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Showing 2201 - 2250FDA Approves Durvalumab as Part of a First-Line Combination Regimen for Extensive-Stage SCLC
On March 27, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (SCLC). CASPIAN Trial Efficacy of this combination in patients...
Selected ASH Abstracts on Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
To complement The ASCO Post’s continued 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 therapies for newly diagnosed chronic lymphocytic leukemia (CLL) and...
Phase II Trial Finds Neoadjuvant Immunotherapy Feasible in Oral Cavity Cancer
The results of a phase II study suggest that a short course of immunotherapy prior to surgery for oral cavity cancer may trigger tumor regression, possibly providing long-term benefits for patients. According to data presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium,1 a 3-week ...
Immune-Restorative Agent May Boost Immunotherapy Response in Advanced Head and Neck Cancer
Immune modulation with checkpoint inhibitors has shown beneficial effects in advanced head and neck squamous cell carcinoma, but responses have been limited to a small number of patients. According to data presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium, however, an...
Phase III JAVELIN Gastric 100 Trial Finds No Survival Benefit for Maintenance Avelumab
In the phase III JAVELIN Gastric 100 trial, a strategy called “switch maintenance” with the immune checkpoint inhibitor avelumab after 12 weeks of first-line induction chemotherapy did not statistically improve overall survival for treatment-naive patients with HER2-negative advanced gastric or...
Pembrolizumab in MSI-H and CPS ≥ 10 Advanced Gastric or Gastroesophageal Junction Cancer: Subanalysis of KEYNOTE-059, -061, and -062
The survival benefit of pembrolizumab in advanced gastric/gastroesophageal junction cancer with microsatellite instability–high (MSI-H) tumors or a combined positive score (CPS) ≥ 10 was established in post hoc subanalysis of three KEYNOTE trials. Findings were presented at the 2020...
Cisplatin/Gemcitabine Alone and With Veliparib in BRCA-Mutated Advanced Pancreatic Cancer
In patients with pancreatic ductal adenocarcinoma and a germline BRCA/PALB2 mutation, first-line therapy with cisplatin plus gemcitabine yielded high response rates and encouraging survival, according to Eileen M. O’Reilly, MD, of Memorial Sloan Kettering Cancer Center, who presented the findings...
Maintenance Olaparib in BRCA1/2-Positive Pancreatic Cancer Yields Improved Progression-Free Survival, Preserves Quality of Life
Health-related quality of life was preserved during maintenance olaparib in patients with BRCA 1/2-positive pancreatic cancer, as evidenced by a low symptom burden over time.1 POLO investigators reported their findings in posters presented at the 2020 Gastrointestinal Cancers Symposium. Other...
Mature Follow-up of BEACON CRC Study Reports Quality-of-Life Measures and Survival Outcomes
For patients with previously treated metastatic colorectal cancer harboring BRAF V600E mutations, the phase III BEACON CRC study showed the benefit for combining two or three targeted agents vs the standard of care.1 With further follow-up, the study has now also shown a benefit for the triplet and ...
Selected Abstracts on Novel Treatments in Colon, Hepatocellular, and Biliary Tract Cancers
The ASCO Post has reported on the pivotal trials presented at the 2020 Gastrointestinal Cancers Symposium in several issues. Featured here are the findings of several additional abstracts worthy of mention. Intermittent Oxaliplatin in Stage II or III Colon Cancer As adjuvant treatment for stage II...
Pembrolizumab Plus Radiotherapy Worthy of Further Study in Locally Advanced Squamous Cell Head and Neck Cancer
The combination of the checkpoint inhibitor pembrolizumab and definitive radiation therapy appears to be a safe and feasible option for patients with locally advanced head and neck cancer who are not eligible for cisplatin, according to data presented at the 2020 Multidisciplinary Head and Neck...
Survival Benefits Achieved With Pembrolizumab in MSI-H and CPS ≥ 10 Gastric/Gastroesophageal Junction Cancer
Post hoc subanalyses of three KEYNOTE trials established the survival benefit of pembrolizumab in advanced gastric/gastroesophageal junction cancer with microsatellite instability–high (MSI-H) tumors or a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥ 10 (ie, the number of...
Off-the-Shelf Dendritic Vaccine Shows Benefit in Kidney Cancer
Ilixadencel is a cell-based, allogeneic, off-the-shelf product aimed at priming the anticancer immune response when injected intratumorally. The phase II MERECA study evaluated this allogeneic dendritic cell product given with sunitinib in 88 patients with metastatic renal cell carcinoma. The study ...
Therapy Is Keeping My Metastatic Breast Cancer Manageable
Despite being vigilant about adhering to my annual schedule of screening mammography, in 2002, I was diagnosed with stage III triple-negative breast cancer. The diagnosis scared me, and I wondered if I was going to die. Determined to do what I could to survive the cancer, I underwent aggressive...
Tazemetostat for Advanced Epithelioid Sarcoma
On January 23, 2020, tazemetostat was granted accelerated approval for the treatment of adults and pediatric patients aged 16 and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.1,2 Supporting Efficacy Data Approval was based on the finding of...
Selected ASH Abstracts on Novel Treatments in Acute Lymphoblastic Leukemia
To complement The ASCO Post’s continued 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 therapies for newly diagnosed and relapsed or refractory acute...
Avapritinib for Gastrointestinal Stromal Tumor With PDGFRA Exon 18 Mutation
On January 9, 2020, avapritinib was approved for treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.1,2 It is the first therapy approved for...
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...
Treating Patients With Chronic Lymphocytic Leukemia in 2020
With the availability of a number of effective targeted agents for the treatment of chronic lymphocytic leukemia (CLL), the question arises whether chemotherapy still has a role in treating this malignancy. At the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition, CLL...
Acalabrutinib Plus Obinutuzumab Superior to Obinutuzumab Plus Chlorambucil as Front-Line Treatment of CLL
Ibrutinib was the first Bruton’s tyrosine kinase (BTK) inhibitor to dramatically transform the treatment of patients with chronic lymphocytic leukemia (CLL) and other hematologic malignancies. The second-generation BTK inhibitor acalabrutinib is a more selective BTK inhibitor designed to have an...
Expert Point of View: Richard L. Schilsky, MD, FACP, FSCT, FASCO
Richard L. Schilsky, MD, FACP, FSCT, FASCO, ASCO’s Chief Medical Officer and a gastrointestinal oncologist himself, was pleased to see the TAPUR study bearing fruit among patients with metastatic colorectal cancer. “Colorectal cancer is a very common disease, but we have not made much progress in...
FDA Pipeline: Priority Review in DLBCL, Fast Track Designations in T-Cell Lymphoma and Adenoid Cystic Carcinoma
Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to a combination therapy in diffuse large B-cell lymphoma (DLBCL); gave Fast Track designations for treatments in T-cell lymphoma and adenoid cystic carcinoma; granted Orphan Drug designation to an agent for the ...
NSABP B-42 Trial 10-Year Update: Impact of Extended Letrozole on Disease-Free Survival
“In the 10-year analysis of the NSABP B-42 trial, the effect of extended treatment with 5 years of letrozole on disease-free survival persisted and reached statistical significance. There was no significant improvement in overall survival with letrozole, but letrozole continued to provide a...
Small Study Explores Impact of Novel Regimen on Pembrolizumab for Triple-Negative Breast Cancer
In the phase II KEYNOTE-890 trial, patients with inoperable advanced triple-negative breast cancer who received one intratumoral tavokinogene telseplasmid injection followed by electroporation and pembrolizumab, several patients with skin or subcutaneous tumors saw metastatic lesions disappear,...
Phase III SOPHIA Trial Evaluates Margetuximab/Chemotherapy vs Trastuzumab/Chemotherapy for HER2-Positive Breast Cancer
The second interim analysis of the phase III SOPHIA trial demonstrated a significant though modest improvement in progression-free survival, response rate, and clinical benefit with the addition of margetuximab to chemotherapy vs trastuzumab plus chemotherapy in patients with HER2-positive...
Phase III KEYNOTE-522: Pembrolizumab Benefits Outcome in Neoadjuvant, Adjuvant Settings in Triple-Negative Breast Cancer
In patients with triple-negative breast cancer, the addition of pembrolizumab to neoadjuvant and adjuvant chemotherapy achieves higher rates of pathologic complete response compared with placebo, according to results of the phase III KEYNOTE-522 trial presented at the 2019 San Antonio Breast Cancer ...
Expert Point of View: A. Jo Chien, MD
A. Jo Chien, MD, Associate Professor at UCSF’s Helen Diller Comprehensive Cancer Center, San Francisco, was the formal discussant of this abstract. Dr. Chien said that a median follow-up of 3-years is relatively short for this trial, considering about 75% of patients had hormone receptor–positive...
Adjuvant Ado-Trastuzumab Emtansine vs Paclitaxel Plus Trastuzumab in Early HER2-Positive Breast Cancer
Results of the randomized, phase II ATEMPT trial showed that the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) failed to demonstrate improved safety when compared with paclitaxel plus trastuzumab as adjuvant therapy in patients with stage 1 HER2-positive breast cancer. These results of...
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...
Phase II DESTINY-Breast01: T-DXd Effective in Pretreated, Metastatic HER2-Positive Breast Cancer
In heavily pretreated patients with HER2-positive metastatic breast cancer [fam-]trastuzumab deruxtecan-nxki (T-DXd), a novel antibody-drug conjugate, achieved high response rates and durable responses, according to results of the phase II DESTINY-Breast01 trial presented at the 2019 San Antonio...
Chemotherapy, Trastuzumab, and Pertuzumab in Early HER2-Positive, Node-Positive Breast Cancer: Six-Year Follow-up of APHINITY Trial
Martine J. Piccart, MD, PhD, FASCO, reported that at 6-year follow-up of the APHINITY trial there was a modest, but not statistically significant, overall survival benefit for the addition of pertuzumab to chemotherapy plus trastuzumab vs chemotherapy/trastuzumab as adjuvant therapy in patients...
Phase III HER2CLIMB Trial Yields Positive Data in Patients With HER2-Positive Metastatic Breast Cancer and Brain Metastasis
The investigational oral agent tucatinib added to trastuzumab/capecitabine reduced the risk of death by one-third and reduced the risk of disease progression or death by one-half in patients with heavily pretreated metastatic HER2-positive breast cancer, including those with untreated or previously ...
Early FDG-PET Allows De-escalation of Chemotherapy in Metastatic Seminoma
In patients with metastatic seminoma, the early use of 18F-fluorodeoxyglucose (FDG)–positron-emission tomography (PET) to risk-stratify patients enabled the de-escalation of chemotherapy, avoiding treatment with bleomycin—one of the most toxic drugs used to treat this cancer—and excessive doses of...
Expert Point of View: Daniel V.T. Catenacci, MD
Daniel V.T. Catenacci, MD, Associate Professor of Medicine and Director of the Gastrointestinal Oncology Program at the University of Chicago, was the JAVELIN Gastric 100 study’s invited discussant. After offering an extensive background on the use of immunotherapy in gastric or gastroesophageal...
No Survival Benefit for Maintenance Avelumab in Advanced Gastric or Gastroesophageal Junction Cancer
In the phase III JAVELIN Gastric 100 trial, a strategy called “switch maintenance” with the immune checkpoint inhibitor avelumab after 12 weeks of first-line induction chemotherapy did not statistically improve overall survival for treatment-naive patients with HER2-negative advanced gastric or...
New POLO Data Further Support Maintenance Olaparib in BRCA1/2-Positive Pancreatic Cancer
In posters presented at the 2020 Gastrointestinal Cancers Symposium, POLO investigators reported that health-related quality of life was preserved during maintenance olaparib in patients with BRCA 1/2-positive pancreatic cancer, as evidenced by a low symptom burden over time.1 Other studies...
FDA Pipeline: Priority Review in Lung Cancer, Breakthrough Therapy Designation in Head and Neck Cancer, and More
This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to brigatinib for the treatment of ALK-positive lung cancer and Breakthrough Therapy designation to a potential first-in-class oral antagonist of inhibitors of apoptosis proteins for the treatment of head and neck...
2020 Head and Neck Cancers Symposium: Immune Restorative Agent May Boost Immunotherapy Response in Advanced Head and Neck Cancer
Immune modulation with checkpoint inhibitors has shown benefit in advanced head and neck squamous cell carcinoma, but responses have been limited to a small number of patients. According to data presented by Gregory T. Wolf, MD, FACS, Professor Emeritus in the Department of Otolaryngology-Head and...
Three vs Six Months of Adjuvant Chemotherapy for High-Risk Stage II Colorectal Cancer
As reported in JAMA Oncology by Petrelli et al, noninferiority in relapse-free survival for 3 vs 6 months of adjuvant chemotherapy was not established among patients with resected high-risk stage II colorectal cancer in the Italian phase III TOSCA trial. A potential regimen effect was observed,...
2020 Head and Neck Cancers Symposium: Pembrolizumab Plus Radiotherapy for Platinum-Ineligible Patients With Locally Advanced HNSCC
A new phase II trial has found that the combination of radiation therapy and pembrolizumab led to improved survival outcomes and acceptable toxicity for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The combination therapy may offer a new treatment option for...
FDA Approves Neratinib/Capecitabine for Pretreated Patients With Metastatic HER2-Positive Breast Cancer
On February 25, the U.S. Food and Drug Administration (FDA) approved neratinib (Nerlynx), a tyrosine kinase inhibitor, in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the...
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...
Mixed Results With Durvalumab Maintenance in HER2-Negative Advanced Breast Cancer
Given as maintenance therapy, the checkpoint inhibitor durvalumab significantly improved overall survival in patients with metastatic triple-negative breast cancer and yielded a numerical but not significant benefit as well for patients expressing programmed cell death ligand 1 (PD-L1), in...
Redefining What It Means to Have Precursor Myeloma
Studies have shown that all patients diagnosed with multiple myeloma had a preceding asymptomatic expansion of clonal plasma cells, clinically recognized as monoclonal gammopathy of undetermined significance or smoldering multiple myeloma. According to C. Ola Landgren, MD, PhD, Professor of...
Expert Point of View: Suzanne Lentzsch, MD, PhD
Suzanne Lentzsch, MD, PhD, Professor of Medicine and Director of the Multiple Myeloma and Amyloidosis Service at Columbia University, offered her thoughts on venetoclax-based regimens, such as the one described by Dr. Kaufman. “Despite tremendous progress in the treatment of multiple myeloma, the...
Neoadjuvant Cisplatin for BRCA-Mutation Carriers: Pruning the Dead Branches
At the 2019 San Antonio Breast Cancer Symposium, Nadine Tung, MD, of Beth Israel Deaconess Medical Center, presented a multisite study called INFORM, run by the Translational Breast Cancer Research Consortium.1 It compared single-agent cisplatin with a “classic” combination of doxorubicin and...
Postmenopausal Estrogen and Risk of Breast Cancer: What Is the Real Story?
I am responding to an article in the January 25, 2020, issue of The ASCO Post on the conclusion of the 19-year follow-up on the Women’s Health Initiative (WHI) presented by Rowan T. Chlebowski, MD, PhD, at the 2019 San Antonio Breast Cancer Symposium: Postmenopausal estrogen administration does not ...
BEACON-CRC: Quality of Life May Be Well Maintained With Targeted Treatment
For patients with previously treated metastatic colorectal cancer harboring BRAF V600E mutations, the phase III BEACON-CRC study showed the benefit for combining two or three targeted agents vs the standard of care.1 The study has now also shown a benefit for the triplet and doublet in maintaining ...
Highlights From ASH 2019 Included New Data in Leukemia, Lymphoma, and Multiple Myeloma
The ASH 2019 Annual Meeting & Exposition featured countless important sessions and lectures. It would be impossible to attend all the symposia, oral presentations, poster presentations, and special events. Below, we have selected some presentation highlights to supplement our coverage of the...
Pivotal Trial Evaluates Second-Generation BTK Inhibitor Alone and in Combination With Obinutuzumab for First-Line Treatment of CLL
The second-generation Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib, alone, or in combination with obinutuzumab significantly improved progression-free survival compared with a standard combination of obinutuzumab/chlorambucil in treatment-naive patients with chronic lympocytic leukemia...
