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Immunotherapy

Subcutaneous Daratumumab Improves Outcomes for Patients With Light-Chain Amyloidosis, Study Finds

Patients with light-chain amyloidosis may soon have a new standard of care, according to data presented during the 25th European Hematology Association (EHA25) Virtual Annual Congress.1 Results of the phase III ANDROMEDA study have shown that adding subcutaneous daratumumab to the triplet...

Bladder Cancer
Immunotherapy

First-Line Atezolizumab Plus Platinum-Based Chemotherapy vs Chemotherapy Alone in Advanced Urothelial Cancer

As reported in The Lancet by Matthew D. Galsky, MD, of Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, and colleagues, the phase III IMvigor130 trial has shown prolonged progression-free survival with first-line atezolizumab plus platinum-based chemotherapy vs...

Bladder Cancer
Immunotherapy

Long-Term Outcomes With Pembrolizumab for Cisplatin-Ineligible Advanced Urothelial Cancer

As reported in the Journal of Clinical Oncology by Jacqueline Vuky, MD, of Oregon Health & Science University, Portland, and colleagues, long-term follow-up in the phase II KEYNOTE-052 study has shown durable responses with first-line pembrolizumab in cisplatin-ineligible locally advanced or...

Bladder Cancer
Immunotherapy

‘Switch Maintenance’ Pembrolizumab for Metastatic Urothelial Cancer

In a phase II study reported in the Journal of Clinical Oncology,1 Matthew D. Galsky, MD, of The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, and colleagues found that maintenance pembrolizumab produced additional responses and improved progression-free survival vs...

Bladder Cancer
Immunotherapy

Novel Indications and New Drugs for the Treatment of Bladder Cancer

Pembrolizumab: On January 8, 2020, pembrolizumab (Keytruda) was approved by the U.S. Food and Drug Administration (FDA) for 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...

Bladder Cancer
Immunotherapy

Early Data Show Activity for Enfortumab Vedotin Plus Pembrolizumab in Advanced Bladder Cancer

It may be possible to use a platinum-free combination as first-line treatment for advanced or metastatic urothelial carcinoma in cisplatin-ineligible patients, if the results of the phase Ib/II EV-103 trial hold up. The combination of the newly approved antibody-drug conjugate (enfortumab vedotin)...

Bladder Cancer
Immunotherapy

Maintenance Avelumab Improves Survival in Advanced Bladder Cancer

Maintenance therapy with avelumab and best supportive care significantly prolonged overall survival vs best supportive care alone in patients with advanced urothelial carcinoma that did not progress on first-line platinum-based chemotherapy, according to an interim analysis of the phase III JAVELIN ...

Kidney Cancer
Immunotherapy

Salvage Nivolumab Plus Ipilimumab After Prior Immune Checkpoint Inhibitor Therapy in Patients With Metastatic Renal Cell Carcinoma

In a study reported in the Journal of Clinical Oncology,1 Anita Gul, MD, of the Cleveland Clinic Taussig Cancer Institute, and colleagues found that salvage therapy with nivolumab/ipilimumab was capable of producing a response after prior PD-1 pathway inhibitor therapy in some patients with...

Kidney Cancer
Immunotherapy

First-Line Combination Treatments Improve Outcomes vs Sunitinib in Advanced Renal Cell Carcinoma

Two recently reported phase III trials have shown the benefits of combination therapy vs sunitinib in the first-line treatment of advanced renal cell carcinoma. As reported in The New England Journal of Medicine by Brian I. Rini, MD, of Cleveland Clinic Taussig Cancer Institute, and colleagues, the ...

Kidney Cancer
Immunotherapy

Novel Indications and New Drugs for the Treament of Patients With Renal Cell Carcinoma

Pembrolizumab Plus Axitinib: On April 19, 2019, pembrolizumab (Keytruda) was approved for use in combination with the small-molecule tyrosine kinase inhibitor axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma. Approval was based on findings in the phase...

Kidney Cancer
Immunotherapy

Immune Checkpoint Inhibitor Rechallenge in Metastatic Renal Cell Carcinoma

In a study presented during the ASCO20 Virtual Scientific Program1 and published as a brief report in JAMA Oncology,2 Praful Ravi, MB, BChir, of the Dana-Farber Cancer Institute, Boston, and colleagues found that rechallenge with immune checkpoint inhibitor therapy was capable of producing...

Prostate Cancer
Kidney Cancer
Bladder Cancer
Immunotherapy

Genitourinary Oncology Highlights 2019–2020 Almanac

Over the past year, we have seen significant advances in the treatment of prostate, kidney, and urothelial cancers that will benefit patients now and in the future. We have learned about the final results of important clinical trials across multiple genitourinary cancers disease states leading to...

Skin Cancer
Immunotherapy

Pembrolizumab Monotherapy as First-Line Treatment for Patients With Unresectable Cutaneous Squamous Cell Carcinoma

In the French phase II CARSKIN trial reported in the Journal of Clinical Oncology, Maubec et al found that pembrolizumab monotherapy produced durable responses in the first-line treatment of unresectable cutaneous squamous cell carcinoma. Study Details In the multicenter trial, 39 patients (primary ...

Colorectal Cancer
Immunotherapy

Pembrolizumab for First-Line Treatment of Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer

On June 29, 2020, pembrolizumab was approved for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer.1 Supporting Efficacy Data Approval was based on findings in the randomized,...

Leukemia
Immunotherapy

Gemtuzumab Ozogamicin in Pediatric Patients With Newly Diagnosed CD33-Positive AML

On June 16, 2020, the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive acute myeloid leukemia (AML) was extended to include pediatric patients aged 1 month and older.1,2 Supporting Efficacy Data Approval was supported by findings from the phase III AAML0531 trial...

Lung Cancer
Immunotherapy

Neoadjuvant Atezolizumab Plus Chemotherapy Produces High Major and Complete Pathologic Response Rates in Resectable NSCLC

In a phase II study reported in The Lancet Oncology, Catherine A. Shu, MD, of Columbia University Irving Medical Center, and colleagues found that neoadjuvant treatment with atezolizumab plus nab-paclitaxel/carboplatin produced a major pathologic response in 57% of patients and pathologic complete...

Lymphoma
Immunotherapy

Highlights of Research in Lymphomas Presented During the EHA25 Virtual Congress

To complement The ASCO Post’s continued coverage of the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual), here are a few abstracts selected from the meeting proceedings focusing on clinical research in Hodgkin and marginal zone lymphomas. Omission of...

Lung Cancer
Immunotherapy

Incorporating Immunotherapy Into Treatment of Early-Stage NSCLC

There is a strong rationale for incorporating immunotherapy into the treatment of early-stage non–small cell lung cancer (NSCLC), given the breakthrough results with PD-1 checkpoint inhibitors as monotherapy, combined with immunotherapy, or combined with chemotherapy in advanced-stage NSCLC. As...

Gynecologic Cancers
Immunotherapy

Avelumab for Patients With Gestational Trophoblastic Tumors Resistant to Single-Agent Chemotherapy

In the French phase II TROPHIMMUN trial reported in the Journal of Clinical Oncology, Benoit You, MD, PhD, and colleagues found that avelumab normalized human chorionic gonadotropin (hCG) levels in approximately half of women with gestational trophoblastic tumors resistant to single-agent...

Hepatobiliary Cancer
Immunotherapy

First-Line Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma

In a phase Ib trial reported in the Journal of Clinical Oncology, Richard S. Finn, MD, and colleagues found that the combination of lenvatinib and pembrolizumab produced durable responses in patients with unresectable hepatocellular carcinoma who had received no prior systemic chemotherapy. As...

Kidney Cancer
Lung Cancer
Myelodysplastic Syndromes
Solid Tumors
Skin Cancer
Lymphoma
Pancreatic Cancer
Breast Cancer
Immunotherapy

FDA Pipeline: Designations in Kidney and Lung Cancers, Myelodysplastic Syndromes, and More

Over the past few weeks, the U.S. Food and Drug Administration (FDA) has issued designations and accepted applications for novel agents, as well as approved companion diagnostics. We summarize these regulatory movements below. Breakthrough Therapy Designation for MK-6482 in von Hippel-Lindau...

Hepatobiliary Cancer
Immunotherapy

Combination Immunotherapy in Advanced Biliary Tract Cancers

In a subgroup analysis of an Australian phase II trial reported in JAMA Oncology, Klein et al found that the combination of nivolumab and ipilimumab was active in patients with advanced biliary tract cancers. Study Details The phase II trial is enrolling patients with advanced rare cancers. The...

Lymphoma
Immunotherapy

Anti-CD30 CAR T-Cell Therapy for Patients With Relapsed or Refractory Hodgkin Lymphoma

In a pooled analysis of two parallel single-center phase I/II studies reported in the Journal of Clinical Oncology, Ramos et al found that anti-CD30 chimeric antigen receptor (CAR) T-cell therapy produced responses in a high proportion of patients with relapsed or refractory Hodgkin lymphoma. As...

Multiple Myeloma
Immunotherapy

FDA Grants Accelerated Approval to Belantamab Mafodotin-blmf for Pretreated Patients With Relapsed or Refractory Multiple Myeloma

On August 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to belantamab mafodotin-blmf (Blenrep), an anti-B-cell maturation antigen antibody-drug conjugate, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies,...

Supportive Care
Immunotherapy

ASCO Guideline Supports Continued Use of Dexamethasone for Patients Receiving Checkpoint Inhibitors and Emetogenic Chemotherapy

The ASCO guideline on the use of antiemetics has been updated to include new anticancer agents, antiemetics, and regimens.1 The guideline also addresses a growing concern among some oncologists that corticosteroids and their immunosuppressive abilities could potentially compromise the efficacy of...

immunotherapy

Ralph R. Weichselbaum, MD, on Radiotherapy and Immunotherapy in Oligometastatic Disease

Ralph R. Weichselbaum, MD, of the University of Chicago Cancer Research Center, explores the question of whether radiotherapy is the principal curative treatment with immunotherapy or activates immunotherapy. He also discussed how to improve the interaction of these treatments, perhaps with vaccination, transfer of genetically engineered T cells, or checkpoint inhibitors (Session ED37).

immunotherapy

Silvia Formenti, MD, on Testing Radiation and Immune Checkpoint Blockade in Different Tumor Settings

Silvia Formenti, MD, of Weill Cornell Medical College, discusses her continuing work, and the promising results emerging, in combining radiotherapy with immunotherapy to boost abscopal response rates. This combination therapy extends the use of radiotherapy to promote antitumor T-cell responses for both local and metastatic disease (Session ED37).

Skin Cancer
Immunotherapy

FDA Approves Atezolizumab Plus Cobimetinib/Vemurafenib for Advanced BRAF V600–Mutated Melanoma

On July 30, the U.S. Food and Drug Administration (FDA) approved the PD-L1 inhibitor atezolizumab (Tecentriq) plus the MEK inhibitor cobimetinib (Cotellic) and the selective BRAF kinase inhibitor vemurafenib (Zelboraf) for the treatment of patients with advanced BRAF V600 mutation–positive...

Skin Cancer
Immunotherapy

Pembrolizumab in Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma

As reported in the Journal of Clinical Oncology by Grob et al, the first interim analysis of the phase II KEYNOTE-629 trial has shown that treatment with pembrolizumab resulted in durable responses in patients with recurrent or metastatic cutaneous squamous cell carcinoma. The study supported the...

Lung Cancer
Immunotherapy

Anti-TIGIT Antibody Plus Atezolizumab Move Forward in Advanced NSCLC

Tiragolumab, an anti-TIGIT antibody, plus the PD-L1 inhibitor atezolizumab exhibited early clinical activity and was tolerated in patients with advanced solid tumors, including those with metastatic non–small cell lung cancer (NSCLC) that was PD-L1–positive and untreated with prior checkpoint...

Multiple Myeloma
Immunotherapy

CANDOR Trial: Carfilzomib, Dexamethasone, and Daratumumab vs Carfilzomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

As reported in The Lancet by Meletios Dimopoulos, MD, and colleagues, the phase III CANDOR trial has shown prolonged progression-free survival with carfilzomib, dexamethasone, and daratumumab (KdD) vs carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma....

lung cancer
immunotherapy

Combination Immunotherapy Approaches

In this video, Drs. Ramalingam, Brahmer, and Wakelee discuss the latest in emerging data on chemo/immunotherapy and immunotherapy-based combination approaches for the treatment of non–small cell lung cancer. They review recent data presented during the ASCO20 Virtual Scientific Program, including CheckMate 227 and CheckMate 9LA, as well as the associated clinical implications.

Lymphoma
Immunotherapy

FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma

On July 24, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel (Tecartus), a CD19-directed genetically modified autologous T-cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. “Tremendous...

Lymphoma
Immunotherapy

Role of Rituximab in the Treatment of Children and Adolescents With Mature B-Cell Non-Hodgkin Lymphoma

Minard-Colin et al recently reported for the European Intergroup for Childhood Non-Hodgkin Lymphoma/Children’s Oncology Group (EICNHL/COG) a significant improvement in event-free survival among children and adolescents (aged 6 months to 18 years) with high-risk mature B-cell non-Hodgkin lymphoma...

Lymphoma
Immunotherapy

Addition of Rituximab to Standard Chemotherapy Improves Event-Free and Overall Survival in Children With High-Risk, Mature B-Cell Non-Hodgkin Lymphoma

In a European Intergroup for Childhood Non-Hodgkin Lymphoma/Children’s Oncology Group phase III trial reported in The New England Journal of Medicine, Véronique Minard‑Colin, MD, PhD, of Gustave Roussy, Université Paris-Saclay, Villejuif, France, and colleagues found that the addition of rituximab...

Gastroesophageal Cancer
Immunotherapy

Nivolumab in Previously Treated Esophageal Squamous Cell Carcinoma

On June 10, 2020, nivolumab was approved for treatment of patients with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings from the open-label,...

Solid Tumors
Immunotherapy

Pembrolizumab for Adult and Pediatric Patients With Tumor Mutational Burden–High Solid Tumors

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 June 16, 2020, pembrolizumab was granted accelerated...

Skin Cancer
Immunotherapy

Small Study Evaluates Neoadjuvant vs Adjuvant Nivolumab Plus Ipilimumab in Stage III Melanoma

The neoadjuvant combination of nivolumab and ipilimumab yielded a continued benefit in relapse-free survival vs adjuvant use of the same combination therapy in 20 patients with stage III macroscopic melanoma. This finding is based on 3-year follow-up results of the phase Ib OpACIN trial, presented...

Lung Cancer
Immunotherapy

Can Radiomics Predict Survival in Patients With NSCLC Receiving Immunotherapy?

Immunotherapy with immune checkpoint inhibitors has made great strides in the treatment of many cancers, but only between 25% and 50% of patients respond with clinical benefit, and these agents come with adverse events and high price tags. Thus, preselection of patients who are likely to respond to ...

Breast Cancer
Immunotherapy

T-DM1 in Patients With HER2-Positive Breast Cancer and Brain Metastases: KAMILLA Trial

An exploratory subgroup analysis of the KAMILLA trial represents the largest reported cohort of patients with HER2-positive breast cancer and brain metastases treated with the anti-HER2 antibody-drug conjugate ado-trastuzumab emtansine, or T-DM1, in a prospective setting. Researchers observed...

Lymphoma
Immunotherapy

Outcomes With Axicabtagene Ciloleucel in the Nontrial Setting in Patients With B-Cell Non-Hodgkin Lymphoma

In a study reported in the Journal of Clinical Oncology, Caron A. Jacobson, MD, and colleagues found that commercial use of the chimeric antigen receptor T-cell therapy axicabtagene ciloleucel in patients with relapsed or refractory B-cell non-Hodgkin lymphoma was associated with an overall...

lung cancer
immunotherapy

Nasser K. Altorki, MD, on Lung Cancer: Radiotherapy and Immune Checkpoint Blockade in the Neoadjuvant Setting

Nasser K. Altorki, MD, of Weill Cornell Medical College, discusses study findings that suggest neoadjuvant low-dose focal stereotactic body radiation plus immune checkpoint blockade (ICB) is safe and causes no surgical delays in early-stage lung cancer, and that major pathologic response rates are likely to be comparable to those with chemotherapy/ICB combinations (Session ED37).

Gastroesophageal Cancer
Immunotherapy

Margetuximab/Pembrolizumab for Previously Treated Patients With HER2-Positive Advanced Gastroesophageal Adenocarcinoma

In a phase Ib/II trial reported in The Lancet Oncology, Daniel V.T. Catenacci, MD, and colleagues found that the combination of margetuximab and the anti–PD-1 therapy pembrolizumab showed evidence of activity in patients with previously treated HER2-positive gastroesophageal adenocarcinoma. As...

Lymphoma
Multiple Myeloma
Immunotherapy

FDA Pipeline: Novel Treatments for Hematologic Malignancies

Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to pembrolizumab for the second-line treatment of patients with relapsed or refractory Hodgkin lymphoma, and also accepted a supplemental new drug application for selinexor for pretreated patients with multiple myeloma....

Skin Cancer
Immunotherapy

Pembrolizumab for Advanced Melanoma: Impact of BRAF-Mutation Status and Prior Therapeutic Regimens

In a pooled analysis reported in JAMA Oncology, Igor Puzanov, MD, MSCI, and colleagues identified objective response rates and progression-free and overall survival rates with pembrolizumab treatment among patients with advanced melanoma according to BRAF V600E/K–mutation status and prior BRAF/MEK...

Hepatobiliary Cancer
Immunotherapy

Phase Ib Trial of Atezolizumab With or Without Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma

The combination of atezolizumab and bevacizumab was recently approved by the U.S. Food and Drug Administration for the treatment of unresectable or metastatic hepatocellular carcinoma on the basis of findings from the phase III IMbrave150 trial, which showed superior overall and progression-free...

Immunotherapy
Symptom Management

Study Identifies Factors That May Predict Toxicities in Patients Treated With CAR T-Cell Therapy

Chimeric antigen receptor (CAR) T-cell therapy has proved to be a valuable treatment option for patients with lymphoma in whom other therapies have failed. In clinical trials, the cellular immunotherapy was shown to provide durable remissions for nearly 40% of patients with large B-cell lymphoma....

Neuroendocrine Tumors
Immunotherapy

Two Studies Focus on Emerging Treatment Options for Patients With Neuroendocrine Tumors

Two new studies led by Renuka Iyer, MD, Section Chief for Gastrointestinal Oncology at Roswell Park Comprehensive Cancer Center, and published in Oncotarget and Cancer, respectively, highlight possible new treatment options for patients with neuroendocrine tumors. SurVaxM The first report,...

Skin Cancer
Immunotherapy

Potential Association of Impaired Spermatogenesis and Immune Checkpoint Inhibitor Therapy in Patients With Metastatic Melanoma

In a study reported as a research letter in JAMA Oncology, Scovell et al identified a potential association between the use of immune checkpoint inhibitors and impaired spermatogenesis using autopsy tissue findings in men with a history of metastatic melanoma. Study Details The study involved...

Hepatobiliary Cancer
Immunotherapy

Atezolizumab Plus Bevacizumab for Unresectable or Metastatic Hepatocellular Carcinoma

On May 29, 2020, atezolizumab in combination with bevacizumab was approved for treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.1-3 Supporting Efficacy Data Approval was based on findings in the international, open-label,...

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