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kidney cancer
immunotherapy

FDA Approves Pembrolizumab Plus Axitinib for First-Line Treatment of Advanced Renal Cell Carcinoma

On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYNOTE-426 Approval was based on KEYNOTE-426, a randomized, multicenter, open-label trial conducted in ...

lung cancer
immunotherapy

KEYNOTE-042: Pembrolizumab vs Chemotherapy in Previously Untreated Locally Advanced or Metastatic NSCLC With PD-L1 Expression ≥ 1%

As reported in The Lancet by Mok et al, the KEYNOTE-042 trial has shown an improvement in overall survival with pembrolizumab vs standard chemotherapy in previously untreated patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) without a sensitizing EGFR mutation or ...

gynecologic cancer
immunotherapy

KEYNOTE-158: Pembrolizumab in Previously Treated Advanced Cervical Cancer

As reported in the Journal of Clinical Oncology by Chung et al, the phase II KEYNOTE-158 trial showed activity of pembrolizumab in previously treated programmed cell death ligand 1 (PD-L1)-positive advanced cervical cancer. The study supported the 2018 accelerated approval of pembrolizumab in this...

lung cancer
immunotherapy

FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting

Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC....

lung cancer
immunotherapy

ELCC 2019: Does Maintenance Immunotherapy Improve Survival in Patients With Advanced SCLC?

Maintenance immunotherapy did not improve survival in patients with extensive-stage small cell lung cancer (SCLC), according to late-breaking results from the CheckMate 451 study presented today by Owonikoko et al at the European Lung Cancer Congress 2019 (Abstract LBA1_PR). Around 60% to 70% of...

lung cancer
issues in oncology
immunotherapy

ELCC 2019: Immunotherapy in Elderly Patients With Advanced NSCLC

Two studies reported at the European Lung Cancer Congress (ELCC) 2019 provided new insights on the efficacy and safety of immunotherapy in elderly patients with advanced non–­small cell lung cancer (NSCLC). Although around half of all people newly diagnosed with NSCLC are elderly (Pallis ...

Breast Cancer
Immunotherapy

Expert Point of View: Kunle Odunsi, MD, PhD

THE DISCUSSANT of the abstract was Kunle Odunsi, MD, PhD, Cancer Center Deputy Director, Chair of the Department of Gynecologic Oncology, and Executive Director of the Center for Immunotherapy, at Roswell Park Comprehensive Cancer Center, Buffalo, New York. He emphasized the large number of...

Breast Cancer
Immunotherapy

Vaccine Plus Trastuzumab in Preventing Recurrence of HER2–Low-Expressing Breast Cancer

IN HIGH-RISK patients with breast cancer and low expression of HER2 (HER2 low), a peptide vaccine targeting HER2, combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), and given concurrently with trastuzumab, may help to prevent recurrence. Final analysis of a randomized phase...

Immunotherapy

Expert Point of View: Michael Morse, MD

FORMAL DISCUSSANT of the abstract presented by Harding et al, Michael Morse, MD, Professor of Medicine at Duke University Medical Center, in Durham, North Carolina, noted that the authors should be commended on a complex dose-escalation strategy that surely required a lot of collaboration among...

Immunotherapy

The Future of Immunotherapy: Building on Checkpoint Blockade

THE EMERGENCE of anticancer agents that block immune checkpoints has transformed the field of oncology, leading to durable responses and improvements in overall survival in melanoma, renal cell carcinoma, head/neck squamous cell carcinoma, urothelial bladder cancer, and non–small cell lung cancer....

Immunotherapy

Anti–TIM-3 Antibody Well Tolerated as Monotherapy and in Combination With Anti–PD-L1 Antibody

INITIAL DATA from the ongoing, multicenter, first-in-human, phase Ia/Ib dose-escalation and -expansion study suggest that an anti–T-cell immunoglobulin domain and mucin domain–containing molecule 3 (anti–TIM-3) antibody alone or in combination with immune checkpoint blockade could counter intrinsic ...

Bladder Cancer
Immunotherapy

Lenvatinib Plus Pembrolizumab Shows Activity in Advanced Urothelial Cancer

THE COMBINATION of lenvatinib plus pembrolizumab has demonstrated antitumor activity in patients with advanced urothelial cancer, including patients receiving later-line treatment. Results of a phase Ib/II trial showed an objective response rate of 25% and a median progression-free survival of 5.4...

Immunotherapy
Pancreatic Cancer

VISTA Checkpoint Implicated in Pancreatic Cancer Immunotherapy Resistance

Researchers have identified a new potential immunotherapy target in pancreatic cancer, which so far has been notoriously resistant to treatment with immune checkpoint blockade drugs effective against a variety of other cancers. A research team from The University of Texas MD Anderson Cancer Center...

Hematologic Malignancies
Immunotherapy

Allogeneic Hematopoietic Cell Transplantation and Cell Therapy

As part of The ASCO Post’s continued coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, here is an update on several studies of allogeneic hematopoietic cell transplantation (allo-HCT) and cellular therapy, as used in myelodysplastic syndromes (MDS), acute...

Kidney Cancer
Immunotherapy

Expert Point of View: Tracy Rose, MD, MPH

THE FORMAL DISCUSSANT of the KEYNOTE-427 trial, Tracy Rose, MD, MPH, of the University of North Carolina, Chapel Hill, told listeners: “I think pembrolizumab should now be considered an option for non–clear cell kidney cancer. Response rates, however, remain inferior to those seen in clear cell...

Kidney Cancer
Immunotherapy

Study Finds Pembrolizumab Active in Advanced Non–Clear Cell Kidney Cancer

IMMUNOTHERAPY WITH the checkpoint inhibitor pembrolizumab may prove to be an effective option for patients with advanced non–clear cell renal cell carcinoma, according to results in cohort B of the KEYNOTE-427 trial, presented at the 2019 Genitourinary Cancers Symposium.1 Response rates were...

Prostate Cancer
Immunotherapy

Nivolumab Combined With Ipilimumab Shows Activity in Prostate Cancer Subsets

In contrast with melanoma, lung cancer, and kidney cancer, immune checkpoint inhibitor therapy has been disappointing in prostate cancer thus far. Because of success in treating other tumor types, interest remains high in exploring the effect of immunotherapy with checkpoint inhibition in prostate...

Prostate Cancer
Immunotherapy

CheckMate 650: Nivolumab and Ipilimumab in Metastatic, Castration-Resistant Prostate Cancer

SOME PATIENTS with metastatic prostate cancer may respond to a combination of immune checkpoint inhibitors after treatment with hormonal therapy and chemotherapy is not successful, according to early results from the phase II CheckMate 650 trial. Principal Investigator Padmanee Sharma, MD, PhD,...

Kidney Cancer
Immunotherapy

CALYPSO: Savolitinib Plus Durvalumab in Metastatic Papillary Renal Cell Carcinoma

THE COMBINATION of savolitinib and durvalumab achieved durable responses in approximately one-fourth of patients with metastatic papillary renal cell carcinoma in the phase II CALYPSO study.1 Treatment options are limited for papillary renal cell carcinoma. Clinical guidelines recommend enrollment...

Kidney Cancer
Immunotherapy

Pembrolizumab/Cabozantinib Shows Activity in Previously Treated Renal Cell Carcinoma

THE COMBINATION of pembrolizumab and cabozantinib demonstrated antitumor activity in patients with previously treated metastatic renal cell carcinoma and both drugs were tolerable at their approved doses, according to data from a dose-escalation cohort of a phase I study.1 Among eight patients with ...

Kidney Cancer
Immunotherapy

Nivolumab/Ipilimumab in Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma

NIVOLUMAB PLUS low-dose ipilimumab continued to demonstrate strong responses as well as a survival benefit with a median of 32.4 months of follow-up as front-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma, according to an update of the phase II CheckMate...

Kidney Cancer
Immunotherapy

JAVELIN Renal 101: Avelumab Plus Axitinib vs Sunitinib in the First-Line Treatment of Advanced Kidney Cancer

THE PROGRAMMED cell death-ligand 1 (PD-L1) inhibitor, avelumab, was combined with the multitargeted vascular growth endothelial factor (VEGF) agent, axitinib, and compared to monotherapy with sunitinib in the first-line treatment of patients with metastatic renal cell carcinoma. Toni K. Choueiri,...

Kidney Cancer
Immunotherapy

Expert Point of View: Lori Wood, MD

LORI WOOD, MD, of Dalhousie University in Halifax, Nova Scotia, Canada was the formal discussant for the KEYNOTE 426 study presented at the 2019 Genitourinary Cancers Symposium.1,2 Dr. Wood called the KEYNOTE 426 phase III trial “practice-changing,” and added, “The majority of patients with...

Kidney Cancer
Immunotherapy

KEYNOTE 426: Pembrolizumab Plus Axitinib vs Sunitinib in First-Line Therapy for Advanced Renal Cell Carcinoma

AS REPORTED at the 2019 Genitourinary Cancers Symposium by Thomas Powles, MD, and as published in The New England Journal of Medicine by Brian Rini, MD, and colleagues, significant benefits in overall and progression-free survival were achieved with the combination of pembrolizumab plus axitinib...

gynecologic cancer
immunotherapy

Lenvatinib Plus Pembrolizumab in Advanced Endometrial Cancer

In an interim analysis of a phase II study reported in The Lancet Oncology, Makker et al found that lenvatinib plus pembrolizumab was active in advanced endometrial cancer. Study Details In the study, 54 patients from 11 sites with metastatic endometrial cancer unselected for microsatellite...

lymphoma
immunotherapy

AUGMENT: Addition of Lenalidomide to Rituximab in Relapsed or Refractory Indolent Lymphoma

In the phase III AUGMENT trial reported in the Journal of Clinical Oncology, Leonard et al found that the addition of lenalidomide to rituximab significantly prolonged progression-free survival in patients with relapsed or refractory indolent lymphoma. Study Details The double-blind trial...

colorectal cancer
immunotherapy

BEACON Colorectal Cancer Trial: Safety Lead-in With Triplet Therapy for BRAF V600E–Mutant Metastatic Disease

As reported in the Journal of Clinical Oncology by Van Cutsem et al, treatment with encorafenib, binimetinib, and cetuximab for BRAF V600E–mutant metastatic colorectal cancer was associated with a manageable safety profile and evidence of activity in the safety lead-in to the phase III BEACON ...

skin cancer
immunotherapy

AACR 2019: Entinostat Plus Pembrolizumab in Patients With Melanoma Previously Treated With Anti–PD-1 Therapy

A combination of the experimental histone deacetylase (HDAC) inhibitor entinostat with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab showed clinical responses in patients with melanoma that had progressed on prior anti–PD-1 treatment, according to results from the phase...

pancreatic cancer
immunotherapy

AACR 2019: CD40 Antibody Combined With Chemotherapy in Advanced Pancreatic Cancer

An interim analysis of a small phase Ib study by O’Hara et al evaluating the CD40 agonistic monoclonal antibody APX005M in combination with gemcitabine and nab-paclitaxel with or without the programmed cell death protein 1 (PD-1) inhibitor nivolumab in untreated patients with metastatic...

lung cancer
immunotherapy

AACR 2019: Data Analysis Shows Activity of Pembrolizumab in Pretreated Patients With Advanced Small Cell Lung Cancer

The results of an analysis of pooled data from the phase Ib KEYNOTE-028 trial and the phase II KEYNOTE-158 study of the anti–programmed cell death protein 1 monoclonal antibody pembrolizumab in the treatment of advanced small cell lung cancer has found that the therapy provided antitumor...

sarcoma
immunotherapy

AACR 2019: HER2-Targeted CAR T-Cell Therapy Plus Chemotherapy in Advanced Sarcoma

A small phase I study by Navai et al investigated a combination of lymphodepletion chemotherapy and HER2-specific chimeric antigen receptor (CAR) T-cell therapy for pediatric and adult patients with advanced HER2-positive sarcoma. The combination showed promising antitumor activity and was found to ...

Multiple Myeloma
Immunotherapy

Expert Point of View: Ajay K. Nooka, MD, MPH

THE ASCO POST asked Ajay K. Nooka, MD, MPH, Associate Professor, Division of Bone Marrow Transplant at Winship Cancer Institute, Emory University, to comment on studies involving daratumumab. “After the phase III SWOG S0777 trial demonstrated a survival benefit with a 3-drug induction regimen...

Immunotherapy
Multiple Myeloma

ASH Reports Show Benefit of Adding Daratumumab to Initial Therapy in Multiple Myeloma

DARATUMUMAB APPEARS to be the “gift that keeps on giving” to the myeloma community. “It seems we can add daratumumab to almost anything and make the regimen better. It’s got good activity and a good safety profile,” said Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt...

Breast Cancer
Immunotherapy

Expert Point of View: Matthew P. Goetz, MD

“WHAT’S IMPORTANT for clinicians to take away from this analysis is that there is clearly zero benefit of atezolizumab/nab-paclitaxel in patients with programmed cell death ligand 1 (PD-L1)-negative disease. In PD-L1–positive patients, the combination improves progression-free survival and overall ...

Breast Cancer
Immunotherapy

IMpassion130 Substudy: Atezolizumab/Nab-Paclitaxel Survival Benefits Limited to PD-L1–Positive Triple-Negative Breast Cancer

THE PHASE III IMpassion130 trial, first reported at the European Society for Medical Oncology (ESMO) 2018 Congress1 and published in The New England Journal of Medicine,2 found that the combination of front-line atezolizumab plus nab-paclitaxel significantly improved disease-free and overall...

Breast Cancer
Immunotherapy

FDA Grants Accelerated Approval to Atezolizumab/ Nab-paclitaxel in Triple-Negative Breast Cancer

ON MARCH 8, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, PD-L1–positive triple-negative breast cancer. PD-L1 status is determined by...

Issues in Oncology
Immunotherapy

Expert Point of View: Jason Luke, MD, FACP

DISCUSSANT OF the abstract presented by Pinato et al, Jason Luke, MD, FACP, Assistant Professor of Medicine at the University of Chicago Comprehensive Cancer Center, called the survival difference for patients receiving antibiotics prior to checkpoint blockade “rather dramatic and quite...

Issues in Oncology
Immunotherapy

Antibiotic Treatment Prior to Immune Checkpoint Inhibitor Therapy Shows Detrimental Effect on Response and Survival

USE OF ANTIBIOTICS prior to checkpoint blockade therapy may attenuate anticancer activity, according to data presented at the 2019 ASCO–Society for Immunotherapy of Cancer (SITC) Clinical Immuno-Oncology Symposium.1 Results of the multicenter study suggest that antibiotic therapy administered...

Lung Cancer
Immunotherapy

Expert Point of View: Siwen Hu-Lieskovan, MD, PhD

DISCUSSANT OF the CheckMate 384 trial, Siwen Hu-Lieskovan, MD, PhD, Director of Solid Tumor Immunotherapy at the Huntsman Cancer Institute, University of Utah, called the short-term safety data “convincing.” However, she noted that the long-term impact of intermittent, lower-minimum concentration...

Lung Cancer
Immunotherapy

CheckMate 384 Supports More Convenient Dosing of Nivolumab in Advanced NSCLC

PATIENTS WITH advanced non–small cell lung cancer (NSCLC) may no longer have to come to the clinic every 2 weeks for treatment. According to a descriptive analysis of the phase IIIb/IV CheckMate 384 study, a more convenient dosing option of nivolumab has demonstrated convincing short-term safety...

colorectal cancer
immunotherapy

Pertuzumab Plus Trastuzumab in HER2-Amplified Metastatic Colorectal Cancer

As reported in The Lancet Oncology by Meric-Bernstam et al, the combination of pertuzumab and trastuzumab showed activity in HER2-amplified metastatic colorectal cancer in the phase IIa multiple basket study MyPathway. The study is evaluating activity of targeted therapies in nonindicated tumor...

skin cancer
immunotherapy

Immunotherapy Directed Against Precancerous Skin Lesions May Prevent Squamous Cell Carcinoma

A treatment previously shown to treat the precancerous skin lesions called actinic keratosis now appears to also reduce the chance that these pretreated lesions will develop into squamous cell carcinoma. In a report published by Rosenberg et al in JCI Insight, researchers found that treatment with...

kidney cancer
immunotherapy

Eric Jonasch, MD, on Kidney Cancer: A Year in Review

Eric Jonasch, MD, of The University of Texas MD Anderson Cancer Center, discusses major findings over the past 12 months in kidney cancer, including combination immunotherapies and trends in surgical oncology.

immunotherapy
lung cancer

Matthew A. Gubens, MD, on Non–Small Cell Lung Cancer: New Immunotherapy Strategies in the NCCN Guidelines

Matthew A. Gubens, MD, of the UCSF Helen Diller Family Comprehensive Cancer Center, discusses recent updates to the NCCN Guidelines in non–small cell lung cancer, including the use of pembrolizumab as a single agent or in combination based on PD-L1 status, treatment selection in squamous and nonsquamous patients, and how mutational status affects treatment strategy.

immunotherapy
leukemia
lymphoma

Frederick L. Locke, MD, on Innovative CAR-T Cell Therapies: The Patient Experience

Frederick L. Locke, MD, of the H. Lee Moffitt Cancer Center and Research Institute, discusses recent approvals of chimeric antigen receptor T-cell therapies in leukemia and lymphoma, and how clinicians are using infrastructure, navigation, and early referrals to maximize response and minimize toxicity.

lung cancer
immunotherapy

Jyoti D. Patel, MD, on Stage III Non–Small Cell Lung Cancer: A Look at New Systemic Treatments

Jyoti D. Patel, MD, of the University of Chicago, discusses immunotherapy for locally advanced NSCLC, selecting patients for these treatments, and the potential toxicities of combination therapies.

immunotherapy

Martin Edelman, MD, on Immunotherapy: How Safe Is It for Patients With Autoimmune Disease?

Martin Edelman, MD, of Fox Chase Cancer Center, discusses the limited retrospective data that indicate some patients with cancer and autoimmune disease (such as lupus or ulcerative colitis) can safely receive immunotherapy with checkpoint inhibitors.

lung cancer
immunotherapy

Ruqin Chen, MB, on Lung Cancer Treated With Immune Checkpoint Inhibitors: Survival Outcomes and Clinical and Molecular Features

Ruqin Chen, MB, of the Mayo Clinic Florida, discusses early study findings that show molecular profiling with NF1, CD79a, and AKT3 could potentially improve prediction of progression-free survival in patients with lung cancer who are receiving immunotherapy.

lung cancer
immunotherapy

Leora Horn, MD, on Small Cell Lung Cancer and Immuno-oncology: Have We Finally Solved the Small Cell Paradox?

Leora Horn, MD, of Vanderbilt University Medical Center, discusses the progress made treating extensive-stage small cell lung cancer, improvements in progression-free and overall survival, and the fact that it’s still difficult to determine which patients will benefit most from immunotherapy.

gynecologic cancer
immunotherapy

SGO 2019: Dendritic Cell–Based Immunotherapy in Combination With Chemotherapy in Recurrent Ovarian Cancer

Results from a clinical trial presented by Cibula et al at the Society of Gynecologic Oncology’s (SGO) 50th Annual Meeting on Women’s Cancer showed that a new immunotherapy treatment significantly prolongs survival in women with recurrent ovarian cancer when added to standard...

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