PhD, on Therapeutic Implications of HER2 and HER3 Mutations in Breast Cancer

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).

breast cancer
immunotherapy

Hope S. Rugo, MD, on HER2-Positive Metastatic Breast Cancer: SOPHIA Trial of Chemotherapy Plus Margetuximab or Trastuzumab

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).

breast cancer
immunotherapy

Ralph R. Weichselbaum, MD, on Oligometastatic Cancer: The Role of Radioimmunotherapy

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).

breast cancer
immunotherapy

Sara M. Tolaney, MD, MPH, on HER2-Positive Breast Cancer: ATEMPT Trial on T-DM1 vs Paclitaxel Plus Trastuzumab

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).

Breast Cancer
Immunotherapy

SABCS 2019: Does Treatment With Pembrolizumab Improve Pathologic Complete Response in Patients With Triple-Negative Breast Cancer and Lymph Node Involvement?

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...

multiple myeloma
immunotherapy

Saad Z. Usmani, MD, on Carfilzomib, Dexamethasone, and Daratumumab for Relapsed or Refractory Myeloma

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).

leukemia
immunotherapy

Jeff P. Sharman, MD, on CLL: Trial Results on Acalabrutinib, Obinutuzumab, and Chlorambucil

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).

multiple myeloma
immunotherapy

C. Ola Landgren, MD, PhD, on Carfilzomib, Lenalidomide, Dexamethasone, and Daratumumab for Newly Diagnosed Multiple Myeloma

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).

leukemia
immunotherapy

Patrick A. Brown, MD, on B-Cell ALL in Children, Adolescents, and Young Adults: Blinatumomab vs Chemotherapy

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).

lymphoma
immunotherapy

Catherine M. Diefenbach, MD, on Follicular Lymphoma: Polatuzumab Vedotin Plus Obinutuzumab/Lenalidomide

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).

Leukemia
Immunotherapy

ASH 2019: Blinatumomab vs Standard Chemotherapy for Pediatric Patients With Relapsed B-ALL

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)....

Immunotherapy

Antibiotics and Immune Checkpoint Blockade in Patients With Cancer: First Do No Harm

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...

Immunotherapy

Prior Antibiotic Treatment Linked to Poorer Outcomes With Immunotherapy in Patients With Cancer

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...

multiple myeloma
sarcoma
immunotherapy

Edward A. Stadtmauer, MD, on Advanced Multiple Myeloma and Sarcoma: First-in-Human Assessment of CRISPR-Edited T Cells

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).

Immunotherapy
Lymphoma
Geriatric Oncology

ASH 2019: CAR T-Cell Therapy Shows Activity, Reduces Health-Care Utilization in Older Patients With DLBCL

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...

Multiple Myeloma
Immunotherapy

ASH 2019: Dose-Climbing Trial of Dual-Target CAR T-Cell Therapy for Relapsed or Refractory Multiple Myeloma

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...

Multiple Myeloma
Immunotherapy

ASH 2019: Phase Ib/II Study of BCMA-Directed CAR T-Cell Therapy for Pretreated Multiple Myeloma

Patients with multiple myeloma who had received a median of five prior therapies with refractory disease had a high response rate when treated with the investigational chimeric antigen receptor (CAR) T-cell therapy JNJ-4528, which targets B-cell maturation antigen (BCMA), a protein commonly found...

Hematologic Malignancies
Immunotherapy

ASH 2019: CAR-NK Therapy for B-Cell Malignancies Shows Activity in Preclinical Studies

Preclinical studies have provided the first evidence that cellular immunotherapy for B-cell cancers could ultimately become an off-the-shelf product, capable of being uniformly manufactured in large quantities. The product—FT596—is among the first cellular immunotherapies to be based on...

Immunotherapy
Lymphoma

ASH 2019: Early Data Signal Potential for Bispecific Antibody in Non-Hodgkin Lymphoma

The investigational bispecific antibody mosunetuzumab is showing activity in preliminary studies of patients with non-Hodgkin lymphoma (NHL), including those who are refractory to or relapsed after third-line chimeric antigen receptor (CAR) T-cell therapy. If preliminary findings are validated by...

Breast Cancer
Immunotherapy

Promising New Treatments for Triple-Negative Breast Cancer: Immunotherapy and Other Targeted Therapies

Clinical trials continue to demonstrate that combining immunotherapy with chemotherapy and other targeted therapies can improve survival for patients with triple-negative breast cancer, according to results presented at the 21st Annual Lynn Sage Breast Cancer Symposium in Chicago. Nearly 700...

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