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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...

breast cancer

Expert Point of View: Steven J. Isakoff, MD, PhD

Steven J. Isakoff, MD, PhD, a medical oncologist at Massachusetts General Hospital, Boston, commented on the results of the DESTINY-Breast01 trial. “These data are extraordinarily encouraging, suggesting we will have another new option for patients with metastatic HER2-positive breast cancer. The...

breast cancer

Novel Antibody-Drug Conjugate Shows Efficacy in Women With Pretreated, Metastatic HER2-Positive Breast Cancer

The novel antibody-drug conjugate [fam-] trastuzu­mab deruxtecan (T-DXd) achieved high response rates and durable responses in heavily pretreated patients with HER2-positive metastatic breast cancer, according to results of the phase II DESTINY-Breast 01 trial presented at the 2019 San Antonio...

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 ...

breast cancer

FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Patients With Unresectable or Metastatic HER2-Positive Breast Cancer

On December 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti–HER2-based regimens in the metastatic setting....

leukemia

Selected Abstracts From the 2019 ASH Annual Meeting & Exposition

To complement The ASCO Post’s comprehensive coverage of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic regimens for acute myeloid leukemia (AML). For full details of these...

lung cancer

Long-Term Data on Brigatinib in First-Line Setting of ALK-Positive Non–Small Cell Lung Cancer

Updated data from the phase III ALTA-1L trial were presented by D. Ross Camidge, MD, PhD, of the University of Colorado Cancer Center, Aurora, during the Presidential Session at the European Society for Medical Oncology (ESMO) Asia Congress 2019 in Singapore.1 The trial evaluated brigatinib vs...

hematologic malignancies
symptom management

Improved Prevention of Graft-vs-Host Disease Reported With Posttransplant Cyclophosphamide

Following allogeneic hematopoietic stem cell transplantation, cyclophosphamide significantly reduced grades II to IV acute and chronic extensive graft-vs-host disease compared with conventional immunosuppression, investigators reported during the Plenary Session at the 2019 American Society of...

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
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...

bladder cancer

FDA Approves Enfortumab Vedotin-ejfv for Previously Treated Advanced Urothelial Cancer

On December 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev) for adult patients with locally advanced or metastatic urothelial cancer who have previously received neoadjuvant or adjuvant treatment with a programmed cell death protein 1 ...

breast cancer

Veliparib/Chemotherapy Combination Active in HER2-Negative BRCA-Positive Advanced Breast Cancer

The addition of the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib to carboplatin/paclitaxel chemotherapy significantly improved progression-free survival in patients with advanced HER2-negative breast cancer and germline BRCA mutation compared with placebo plus chemotherapy, according to...

prostate cancer

FDA Approves Enzalutamide for Patients With Metastatic Castration-Sensitive Prostate Cancer

On December 16, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi) for patients with metastatic castration-sensitive prostate cancer. The FDA previously approved enzalutamide for patients with castration-resistant prostate cancer. ARCHES Trial Efficacy was investigated in...

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...

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...

breast cancer

SABCS 2019: 6-Year Analysis of the Addition of Pertuzumab to Trastuzumab Plus Chemotherapy as Adjuvant Therapy

Data from the 6-year analysis of the APHINITY trial showed that adding pertuzumab to the previous standard treatment of trastuzumab plus chemotherapy after surgery continued to reduce the risk of recurrence and death in patients with HER2-positive early breast cancer, according to findings...

breast cancer

SABCS 2019: 10-Year Follow-up of Adjuvant Accelerated Partial-Breast Irradiation vs Adjuvant Whole-Breast Irradiation

A 10-year follow-up study of patients with breast cancer who had been treated with accelerated partial-breast irradiation (APBI) after surgery showed that their rates of disease recurrence were similar to those of patients who had received whole-breast irradiation (WBI), according to data presented ...

breast cancer

SABCS 2019: Ribociclib/Letrozole vs Multiagent Chemotherapy in Patients With High-Risk Luminal B Breast Cancer

A phase II study by Gavilá et al evaluating the efficacy of the combination of the CDK4/6 inhibitor ribociclib and the aromatase inhibitor letrozole in combination as a neoadjuvant treatment in patients with high-risk luminal B breast cancer has found that the therapy produced response rates...

breast cancer

SABCS 2019: Postoperative S-1 Plus Endocrine Therapy for HR-Positive, HER2-Negative Breast Cancer

The postoperative combination of S-1, an oral fluoropyrimidine-based drug, with endocrine therapy improved invasive disease–free survival and 5-year invasive disease–free survival estimates in patients with hormone receptor (HR)-positive, HER2-negative breast cancer, according to results from the...

breast cancer

SABCS 2019: Adding Tucatinib to Capecitabine/Trastuzumab Improved Survival for Patients With Advanced HER2-Positive Breast Cancer

The addition of tucatinib to capecitabine and trastuzumab significantly improved progression-free survival and overall survival in patients with advanced HER2-positive breast cancer, with or without brain metastasis. These findings—from the HER2CLIMB study—were presented by Murthy et al at the 2019 ...

leukemia

ASH 2019: Oral Azacitidine Improves Survival in Older Patients With AML in First Remission

Treatment with an investigational oral form of azacitidine, CC-486, improved overall survival in older patients with newly diagnosed acute myeloid leukemia (AML) who were in remission following standard induction chemotherapy with or without consolidation therapy, according to a phase III study...

hematologic malignancies

Pretreatment Vitamin D Deficiency in Patients Receiving First-Line Treatment for Hodgkin Lymphoma

In a study reported in the Journal of Clinical Oncology, Sven Borchmann, MD, of the German Hodgkin Study Group, University Hospital of Cologne, and colleagues found that pretreatment vitamin D deficiency was associated with significantly poorer progression-free and overall survival in patients...

lung cancer

FDA Approves PD-L1 Inhibitor Plus Chemotherapy for First-Line Treatment of Metastatic Nonsquamous Non–Small Cell Lung Cancer

On December 4, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with chemotherapy (nab-paclitaxel and carboplatin) for the first-line treatment of adults with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic...

solid tumors

The Light at the End of the Tunnel in Urothelial Cancer Is Not a Train: Enfortumab Vedotin and Other Developments

There is an urgent need to develop new drugs for the treatment of urothelial cancer. Chemotherapy was the only approved treatment in advanced disease for 40 years, which was associated with response rates of between 30% and 50% in the front-line setting.1-3 However, durable remissions were...

gynecologic cancers

Niraparib for Homologous Recombination Deficiency–Positive Advanced Ovarian Cancer

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 October 23, 2019, the poly (ADP-ribose) polymerase...

lung cancer

Erlotinib Plus Ramucirumab: Ready for Prime Time?

The treatment of epidermal growth factor receptor (EGFR)-positive lung cancer changed dramatically after the results of the FLAURA trial showed improved progression-free survival with the third-generation EGFR tyrosine kinase inhibitor osimertinib as first-line therapy compared with...

hepatobiliary cancer

ClarIDHy and FIGHT-202 Trials Show Positive Results in the Treatment of Patients With Biliary Tract Cancer

Two studies reported at the European Society for Medical Oncology (ESMO) Congress 2019—ClarIDHy and FIGHT-202—demonstrated clinical benefits with novel molecularly targeted agents in the treatment of advanced cholangiocarcinoma. Currently, first-line treatment for locally advanced or metastatic...

Expert Point of View: Joshua Richter, MD

Joshua Richter, MD, Assistant Professor of Medicine, Hematology, and Medical Oncology at the Tisch Cancer Institute at Mount Sinai in New York, offered his thoughts on the CANDOR study, noting that the findings point to “a new and exciting treatment regimen for our patients with relapsed and...

multiple myeloma

Addition of Daratumumab Increases Benefit of Carfilzomib/Dexamethasone in Multiple Myeloma

In patients with relapsed or refractory multiple myeloma, the addition of daratumumab to carfilzomib plus dexamethasone improved multiple outcomes, compared with carfilzomib/dexamethasone alone, in the international phase III CANDOR trial.1 “Overall, carfilzomib/dexamethasone/daratumumab was...

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...

breast cancer

‘Unexpected’ Survival Benefit With Trilaciclib Plus Chemotherapy in Triple-Negative Breast Cancer

An unanticipated result of a randomized phase II study was the improvement in overall survival achieved with the investigational CDK4/6 inhibitor trilaciclib in women with metastatic triple-negative breast cancer. The drug was not being evaluated for its anticancer effects, but rather as a means of ...

lung cancer
immunotherapy

FDA Approves Atezolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC

On December 4, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with chemotherapy (nab-paclitaxel and carboplatin) for the first-line treatment of adults with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor...

prostate cancer

Biomarker-Driven Treatment Selection for Prostate and Other Genitourinary Cancers

As the Nobel Laureate Bob Dylan wrote, “The times they are a-changin’.” Heather Cheng, MD, PhD, Associate Professor, University of Washington, Associate Member, Fred Hutchinson Cancer Research Center, and Director, Seattle Cancer Care Alliance, Prostate Cancer Genetics Clinic, quoted this line in...

breast cancer

Emerging Alternatives in the Third-Line Setting for Metastatic HER2-Positive Breast Cancer

In the post-trastuzumab era, a number of U.S. Food and Drug Administration (FDA)-approved targeted agents for metastatic HER2-positive breast cancer are available, but there is no preferred option for third-line treatment and beyond. At the 2019 Chemotherapy Foundation Symposium, Shanu Modi, MD,...

skin cancer
immunotherapy

Updated Data From Clinical Trials on Nivolumab/Ipilimumab in Advanced Melanoma

More than one out of two patients with metastatic melanoma treated with the combination of nivolumab plus ipilimu-mab is still alive after 5 years, according to the longest follow-up of patients receiving this combination. In two additional studies, the immunotherapy duet also proved to be active...

lung cancer

Long-Term Survival With PD-1/PD-L1 Inhibitors in NSCLC

Although many commentaries on studies featured in The ASCO Post call for scrutiny of the fine points, this is not the case for the recent report by Antonia et al in The Lancet Oncology (reviewed in the current issue of The ASCO Post).1 This article serves as a well-deserved victory lap for the...

lung cancer

Final Overall Survival Results of IMpower131 Trial in Advanced Squamous NSCLC

In patients with stage IV squamous non–small cell lung cancer (NSCLC), those 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. For those participants without...

neuroendocrine tumors
lung cancer

Novel Therapies for Small Cell Lung Cancer and Neuroendocrine Tumors

Here is a glimpse at updated clinical trial data on newer therapies under study for the small cell lung cancer (SCLC) and advanced extrapancreatic neuroendocrine tumors. IMpower133 and ALTER: Novel Therapies for SCLC The treatment of small cell lung cancer has seen little progress in recent years,...

head and neck cancer

Nivolumab vs Chemotherapy in Advanced Esophageal Cancer

Nivolumab improved overall survival compared with chemotherapy in previously treated patients with esophageal squamous cell carcinoma in the final analysis of the phase III ATTRACTION-3 study. The data were presented at the European Society for Medical Oncology (ESMO) Congress 2019 Presidential...

Expert Point of View: Arndt Vogel, MD and Angela Lamarca, MD, PhD

Arndt Vogel, MD, of Hannover Medical School in Germany, who served as discussant of the two studies of immunotherapy in hepatocellular carcinoma, said the findings point to a promising future in the treatment of this malignancy. He commented that the responses observed with nivolumab in CheckMate...

immunotherapy
hepatobiliary cancer

‘Clinically Meaningful’ Outcomes Seen in Two Studies of First-Line Immunotherapy for Hepatocellular Carcinoma

In the first-line treatment of advanced hepatocellular carcinoma, checkpoint inhibitors led to favorable outcomes in studies reported at the European Society for Medical Oncology (ESMO) Congress 2019—though one study was technically negative. The current first-line standard of care for unresectable ...

gastrointestinal cancer

Pivotal Study Reports Positive Findings in Fourth-Line Setting for Advanced GIST

In a late-breaking, oral presentation at the European Society for Medical Oncology (ESMO) 2019 Congress, Margaret von Mehren, MD, presented results from INVICTUS, a pivotal phase III clinical study of ripretinib in patients with advanced gastrointestinal stromal tumor (GIST).1 Ripretinib is an...

breast cancer

ASCO Updates Breast Cancer Risk Reduction Guideline to Include Anastrozole

ASCO has updated a guideline on pharmacologic interventions for breast cancer risk reduction in postmenopausal women at increased risk of developing breast cancer.1 The original clinical practice recommendations for breast cancer risk reduction were published in 1999 and updated in 2002, 2009, and...

lung cancer
immunotherapy

Nivolumab/Ipilimumab: Another First-Line Option for Advanced NSCLC

The combination of nivolumab and ipilimumab improved overall survival compared with chemotherapy as first-line therapy for patients with advanced non–small cell lung cancer (NSCLC) and programmed cell death ligand 1 (PD-L1) expression of at least 1%, according to the results of CheckMate 227....

integrative oncology

Boswellia

The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, focus on the herbal extract...

colorectal cancer

Targeted Triplet Therapy Improved Overall Survival in BRAF-Mutated Colorectal Cancer

For patients with metastatic colorectal cancer harboring BRAF V600E mutations, three drugs seem to be better than two, the most recent analysis of the phase III BEACON CRC study has shown.1 The results, presented at the 2019 European Society for Medical Oncology (ESMO) Congress, were concurrently...

lymphoma

FDA Grants Accelerated Approval to Zanubrutinib for Pretreated Mantle Cell Lymphoma

On November 14, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa) for adult patients with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or ...

lymphoma
immunotherapy

Polatuzumab Vedotin Plus Bendamustine/Rituximab for Transplantation-Ineligible Relapsed or Refractory DLBCL

In a phase Ib/II trial reported in the Journal of Clinical Oncology, Laurie H. Sehn, MD, MPH, and colleagues found that the addition of polatuzumab vedotin to bendamustine/rituximab improved response rate and progression-free and overall survival among transplantation-ineligible patients with...

prostate cancer
breast cancer
bladder cancer
pancreatic cancer
kidney cancer
thyroid cancer
gynecologic cancers
immunotherapy

ESMO Congress 2019: Quick Takes From Key Clinical Trials

The ESMO Congress continues to grow as a pivotal platform for research in clinical oncology. At the ESMO Congress 2019, important findings were showcased in more than 2,200 studies, including 93 late-breaking abstracts. The ASCO Post summarized much of that news in separate articles over several...

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