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breast cancer
immunotherapy

KEYNOTE-522: A Biomarker Resource for PD-1 Inhibition in Early Triple-Negative Breast Cancer

In the phase III KEYNOTE-522 trial reported in The New England Journal of Medicine and reviewed in this issue of The ASCO Post, Schmid et al1 found that the addition of pembrolizumab to neoadjuvant chemotherapy in stage II or III triple-negative breast cancer significantly improved the pathologic...

leukemia
pancreatic cancer
neuroendocrine tumors
lung cancer
gynecologic cancers
lymphoma

FDA Pipeline: Priority Review in AML, Fast Track Designations for Pancreatic Cancer and Neuroendocrine Tumors

Over the past 2 weeks, the U.S. Food and Drug Administration (FDA) granted Priority Review to a treatment for acute myeloid leukemia (AML); Fast Track designations for agents in pancreatic cancer and pancreatic/nonpancreatic neuroendocrine tumors; approvals for companion diagnostic tests;...

breast cancer
immunotherapy

Immunotherapy ‘Comes of Age’ in Breast Cancer

Immunotherapeutics in breast cancer will likely not be limited to late-stage triple-negative breast cancer. Earlier lines, combination regimens, and expansion into different disease subtypes should become part of this emerging landscape, according to Hope S. Rugo, MD, FASCO, Professor of Medicine...

Susan Band Horwitz, PhD, Named Recipient of 2020 Szent-Györgyi Prize

The National Foundation for Cancer Research (NFCR) recently announced that Susan Band Horwitz, PhD, has been selected to receive the 2020 Szent-Györgyi Prize for Progress in Cancer Research. Dr. Horwitz is being recognized for pioneering the understanding, at the molecular level, of the mechanisms...

breast cancer

Brief Highlights From the 2019 San Antonio Breast Cancer Symposium

In addition to our regular coverage of the 2019 San Antonio Breast Cancer Symposium, the following reports from the meeting include studies you may have missed. We hope you find them of interest. Ribociclib/Letrozole as Neoadjuvant Therapy As neoadjuvant therapy in women with high-risk hormone...

breast cancer
immunotherapy

Expert Point of View: Kevin Kalinsky, MD, MS

Commenting on SAFIR02-IMMUNO for The ASCO Post, Kevin Kalinsky, MD, MS, Associate Professor of Medicine at ­NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, said the findings of the analysis were in accordance with other studies in metastatic breast cancer, but they came...

breast cancer
immunotherapy

No Improved Pathologic Complete Response With Atezolizumab in Early Triple-Negative Breast Cancer

The addition of the checkpoint inhibitor atezolizumab to chemotherapy with carboplatin and nab-paclitaxel failed to significantly improve pathologic complete response rates compared with chemotherapy alone in patients with early high-risk, locally advanced triple-negative breast cancer. According...

lung cancer
immunotherapy

ASCO/CCO Update Guideline for Selecting Systemic Treatment in Stage IV NSCLC Without Driver Mutations

ASCO and Cancer Care Ontario (CCO) have published an update to a joint guideline on systemic therapy for stage IV non–small cell lung cancer (NSCLC) without driver mutations.1 “The treatment of stage IV NSCLC has become increasingly more complicated, and, with the advent of immunotherapy and the...

pancreatic cancer

Two Novel Pegylated Agents Fail in Metastatic Pancreatic Cancer

Two novel treatments once thought to hold promise in the treatment of metastatic pancreatic cancer have not proved to be effective in phase III trials, investigators reported at the 2020 Gastrointestinal Cancers Symposium. When combined with standard chemotherapy, a pegylated form of human...

pancreatic cancer
cost of care

2020 GI Cancers Symposium: Cost of Pancreatic Cancer Care Over Time

In a study presented by Picozzi et al at the 2020 Gastrointestinal Cancers Symposium, researchers found that even as drug costs increased over the past decade, total inflation-adjusted pancreatic cancer care expenses declined, as did costs related to quality of life (Abstract 773). Health...

breast cancer

First-Line Atezolizumab Plus Nab-paclitaxel in Advanced Triple-Negative Breast Cancer: Second Overall Survival Interim Analysis

As reported in The Lancet Oncology by Peter Schmid, MD, and colleagues, the prespecified second interim analysis of overall survival in the phase III IMpassion130 trial has shown no overall survival benefit with the addition of atezolizumab to nab-paclitaxel as first-line treatment of...

lung cancer
immunotherapy

Atezolizumab With Chemotherapy for Metastatic Nonsquamous NSCLC Without EGFR/ALK Aberrations

On December 3, 2019, atezolizumab in combination with nab-paclitaxel and carboplatin was approved for first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumore aberrations.1,2 The approval was based on findings in the open-label phase III...

breast cancer

Mixed Results With Weekly Nab-paclitaxel, Denosumab in Primary Breast Cancer

A weekly schedule of nab-paclitaxel as part of neoadjuvant chemotherapy significantly improved pathologic complete response compared with nab-paclitaxel given 2 weeks out of every 3 weeks (2/3) in patients with primary breast cancer, with a greater magnitude of benefit in patients with...

lung cancer
immunotherapy

Maintenance Bevacizumab With or Without Pemetrexed in Advanced Nonsquamous NSCLC

In a Japanese phase III trial reported in the Journal of Clinical Oncology, Seto et al found that the addition of maintenance pemetrexed to bevacizumab did not significantly improve overall survival in patients with previously untreated, advanced nonsquamous non–small cell lung cancer (NSCLC)...

breast cancer

Hope S. Rugo, MD, on Metastatic Triple-Negative Breast Cancer: Retrospective Analysis of PD-L1 Immunohistochemistry Assays

Hope S. Rugo, MD, of the University of California San Francisco Comprehensive Cancer Center, discusses a retrospective analysis on the effectiveness of the VENTANA PD-L1 SP142 assay, the Dako 22C3 assay, and the VENTANA SP263 assay as predictors of response to atezolizumab plus nab-paclitaxel in...

breast cancer
immunotherapy

First-Line Atezolizumab Plus Nab-paclitaxel in Advanced Triple-Negative Breast Cancer: Second Overall Survival Interim Analysis

As reported in The Lancet Oncology by Peter Schmid, MD, and colleagues, the prespecified second interim analysis of overall survival in the phase III IMpassion130 trial has shown no overall survival benefit with the addition of atezolizumab to nab-paclitaxel as first-line treatment of unresectable, ...

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...

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...

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...

lung cancer
immunotherapy

Does Adding Pembrolizumab or Placebo to Chemotherapy for Patients With Metastatic Squamous NSCLC Improve Quality of Life?

In a health-related quality of life analysis from the phase III KEYNOTE-407 trial reported in the Journal of Clinical Oncology, Mazières et al found that the patients with metastatic squamous non–small cell lung cancer (NSCLC) who received pembrolizumab in addition to chemotherapy had better...

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...

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...

Gastrointestinal Cancer Research From ESMO 2019

This week, we discuss two studies in gastrointestinal cancers presented at this year’s European Society for Medical Oncology Congress. First up, the NEOLAP trial assessed induction chemotherapy with nab-paclitaxel plus gemcitabine or sequential FOLFIRINOX followed by surgical exploration in...

pancreatic cancer

Nab-paclitaxel/Gemcitabine/Cisplatin for Previously Untreated, Advanced Pancreatic Cancer

In a phase Ib/II pilot study reported in JAMA Oncology, Jameson et al found that treatment with nab-paclitaxel, gemcitabine, and cisplatin was active in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. Study Details In the study, 25 patients were enrolled between...

tecentriq
abraxane

Atezolizumab for PD-L1–Positive Locally Advanced or Metastatic Triple-Negative Breast Cancer

EARLIER THIS YEAR, atezolizumab was granted accelerated approval in combination with nab-paclitaxel in the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express programmed cell death ligand 1 (PD-L1–stained tumor-infiltrating...

pancreatic cancer

ESMO 2019: High Conversion Rate With Certain Induction Chemotherapy Regimens Is Associated With Improved Overall Survival in Locally Advanced Pancreatic Cancer

Induction chemotherapy with nab-paclitaxel plus gemcitabine or sequential FOLFIRINOX (fluorouracil, leucovorin, oxaliplatin, and irinotecan) followed by surgical exploration induced high conversion rates in patients with locally advanced pancreatic cancer, and conversion was associated with...

pancreatic cancer

Volker Kunzmann, MD, on Advanced Pancreatic Cancer: Findings on nab-Paclitaxel/Gemcitabine and FOLFIRINOX

Volker Kunzmann, MD, of the University of Würzburg/Comprehensive Cancer Center Mainfranken, discusses the final results of a phase II multicenter trial on the conversion rate in locally advanced pancreatic cancer after nab-paclitaxel/gemcitabine- or FOLFIRINOX-based induction chemotherapy (Abstract ...

breast cancer
global cancer care

Canadian Cancer Organizations Team Up to Focus on New Approach to Metastatic Breast Cancer

At a press conference at McGill University, Stand Up To Cancer Canada (SU2C Canada), the Canadian Cancer Society (CCS), and the Canadian Institutes of Health Research (CIHR) announced the launch of the SU2C Canada Metastatic Breast Cancer Dream Team to pursue the development of a new drug...

onivyde
lynparza

Targeting an Important Tumor Vulnerability With Maintenance Olaparib in Germline BRCA-Mutated Pancreatic Cancer

In the POLO trial, which is discussed in this issue of The ASCO Post, Golan and colleagues evaluated the potential benefit of maintenance olaparib after disease stability or response to a minimum of 4 months of platinum-based chemotherapy in patients with metastatic pancreatic cancer and a...

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...

pancreatic cancer

Surgical Resection Among Patients Receiving Primary Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Cancer

In an Italian prospective cohort study reported in JAMA Surgery, Maggino et al found that among patients receiving primary chemotherapy for newly diagnosed pancreatic ductal adenocarcinoma, conversion to surgical resection was achieved in 24% of those with borderline resectable disease and 9% of...

breast cancer
immunotherapy

Two Pivotal Studies in Breast Cancer Report Further Analyses

At the 2019 ASCO Annual Meeting, two pivotal breast cancer trials reported final or additional analyses: one confirmed the negative results seen in earlier reports,1 and the other supported a new survival benchmark.2 KRISTINE: Neoadjuvant T-DM1/Pertuzumab Sara A. Hurvitz, MD, of the David Geffen...

Expert Point of View: Jiping Wang, MD, PhD

“The jury is still out,” said APACT’s invited discussant, Jiping Wang, MD, PhD, a biostatistician and hepatobiliary pancreas surgical oncologist at Dana-Farber Cancer Institute and Brigham and Women’s Hospital, Boston. “The final overall survival analysis is needed to know the real benefit from...

pancreatic cancer

APACT Trial: Nab-paclitaxel/Gemcitabine vs Gemcitabine Alone in Adjuvant Treatment of Pancreatic Cancer

The largest adjuvant trial in pancreatic adenocarcinoma, the global phase III APACT trial, evaluated the combination of adjuvant nab-paclitaxel/gemcitabine vs gemcitabine monotherapy in patients with resected pancreatic cancer. Results of the study were reported by Margaret A. Tempero, MD, of the...

breast cancer
immunotherapy

Peter Schmid, MD, PhD, and Hope S. Rugo, MD, on Metastatic Triple-Negative Breast Cancer: Atezolizumab Plus Nab-paclitaxel

Hope S. Rugo, MD, of the University of California, San Francisco, and Peter Schmid, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, discuss an update of the IMpassion130 interim overall survival analysis of atezolizumab plus nab-paclitaxel in previously untreated locally...

hepatobiliary cancer

Actively Recruiting Clinical Trials Focused on Novel Drug Combinations for Gallbladder and Biliary Tract Cancers

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies that are focused on novel drug regimens in gallbladder and biliary tract cancers. These trials are attempting to determine the best dosages, side-effect profiles, and effectiveness of new...

lung cancer
immunotherapy

IMpower130: Addition of First-Line Atezolizumab to Chemotherapy in Metastatic Nonsquamous NSCLC

As reported in The Lancet Oncology by West et al, the phase III IMpower130 trial found that the addition of atezolizumab to carboplatin plus nab-paclitaxel significantly improved overall and progression-free survival in first-line treatment of stage IV nonsquamous non–small cell lung cancer...

pancreatic cancer

Margaret A. Tempero, MD, on Pancreatic Cancer: Adjuvant Nab-paclitaxel and Gemcitabine

Margaret A. Tempero, MD, discusses phase III results from the multicenter APACT trial, which showed that adjuvant nab-paclitaxel plus gemcitabine may be an option for patients who are ineligible for treatment with FOLFIRINOX (Abstract 4000).

breast cancer

GeparSepto: Long-Term Clinical Outcomes With Neoadjuvant Nab-paclitaxel vs Solvent-Based Paclitaxel in Early Breast Cancer

As reported in the Journal of Clinical Oncology by Untch et al, long-term follow-up in the GeparSepto trial showed that patients with early breast cancer receiving neoadjuvant nab-paclitaxel vs solvent-based paclitaxel followed by epirubicin/cyclophosphamide had better invasive disease–free...

AACR Announces Three Distinguished Public Service Award Recipients

The American Association for Cancer Research (AACR) presented the Distinguished Public Service Award to three individuals for their work in preventing and curing all cancers through research, education, communication, collaboration, science policy and advocacy, and funding for cancer research at ...

FDA Oncology Drug Approvals Granted Between May 21, 2018 and May 14, 2019

Over the past year (May 2018–May 2019), the U.S. Food and Drug Administration (FDA) granted approval and accelerated approval to a number of new oncology drugs and biosimilars. Here we list the new FDA-approved labels and indications. AVELUMAB (BAVENCIO) and AXITINIB (INLYTA) has been approved as a ...

hepatobiliary cancer

Triplet Chemotherapy in Unresectable Locally Advanced or Metastatic Biliary Tract Cancers

In a phase II trial reported in JAMA Oncology, Rachna T. Shroff, MD, and colleagues found that the addition of nab-paclitaxel to standard gemcitabine and cisplatin resulted in promising outcomes in patients with unresectable locally advanced or metastatic biliary tract cancers. The study included...

pancreatic cancer

Lifestyle Modifications and Screening of Patients at High Risk Can Reduce Deaths From Pancreatic Cancer

After disclosing that he had been diagnosed with stage IV pancreatic cancer, Alex Trebek, longtime host of the popular television game show Jeopardy!, vowed that he would beat the disease despite the low associated survival rate. His statement has brought pancreatic cancer back into the public...

immunotherapy
breast cancer
lung cancer
prostate cancer
kidney cancer
bladder cancer
colorectal cancer
pancreatic cancer
sarcoma
leukemia
skin cancer
head and neck cancer

NCCN Clinical Practice Guidelines in Oncology: 2019 Updates

In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®), covering eight tumor types. NCCN Guidelines are now published for more than 70 tumor types and topics. Some of the key updates for 2019 were presented...

hepatobiliary cancer

Addition of Nab-paclitaxel to Gemcitabine and Cisplatin in Advanced Biliary Tract Cancers

In a phase II trial reported in JAMA Oncology, Shroff and colleagues found that the addition of nab-paclitaxel to standard gemcitabine and cisplatin resulted in promising outcomes in patients with unresectable locally advanced or metastatic biliary tract cancers. The study included 60 patients...

pancreatic cancer

Trends in Neoadjuvant Therapy for Resectable Pancreatic Cancer

SEVERAL STUDIES at the 2019 Gastrointestinal Cancers Symposium evaluated the benefits of neoadjuvant treatment in patients with pancreatic cancer—and in patients deemed fully resectable, not just “borderline” resectable.1-3 Although the standard of care for resectable pancreatic ductal...

kidney cancer
bladder cancer
prostate cancer
hepatobiliary cancer

Conference Highlights From the 2019 Gastrointestinal and Genitourinary Cancers Symposiums

THIS YEAR saw a huge turnout and a large number of scientific abstracts presented at both the 2019 Gastrointestinal (GI) Cancers Symposium, held on January 17–19, and the 2019 Genitourinary (GU) Cancers Symposium, held on February 14–16, both in San Francisco. The GU Cancers Symposium attracted...

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...

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...

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