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FDA Awards Six Grants to Fund New Clinical Trials of Medical Products for Treatment of Rare Diseases

The U.S. Food and Drug Administration (FDA) announced it has awarded six new clinical trial research grants to principal investigators from academia and industry, totaling more than $16 million over the next 4 years. These grants, awarded through the Congressionally funded Orphan Products Grants...

covid-19

FDA Approves Remdesivir for Patients With COVID-19 Requiring Hospitalization

On October 22, the U.S. Food and Drug Administration (FDA) approved the antiviral drug remdesivir (Veklury) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization. Remdesivir should only be administered...

breast cancer

Final Efficacy Results From the ExteNET Trial: Neratinib in Pretreated Patients With HR-Positive, HER2-Positive Early Breast Cancer

In an analysis from the phase III ExteNET trial reported in Clinical Breast Cancer, Arlene Chan, MD, and colleagues found significant improvements in efficacy outcomes with the administration of neratinib vs placebo starting at 1 year or sooner after neoadjuvant/adjuvant trastuzumab-based therapy...

multiple myeloma

Ixazomib Maintenance in Newly Diagnosed Patients With Multiple Myeloma Not Undergoing Stem Cell Transplant: TOURMALINE-MM4 Trial

As reported in the Journal of Clinical Oncology by Meletios A. Dimopoulos, MD, and colleagues, the phase III TOURMALINE-MM4 trial has shown that postinduction maintenance with ixazomib prolonged progression-free survival vs placebo in patients with newly diagnosed multiple myeloma not undergoing...

gastroesophageal cancer
immunotherapy

KEYNOTE-181 Trial: Second-Line Pembrolizumab vs Chemotherapy in Advanced Esophageal Cancer

As reported in the Journal of Clinical Oncology by Takashi Kojima, MD, and colleagues, the phase III KEYNOTE-181 trial has shown that second-line pembrolizumab improved overall survival vs investigator’s choice of chemotherapy in patients with advanced or metastatic esophageal cancer with a PD-L1...

pancreatic cancer

Making Strides in the Management of Pancreatic Cancer

The Special Conference on Pancreatic Cancer, sponsored by the American Association for Cancer Research (AACR) and held virtually this year, showcased cutting-edge discoveries and promising advances in the understanding and treatment of pancreatic cancer, reported by some of the world’s foremost...

Conquer Cancer Announces 2020 Quality Care Symposium Merit Awards

Conquer Cancer, the ASCO Foundation® is pleased to announce the recipients of its 2020 Quality Care Symposium Merit Awards.  These distinguished awards recognize oncology fellows and trainees who are first authors on top-ranking abstracts selected for presentation at the virtual ASCO Quality Care...

covid-19

Impact of Cytotoxic Chemotherapy Within 5 Weeks of COVID-19 Diagnosis in Patients With Cancer

In a single-institution study reported in the Journal of Clinical Oncology, Justin Jee, MD, PhD, of the Department of Medicine, Memorial Sloan Kettering Cancer Center (MSK), New York, and colleagues found that receipt of cytotoxic chemotherapy within 35 days of COVID-19 diagnosis in patients with...

breast cancer

Novel Indications and New Drugs for the Treatment of Patients With Breast Cancer

Over the past year (December 2019–September 2020), the U.S. Food and Drug Administration (FDA) granted approval to several novel drugs and new indications for therapeutic agents used in breast cancer. Pertuzumab/Trastuzumab/Hyaluronidase-zzxf On June 29, 2020, the FDA approved a new fixed-dose...

lymphoma

Good Outcomes With PET-Directed Therapy for Limited-Stage Diffuse Large B-Cell Lymphoma

As reported in the Journal of Clinical Oncology by Daniel O. Persky, MD, of the University of Arizona Cancer Center, Tucson, and colleagues, the phase II Intergroup National Clinical Trials Network Study S1001 has shown good outcomes with positron-emission tomography (PET)-directed therapy in...

global cancer care

Cancer on the Global Stage: Incidence and Cancer-Related Mortality in Botswana

The ASCO Post is pleased to continue this occasional special focus on the worldwide cancer burden. In this issue, we feature a close look at the cancer incidence and mortality rates in Botswana. The aim of this special feature is to highlight the global cancer burden for various countries of the...

solid tumors
immunotherapy

Association of Tumor Mutational Burden With Response to Pembrolizumab in Previously Treated Patients With Advanced Solid Tumors

A prospective biomarker analysis of the multicohort phase II KEYNOTE-158 trial reported by Marabelle et al in The Lancet Oncology found that patients with previously treated advanced solid tumors were more likely to respond to pembrolizumab monotherapy if they had high tissue tumor mutational...

gynecologic cancers
immunotherapy

Lenvatinib/Pembrolizumab in Previously Treated Patients With Advanced Endometrial Cancer

As reported in the Journal of Clinical Oncology by Vicky Makker, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues, findings from a phase Ib/II trial indicate that the combination of lenvatinib and pembrolizumab is active in patients with previously treated advanced...

gynecologic cancers

SGO 2020: Updated Analysis of VELIA Trial Shows Antitumor Activity in Ovarian Cancer, but Is It Enough?

An updated analysis of the phase III VELIA/GOG-3005 trial, presented during the 2020 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer Webinar Series,1 suggested synergy between the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib and platinum chemotherapy in the...

gynecologic cancers
immunotherapy

KEYNOTE-100: In Women With Advanced Ovarian Cancer, Pembrolizumab Yields Modest Antitumor Efficacy

the final results of the phase II KEYNOTE-100 study of pembrolizumab in women with advanced and recurrent ovarian cancer showed that pembrolizumab monotherapy produced modest clinical activity. Ursula Matulonis, MD, of Dana-Farber Cancer Institute, Harvard Medical School, reported the data at the...

gynecologic cancers

ESMO 2019: Veliparib Plus First-Line Chemotherapy and as Maintenance Therapy in High-Grade Ovarian Cancer

In the phase III VELIA/GOG-3005 trial—reported at the European Society for Medical Oncology (ESMO) Congress 20191 and simultaneously published in The New England Journal of Medicine2—Robert L. Coleman, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues found that the ...

global cancer care

Cancer on the Global Stage: Incidence and Cancer-Related Mortality in Cambodia

The ASCO Post is pleased to continue this occasional special focus on the worldwide cancer burden. In this issue, we feature a close look at the cancer incidence and mortality rates in Cambodia. The aim of this special feature is to highlight the global cancer burden for various countries of the...

lymphoma
immunotherapy

Tafasitamab-cxix in the Treatment of Diffuse Large B-Cell 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. On July 31, 2020, tafasitamab-cxix, a CD19-directed...

gastrointestinal cancer

Third- or Later-Line Treatment With Infigratinib in Patients With Cholangiocarcinoma and FGFR2 Fusions

At the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2020 Virtual, Milind Javle, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues reported that third- and later-line treatment with the selective fibroblast growth factor...

lymphoma

Selinexor in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

On June 22, 2020, the oral nuclear export inhibitor selinexor was granted accelerated approval for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic...

breast cancer

Fixed-Dose Subcutaneous Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf in HER2-Positive Breast Cancer

On June 29, 2020, a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) for subcutaneous injection was approved for the following indications1,2: Use in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced,...

lymphoma

Tazemetostat for Adults With Relapsed or Refractory Follicular Lymphoma

On June 18, 2020, the EZH2 inhibitor tazemetostat was granted accelerated approval for the treatment of adults with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test, and who have...

National Comprehensive Cancer Network Celebrates Its 25th Year

It was February 1996, and the first annual meeting of the National Comprehensive Cancer Network® (NCCN®) was drawing to a close, when Chief Executive Officer (CEO) Bruce R. Ross, MD, invited comments from the floor. An oncologist who had attended at the urging of a friend—somewhat reluctantly—stood ...

genomics/genetics

Higher Prevalence of Germline Mutations Identified in Young Adults With Cancer

A new study has found that a higher-than-expected proportion of young adults with cancer harbor genetic germline mutations that have implications for treatment, surveillance, and other family members who may be at risk. Patients with “early-onset cancers”—cancers that typically do not occur in...

pancreatic cancer

Addition of Pegvorhyaluronidase Alfa to Nab-paclitaxel and Gemcitabine in Hyaluronan-High Metastatic Pancreatic Cancer

In the phase III HALO 109-301 trial reported in the Journal of Clinical Oncology, Eric Van Cutsem, MD, PhD, and colleagues found that the addition of pegvorhyaluronidase alfa (PEGPH20) to nab-paclitaxel plus gemcitabine (AG) did not improve overall survival or progression-free survival in patients...

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...

lymphoma

Outcomes With PET-Directed Therapy for Limited-Stage DLBCL

As reported in the Journal of Clinical Oncology by Daniel O. Persky, MD, and colleagues, the phase II Intergroup National Clinical Trials Network Study S1001 has shown good outcomes with positron-emission tomography (PET)-directed therapy in patients with limited-stage diffuse large B-cell lymphoma ...

ASCO’s CancerLinQ Launches the SmartLinQ™ QOPI® Certification Pathway, an Automated Solution for Quality Reporting for QOPI-Certified Practices

ASCO’s CancerLinQ® has launched the SmartLinQ™ QOPI® Certification Pathway, an application that empowers oncology practices to automate quality measure tracking and reporting for participation in ASCO’s Quality Oncology Practice Initiative (QOPI) Certification Program, a 3-year certification...

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...

covid-19

Experimental COVID-19 Vaccine Generates Immune Response, Deemed Safe in Phase I Trial

According to a press release from the National Institutes of Health, an investigational vaccine designed to protect against SARS-CoV-2, the virus that causes COVID-19—mRNA-1273—was generally well tolerated and prompted neutralizing antibody activity in healthy adults. These interim results were...

hepatobiliary cancer

ESMO World GI: Third- or Later-Line Treatment With Infigratinib in Patients With Cholangiocarcinoma and FGFR2 Fusions

At the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2020 Virtual, Javle et al reported that third- and later-line treatment with the selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor infigratinib resulted in a progression-free survival and...

lymphoma

Selinexor for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

In the phase IIb SADAL trial reported in The Lancet Haematology, Kalakonda et al found that the oral nuclear export inhibitor selinexor produced durable responses in patients with relapsed or refractory diffuse large B-cell lymphoma. Findings in the trial supported the recent accelerated U.S. Food...

lymphoma

Selinexor for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

In the phase IIb SADAL trial reported in The Lancet Haematology, Kalakonda et al found that the oral nuclear export inhibitor selinexor produced durable responses in patients with relapsed or refractory diffuse large B-cell lymphoma. Findings in the trial supported the recent accelerated U.S. Food...

hepatobiliary cancer

Third- or Later-Line Treatment With Infigratinib in Patients With Cholangiocarcinoma and FGR2 Fusions

At the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2020 Virtual, Javle et al reported that third- and later-line treatment with the selective fibroblast growth factor receptor (FGFR) 1–3 inhibitor infigratinib resulted in a progression-free survival and...

gynecologic cancers

Veliparib Plus Chemotherapy Shows Antitumor Activity in Front-Line Treatment of Ovarian Cancer, but Is It Enough?

An updated analysis of the phase III VELIA/GOG-3005 trial, presented during the 2020 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer Webinar Series,1 suggested synergy between the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib and platinum chemotherapy in the...

solid tumors

Study Shows Blood Test Can Identify Multiple Cancers in Asymptomatic Women

A large, “first-of-its-kind” trial showed that a blood test could identify cancers in women with no history of cancer and who were asymptomatic. Of about 10,000 women enrolled in the study, 134 had positive results on blood screening; 26 of these women were found to have cancers. Conventional...

From Ecuador to Nashville to Dallas: An Early Path to a Career in Medicine for Carlos L. Arteaga, MD

Carlos L. Arteaga, MD, is Director of the Harold C. Simmons Cancer Center and Associate Dean for Oncology Programs, UT Southwestern Medical Center (UTSW), Dallas. He is an expert in breast cancer who has authored more than 350 publications in the areas of oncogenes in breast tumors, targeted...

Conquer Cancer Names 2020 Women Who Conquer Cancer Mentorship Award Recipients

Conquer Cancer, the ASCO Foundation®, has named Dawn L. Hershman, MD, MS, FASCO, as the 2020 Hologic, Inc Endowed Women Who Conquer Cancer Mentorship Award recipient, and Lillian L. Siu, MD, FRCPC, FASCO, as the International Women Who Conquer Cancer Mentorship Award recipient. The 2020 Women Who ...

Spotlight on Women Who Conquer Cancer

Women Who Conquer Cancer (WWCC) is a groundbreaking program that is committed to supporting early-career women researchers by funding research grants through Conquer Cancer, the ASCO Foundation®. Since its inception 7 years ago, the program has raised nearly $5 million, funded 27 Young Investigator ...

kidney cancer

HIF2A Inhibitor for von Hippel-Lindau Disease–Associated Renal Cell Carcinoma

In an international trial, treatment with MK-6482, a small-molecule inhibitor of hypoxia-inducible factor (HIF)-2a, was well tolerated and resulted in clinical responses for patients with von Hippel-Lindau disease–associated renal cell carcinoma (RCC). The results of the phase II trial were shared ...

pancreatic cancer
prostate cancer

Data From TAPUR Study Cohorts on Olaparib for BRCA-Mutated Advanced Prostate and Pancreatic Cancers

Positive results from two cohorts of the Targeted Agent and Profiling Utilization Registry (TAPUR) study provide real-world evidence to support recent clinical trial data that demonstrate a role for olaparib in the treatment of advanced prostate and pancreatic cancers with BRCA1/2-inactivating...

breast cancer

Tucatinib in Previously Treated HER2-Positive Metastatic Breast Cancer

On April 17, 2020, tucatinib was approved for use in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer. These patients included those with brain metastases and those who have received one or more prior...

skin cancer
immunotherapy

Combining Pembrolizumab With IL-12 Electroporation May Improve Clinical Response in Patients With Immunologically 'Cold' Melanoma

Patients with non–immune-infiltrated “cold” tumors have low frequencies of intratumoral tumor-reactive, checkpoint-positive cytotoxic lymphocytes, making them less responsive to checkpoint blockage than patients with immune-infiltrated “hot” tumors. A phase II study by Alain P. Algazi, MD, and...

lung cancer
immunotherapy

Addition of Pembrolizumab to Docetaxel for Previously Treated Immunotherapy-Naive Patients With Advanced Lung Cancer

In the single-institution phase II PROLUNG trial reported in JAMA Oncology, Oscar Arrieta, MD, and Christian Rolfo, MD, PhD, and colleagues found that the addition of pembrolizumab to docetaxel improved objective response rates and progression-free survival in immunotherapy-naive patients with...

colorectal cancer
gastrointestinal cancer
immunotherapy

Regorafenib Plus Nivolumab in Advanced Gastric and Colorectal Cancers

In a Japanese phase Ib/dose-expansion trial reported in the Journal of Clinical Oncology, Fukuoka et al found that the combination of regorafenib and nivolumab showed activity in patients with previously treated gastric cancer and colorectal cancer with microsatellite stable/mismatch...

ASCO, Conquer Cancer Honor Leaders in Cancer Care With 2020 Special Awards

ASCO and Conquer Cancer, the ASCO Foundation®, are proud to recognize the winners of ASCO’s 2020 Special Awards and Conquer Cancer’s Women Who Conquer Cancer Mentorship Awards. The recipients of these awards have worked to transform cancer care around the world. David A. Karnofsky Memorial Award...

Robert L. Coleman, MD, Named Chief Scientific Officer for the US Oncology Network

On March 31, 2020, the US Oncology Network (The Network) named cancer researcher Robert L. Coleman, MD, FACOG, FACS, as its new Chief Scientific Officer. In this role, Dr. Coleman will be the senior-most clinician scientist on The US Oncology Network leadership. Dr. Coleman, who most recently...

breast cancer

21-Gene Assay Recurrence Score and Risk of Locoregional Recurrence in Hormone Receptor–Positive, Node-Positive Breast Cancer

A retrospective analysis from the Southwest Oncology Group S8814 trial, reported by Wendy A. Woodward, MD, PhD, of the Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, and colleagues in JAMA Oncology,1 showed that a low 21-gene assay recurrence score was...

immunotherapy
breast cancer
skin cancer
lung cancer

What’s the Current Status of Neoadjuvant Immunotherapy?

For several tumor types, can the successes achieved with immunotherapy in the metastatic and adjuvant settings be replicated in the neoadjuvant setting? An explosion in clinical trials—with more than 300 listed on ClinicalTrials.gov—point to “yes.” “The neoadjuvant use of immunotherapy is of great ...

prostate cancer

Upfront Apalutamide Delays Time to Second Progression in Metastatic Castration-Sensitive Prostate Cancer

The addition of apalutamide to androgen-deprivation therapy (ADT) reduced the risk of second disease progression or death (PFS2) by 34% vs ADT alone in patients with metastatic castration-sensitive prostate cancer, in a post hoc analysis of the phase III TITAN trial presented at the 2020...

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