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bladder cancer
immunotherapy

Thomas Powles, MD, PhD, on Metastatic Urothelial Cancer: Durvalumab Plus Targeted Treatments

Thomas Powles, MD, PhD, of Queen Mary University of London, discusses the first study to examine immunotherapy and targeted treatment combinations with a personalized approach in bladder cancer. FGF, TORC1/2, and PARP inhibitors were explored in combination with durvalumab in selected patients (Abstract 902O).

skin cancer
immunotherapy

Paolo A. Ascierto, MD, on Melanoma: Results From CheckMate 238 on Adjuvant Nivolumab vs Ipilimumab

Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori, Napoli, discusses phase III study findings confirming the superior activity of nivolumab vs ipilimumab in resected stage III/IV melanoma in terms of regression-free survival after a minimum follow-up of 36 months (Abstract 1310O).

Skin Cancer
Immunotherapy

ESMO 2019: 5-Year Survival and Response With Nivolumab/Ipilimumab in Advanced Melanoma

An update of results of the phase III CheckMate 067 trial at 5 years presented by Larkin et al at the European Society for Medical Oncology (ESMO) 2019 Congress showed that both nivolumab in combination with ipilimumab and nivolumab alone provided significant improvements in overall survival,...

Hepatobiliary Cancer
Immunotherapy

ESMO 2019: First-Line Immunotherapy Shows Clinical Benefit in Advanced Hepatocellular Carcinoma

New data have shown a trend toward clinically meaningful improvements in survival and response rates and a favorable safety profile with first-line immunotherapy compared to current standard treatment for advanced hepatocellular carcinoma (HCC). The data, reported by Yau et al at the European...

Immunotherapy
Issues in Oncology

Prior Antibiotic Treatment and Response to Immune Checkpoint Inhibitor Therapy in Patients With Cancer

In a study presented in a brief report in JAMA Oncology, Pinato et al found that past—but not concurrent—use of broad-spectrum antibiotic therapy was associated with poorer treatment outcomes in patients receiving immune checkpoint inhibitors for various cancers in routine clinical practice. As...

Skin Cancer
Immunotherapy

Treatment-Free Survival as an Outcome Measure of Nivolumab/Ipilimumab Therapy in Advanced Melanoma

In a pooled analysis reported in the Journal of Clinical Oncology, Regan et al evaluated treatment-free survival as an outcome measure among patients with advanced melanoma receiving nivolumab/ipilimumab or either agent alone in the CheckMate 067 and 069 trials. Study Details The study involved...

Immunotherapy

How Ultrahigh-Dose Radiation Therapy, Interferon, and CAR T Cells May Boost Immunotherapy Effectiveness

This past June, the University of Pennsylvania established the Mark Foundation Center for Immunotherapy, Immune Signaling, and Radiation to study the role interferon and pattern recognition receptor signaling transduction pathways play in modulating the immune system’s ability to recognize and...

Gynecologic Cancers
Immunotherapy

Immunotherapy for Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma

As reported in the Journal of Clinical Oncology by Naumann et al, the phase I/II CheckMate 358 trial found that nivolumab showed activity in a cohort of patients with recurrent or metastatic cervical, vaginal, or vulvar squamous cell carcinoma.   Study Details A total of 24 patients were enrolled...

lymphoma
immunotherapy

Michael J. LaRiviere, MD, on Non-Hodgkin Lymphoma: Induction Radiation Before CAR T-Cell Therapy for Resistant Disease

Michael J. LaRiviere, MD, of the University of Pennsylvania, discusses the safety and efficacy of an alternate radiation-based approach to using cytotoxic chemotherapy alone in preparation for CAR T-cell treatment (Abstract 135).

lung cancer
immunotherapy

Andreas Rimner, MD, on the PACIFIC Trial: Durvalumab for Stage III NSCLC

Andreas Rimner, MD, of Memorial Sloan Kettering Cancer Center, discusses study findings showing that, for patients with stage III non–small cell lung cancer, durvalumab reduced the rate of and time to disease progression vs placebo and also reduced the number of new distant lesions (Abstract LBA6).

Lung Cancer
Immunotherapy

Expert Point of View: Alex A. Adjei, MD, PhD

Alex A. Adjei, MD, PhD, of Mayo Clinic, Rochester, Minnesota, who was not involved in KEYNOTE-189 or KEYNOTE-021, provided some perspective on the exploratory analyses of tumor mutational burden from these and other studies. “Four studies at this meeting presented data on tumor mutational burden...

Genomics/Genetics
Immunotherapy

POLE/POLD1 Mutations Across Cancer Types and Association With Immune Checkpoint Inhibitor Therapy Outcomes

In a research letter published in JAMA Oncology, Wang et al identified the frequency of mutations in DNA polymerase epsilon (POLE) and delta 1 (POLD1) genes across cancer types and found that these mutations were associated with better survival outcomes among patients receiving immune checkpoint...

Lung Cancer
Immunotherapy

ASTRO 2019: Patterns of Disease Progression in Patients With Unresectable Stage III NSCLC: Analysis of the PACIFIC Trial

Andreas Rimner, MD, of Memorial Sloan Kettering Cancer Center, presented an update of the landmark PACIFIC trial at the 61st Annual Meeting of the American Society for Radiation Oncology (ASTRO) (Abstract LBA-6). In earlier reports from the randomized phase III trial, Antonia et al had evaluated...

Gynecologic Cancers
Immunotherapy

FDA Grants Approval to Lenvatinib/Pembrolizumab in Advanced Endometrial Cancer, Announces Project Orbis

The U.S. Food and Drug Administration (FDA) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the...

Gynecologic Cancers
Immunotherapy

Bevacizumab/Niraparib vs Niraparib Alone for Platinum-Sensitive Recurrent Ovarian Cancer

In the phase II NSGO-AVANOVA2/ENGOT-ov24 trial reported in The Lancet Oncology, Mansoor Raza Mirza, MD, and colleagues found that the combination of bevacizumab plus niraparib prolonged progression-free survival vs niraparib alone in women with platinum-sensitive recurrent ovarian cancer. Study...

Lung Cancer
Immunotherapy

ASTRO 2019: SBRT After Disease Progression on Immunotherapy Increases PFS in Patients With Metastatic NSCLC

Non–small cell lung cancer (NSCLC) accounts for the vast majority of all lung cancers—between 80% and 85% of those diagnosed in the United States—and is among the most deadly cancers for both men and women, exceeding the mortality rate of colon, breast, and pancreatic cancers combined. The results...

Lung Cancer
Immunotherapy

WCLC 2019: KEYNOTE-024 Survival Update Shows Benefit With Pembrolizumab vs Chemotherapy in Advanced NSCLC

First-line pembrolizumab monotherapy provides durable long-term overall survival benefit compared to chemotherapy in patients with advanced non–small cell lung cancer (NSCLC), according to data from the KEYNOTE-024 trial presented by Martin Reck, MD, PhD, at the International Association for the...

Solid Tumors
Immunotherapy

Liquid Biopsy to Determine Patient Response to Immune Checkpoint Blockade

Although studies have demonstrated that microsatellite instability (MSI) and high tumor mutational burden (TMB) are promising pan-tumor biomarkers for identifying patients for treatment with immune checkpoint blockade, obtaining tissue from unresectable or metastatic solid tumors for genetic...

Lung Cancer
Immunotherapy

WCLC 2019: Final Overall Survival Results of IMpower131 Trial in Advanced Squamous NSCLC

Patients with stage IV squamous non–small cell lung cancer (NSCLC) with high programmed cell death ligand 1 (PD-L1) expression treated with atezolizumab and chemotherapy experienced longer overall survival rates than those treated with chemotherapy alone. The data from the IMpower131 trial were...

Solid Tumors
Immunotherapy

Pamiparib Plus Tislelizumab in Advanced Solid Tumors

In an Australian phase Ia/b trial reported in The Lancet Oncology, Friedlander et al found evidence of activity of the combination of the poly (ADP-ribose) polymerase inhibitor pamiparib and the programmed cell death protein 1 inhibitor tislelizumab in patients with previously treated advanced...

Breast Cancer
Immunotherapy

T-DM1 Plus Neratinib in Metastatic HER2-Positive Breast Cancer

In the phase Ib NSABP Foundation Trial FB-10 reported in the Journal of Clinical Oncology, Jame Abraham, MD, and colleagues found evidence of activity of the combination of ado-trastuzumab emtansine (T-DM1) plus neratinib in metastatic HER2-positive breast cancer and identified the dose of the...

Lung Cancer
Immunotherapy

WCLC 2019: CASPIAN Trial Finds Addition of Durvalumab to Chemotherapy Improves Overall Survival in Patients With Extensive-Stage SCLC

The addition of durvalumab to chemotherapy improved overall survival in patients with extensive-stage small cell lung cancer (SCLC), according to research presented at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC) (Abstract PL02.11)....

Lung Cancer
Immunotherapy

WCLC 2019: Pooled Analysis of CheckMate 017 and 057: 5-Year Outcomes With Nivolumab vs Docetaxel in Previously Treated NSCLC

Pooled data on two clinical trials demonstrated patients with previously treated non–small cell lung cancer (NSCLC) treated with nivolumab had a greater than fivefold increase in 5-year overall survival rate compared to treatment with the chemotherapy docetaxel. Scott Gettinger, MD, of Yale...

Immunotherapy
Gastroesophageal Cancer

Pembrolizumab in Advanced Esophageal Squamous Cell Cancer With PD-L1 Expression of CPS ≥ 10

On July 30, 2019, pembrolizumab was approved for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed cell death ligand 1 (PD-L1; Combined Positive Score [CPS] ≥ 10), as determined by a U.S. Food and Drug...

Head and Neck Cancer
Immunotherapy

Pembrolizumab in First-Line Treatment of Head/Neck Squamous Cell Carcinoma

On June 10, 2019, pembrolizumab was approved for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma.1,2 Pembrolizumab was approved for use in combination with platinum and fluorouracil (5-FU) for all patients and as a single agent...

Immunotherapy
Multiple Myeloma

Daratumumab-Based Therapy for Patients With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplantation

On June 27, 2019, daratumumab was approved for use in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase...

Lung Cancer
Immunotherapy

WCLC 2019: First-Line Nivolumab/Ipilimumab in Special Populations With NSCLC

First-line therapy consisting of nivolumab plus ipilimumab showed a consistent safety profile in special populations with advanced non–small cell lung cancer (NSCLC), according to research presented by Fabrice Barlesi, MD, PhD, of Aix-Marseille University, Assistance Publique Hôpitaux de Marseille...

Lung Cancer
Immunotherapy

WCLC 2019: Two Studies Show Tumor Mutational Burden Not Associated With Pembrolizumab Efficacy in NSCLC

At the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC), two presentations showed that tumor mutational burden is not associated with the efficacy of pembrolizumab in combination with chemotherapy in patients with non–small cell lung cancer...

Gynecologic Cancers
Immunotherapy

Avelumab for Mismatch Repair–Deficient and Mismatch Repair–Proficient Endometrial Cancer

In a phase II trial reported in the Journal of Clinical Oncology, Panagiotis A. Konstantinopoulos, MD, PhD, and colleagues found evidence of promising activity of the programmed cell death ligand 1 (PD-L1) inhibitor avelumab in mismatch repair–deficient (MMRD) recurrent or persistent endometrial...

Lung Cancer
Immunotherapy

Does the Addition of Bevacizumab to Erlotinib in Advanced EGFR-Mutant NSCLC Improve PFS?

In a phase II trial reported in JAMA Oncology, Thomas E. Stinchcombe, MD, and colleagues found that the addition of bevacizumab to erlotinib did not significantly improve progression-free survival (PFS) in patients with advanced EGFR-mutant non–small cell lung cancer (NSCLC). Study Details The...

Kidney Cancer
Immunotherapy

Individualized Axitinib Regimens After Immunotherapy for Advanced Renal Cell Carcinoma

In a phase II study reported in The Lancet Oncology, Ornstein et al found that individualized axitinib regimens showed activity in patients with locally recurrent or metastatic renal cell carcinoma who had previously received immune checkpoint inhibitor therapy, although the progression-free...

Immunotherapy

Key Predictors of Response Rates to PD-1/PD-L1 Inhibitor Therapy Across Cancer Types

In a study reported in JAMA Oncology, Lee and Ruppin found that CD8-positive T-cell abundance, tumor mutational burden, and high PD1 gene expression were the strongest predictors of response to anti–programmed cell death protein 1/programmed cell death ligand 1 (PD-1/PD-L1) treatment across cancer...

Kidney Cancer
Immunotherapy

Extended Follow-up of CheckMate 214: Nivolumab/Ipilimumab vs Sunitinib as First-Line Treatment for Advanced RCC

As reported in The Lancet Oncology by Robert J. Motzer, MD, and colleagues, extended follow-up of the phase III CheckMate 214 trial has shown a maintained survival benefit for first-line nivolumab/ipilimumab vs sunitinib in patients with previously untreated intermediate- or poor-risk advanced...

Immunotherapy
Skin Cancer

Phase Ib Trial of Toripalimab/Axitinib in Asian Patients With Advanced Mucosal Melanoma

In a Chinese phase Ib study reported in the Journal of Clinical Oncology, Sheng et al reported activity with the combination of the anti–programmed cell death protein 1 (PD-1) agent toripalimab plus axitinib in patients with metastatic mucosal melanoma. As stated by the investigators, whereas...

Kidney Cancer
Prostate Cancer
Immunotherapy

Novel Treatments Under Study in Renal Cell Carcinoma and Prostate Cancer

There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...

Kidney Cancer
Prostate Cancer
Immunotherapy

Novel Treatments Under Study in Renal Cell Carcinoma and Prostate Cancer

There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...

Health-Care Policy
Immunotherapy

CMS Finalizes Decision to Cover CAR T-Cell Therapy for Medicare Beneficiaries

ON AUGUST 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy among recipients of Medicare benefits. FDA-approved CAR T-cell therapies are approved to treat patients ...

Lung Cancer
Immunotherapy

Optimal First-Line Therapy for Stage IV Non–Small Cell Lung Cancer: Immunotherapy Alone or With Chemotherapy?

Recent studies in non–small cell lung cancer (NSCLC) have shown benefit for combining checkpoint inhibitors with chemotherapy. Should combinations, therefore, be the first choice for treating patients with newly diagnosed stage IV disease? Two lung cancer experts debated this point at the 2019...

Immunotherapy

What Causes Liver Injury During Treatment With Pembrolizumab

Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a game changer...

Immunotherapy
Skin Cancer
Kidney Cancer
Lung Cancer

Long-Term Follow-up of Patients With Melanoma, Kidney Cancer, and Lung Cancer Receiving Nivolumab

As reported by Suzanne L. Topalian, MD, and colleagues in JAMA Oncology, long-term follow up of patients from a phase I expansion cohort study indicated 5-year overall survival rates of 34.2%, 27.7%, and 15.6% among patients who received nivolumab monotherapy for advanced melanoma, renal cell...

Immunotherapy
Skin Cancer

5-Year Follow-Up of KEYNOTE-006 Trial of Immunotherapy Regimens in Advanced Melanoma

In a post hoc 5-year follow-up of the KEYNOTE-006 trial reported in The Lancet Oncology, Caroline Robert, MD, PhD, and colleagues found that pembrolizumab maintained overall and progression-free survival benefits over ipilimumab in patients with advanced melanoma. In the primary analysis from the...

Immunotherapy

What Causes Liver Injury During Treatment With Pembrolizumab

Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a game changer...

lymphoma
immunotherapy

Nivolumab/Brentuximab Vedotin in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma

As reported in the Journal of Clinical Oncology by Zinzani et al, findings in a phase II expansion cohort of the CheckMate 436 study indicated high levels of activity with the combination of nivolumab and brentuximab vedotin in relapsed or refractory primary mediastinal large B-cell lymphoma. As...

solid tumors
immunotherapy

T-Cell Receptor Gene Therapy in HPV-Associated Epithelial Cancers

In a first-in-human phase I/II study reported in the Journal of Clinical Oncology, Doran et al found that autologous genetically engineered T cells expressing a T-cell receptor directed against the human papillomavirus (HPV)16 E6 oncoprotein were capable of inducing tumor regression in metastatic,...

lung cancer
immunotherapy

Pooled Analysis of 4-Year Survival With Nivolumab Therapy in Patients With Previously Treated Advanced NSCLC

In an analysis reported in The Lancet Oncology, Antonia et al identified long-term survival rates with nivolumab therapy in patients with previously treated advanced non–small cell lung cancer (NSCLC). The pooled analysis included data from the CheckMate 017, 057, 063, and 003 trials, each...

immunotherapy

Immune-Related Adverse Events Requiring Hospitalization in Patients Receiving Immune Checkpoint Inhibitors

In a single-center analysis reported in the Journal of Oncology Practice, Balaji et al found that immune-related adverse events associated with immune checkpoint inhibitor treatment often require hospitalization and multidisciplinary management. The study involved data from patients who had...

Immunotherapy
Symptom Management

Anti–PD-1/PD-L1 Rechallenge After Immune-Related Adverse Events

In a study reported in JAMA Oncology, Olivier Lambotte, MD, PhD, found that rechallenge with an immune checkpoint inhibitor after occurrence of immune-related adverse events was associated with occurrence of an immune-related adverse event in approximately half of patients, with no increase in...

Skin Cancer
Immunotherapy

Addition of IDO1 Inhibitor to Immunotherapy in Melanoma

As reported in The Lancet Oncology by Georgina V. Long, PhD, and colleagues, the phase III ECHO-301/KEYNOTE-252 trial showed no improvement in progression-free or overall survival with the addition of the IDO1 inhibitor epacadostat to pembrolizumab in unresectable stage III or stage IV melanoma....

Immunotherapy
Skin Cancer

Pembrolizumab for Advanced Merkel Cell Carcinoma

Late in 2018, pembrolizumab was granted accelerated approval in the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma.1,2 Supporting Efficacy Data Approval was based on Cancer Immunotherapy Trials Network protocol 9 (CITN-09), also known...

health-care policy
immunotherapy

CMS Finalizes Decision to Cover CAR T-Cell Therapy for Medicare Beneficiaries

On August 7, the Centers for Medicare & Medicaid Services (CMS) finalized the decision to cover U.S. Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy among recipients of Medicare benefits. FDA-approved CAR T-cell therapies are approved to...

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