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breast cancer
immunotherapy

Addition of Pembrolizumab to Eribulin in HR-Positive, HER2-Negative Metastatic Breast Cancer

In a phase II trial reported in JAMA Oncology, Sara M. Tolaney, MD, MPH, and colleagues found that the addition of pembrolizumab to eribulin did not improve progression-free survival in women with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer. As stated by the...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

First-Line PD-1 Inhibitor With or Without Chemotherapy vs Chemotherapy Alone in Advanced Gastric Cancer: KEYNOTE-062

As reported in JAMA Oncology by Kohei Shitara, MD, and colleagues, the phase III KEYNOTE-062 trial showed no significant improvement in overall or progression-free survival with first-line pembrolizumab with or without chemotherapy vs chemotherapy alone in patients with PD-L1–positive advanced...

head and neck cancer

Addition of Debio 1143 to Cisplatin Chemoradiotherapy in Locoregionally Advanced Head and Neck Cancer

In a French Head and Neck Radiotherapy Oncology Group phase II trial reported in The Lancet Oncology, Sun et al found that the addition of Debio 1143 (a small-molecule antagonist of inhibitor of apoptosis proteins) to high-dose cisplatin chemoradiation improved locoregional disease control in...

covid-19

CDC Data Show Disproportionate COVID-19 Impact in American Indian and Alaska Native Populations

The Centers for Disease Control and Prevention (CDC) released a new study that specifically examines how COVID-19 is affecting American Indians and Alaska Natives (AI/AN), one of the racial and ethnic minority groups at highest risk from the disease. The CDC found that in 23 selected states, the...

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
genomics/genetics

PORTEC-3: Effect of Molecular Classification of Endometrial Cancer on Outcomes With Adjuvant Therapy

In a study reported in the Journal of Clinical Oncology, Alicia Léon-Castillo, MD, of Leiden University Medical Center, the Netherlands, and colleagues identified outcomes associated with molecular subgroups of patients with high-risk endometrial cancer enrolled in the PORTEC-3 trial of adjuvant...

gynecologic cancers

ASCO20: Cediranib Plus Olaparib vs Standard-of-Care Chemotherapy for Platinum-Sensitive Ovarian Cancer

Results of the NRG Oncology phase III clinical trial NRG-GY004 indicated that the addition of the investigational agent cediranib to olaparib and standard platinum-based chemotherapy did not improve progression-free survival outcomes for women with platinum-sensitive ovarian cancer; however,...

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: PRIMA Trial Reports Benefit With Niraparib Across Ovarian Cancer Subsets

In women with advanced ovarian cancer responding to first-line chemotherapy, maintenance therapy with the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib significantly reduced the risk of disease progression by 38% overall and by 60% in women with BRCA mutations. Even patients without a...

gynecologic cancers

Novel Drug Approvals and New Indications for Gynecologic Cancers

A number of new drugs and novel indications were added to the treatment armamentarium for gynecologic cancers over the past year. The U.S. Food and Drug Administration (FDA) approvals are noted here. Olaparib, PARP Inhibitor On May 8, 2020, the FDA expanded the indication of olaparib (Lynparza) to...

leukemia

Obinutuzumab, Ibrutinib, and Venetoclax in Treatment-Naive and Relapsed or Refractory Chronic Lymphocytic Leukemia

In a single-institution phase II trial reported in the Journal of Clinical Oncology, Rogers et al found that the combination of obinutuzumab, ibrutinib, and venetoclax produced high response rates in both treatment-naive and relapsed or refractory chronic lymphocytic leukemia. Study Details A total ...

skin cancer
immunotherapy

Researchers Outline Need for Evaluation of Gene-Expression Profiling in Melanoma

A consensus statement published in JAMA Dermatology by an international group of melanoma researchers evaluated the use of prognostic gene-expression profile testing to guide clinical management of melanoma.1 The group cautioned against the routine use of currently available gene-expression...

covid-19

Repurposing Drugs for the Treatment of COVID-19

A vaccine for COVID-19 is currently the Holy Grail, but even if an effective vaccine were developed on a fast-track timetable, it may be effective in only a percentage of people, judging by existing flu vaccines, which show efficacy rates of approximately 45% and vary year by year. Until we have a...

Providing Aid for Patients With Cancer Affected by the Beirut Explosion

The explosion of 2,750 metric tons of ammonium nitrate near the port of Beirut, Lebanon, on August 4 leveled whole sections of the city. The blast killed at least 200 people, injured more than 6,000, and left hundreds of thousands homeless. The blast also severely damaged Beirut’s already fragile...

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...

kidney cancer

Study Supports Pembrolizumab Plus Axitinib in Previously Untreated Advanced Renal Cell Carcinoma

Extended analysis of the phase III KEYNOTE-426 study upholds pembrolizumab plus axitinib as a preferred front-line regimen over sunitinib in patients with advanced sporadic renal cell carcinoma.1 These updated results were presented during the ASCO20 Virtual Scientific Program by Elizabeth R....

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...

prostate cancer

Addition of Apalutamide to Androgen-Deprivation Therapy in Metastatic Castration-Sensitive Prostate Cancer

As reported in The New England Journal of Medicine by Kim N. Chi, MD, of BC Cancer and Vancouver Prostate Centre, and colleagues, the first analysis of the phase III TITAN trial has shown that the addition of apalutamide to androgen-deprivation therapy improved radiographic progression-free and...

prostate cancer

Lutetium-177–Labeled PSMA-617 Improves PSA Response in First Analysis From TheraP Trial in Metastatic Prostate Cancer

Initial results of the randomized phase II TheraP trial showed that therapy directed to prostate-specific membrane antigen (PSMA) with lutetium-177–labeled PSMA-617 (LuPSMA) significantly improved prostate-specific antigen (PSA) response compared with cabazitaxel in men with metastatic...

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 ...

gynecologic cancers

Effect of Molecular Classification of Endometrial Cancer on Adjuvant Therapy Outcomes

In a study reported in the Journal of Clinical Oncology, Léon-Castillo et al identified outcomes associated with molecular subgroups of patients with high-risk endometrial cancer enrolled in the PORTEC-3 trial of adjuvant chemoradiotherapy vs radiotherapy alone. Study Details The study involved...

skin cancer

Pembrolizumab for Cutaneous Squamous Cell Carcinoma

On June 24, 2020, pembrolizumab was approved for treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.1,2 Supporting Efficacy Data Approval was based on findings in the multicenter, multicohort, open-label KEYNOTE-629 trial ...

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,...

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...

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...

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...

colorectal cancer

Second-Look Surgery Plus HIPEC vs Surveillance for Patients at High Risk for Colorectal Peritoneal Metastases

In a French phase III trial (PROPHYLOCHIP–PRODIGE 15) reported in The Lancet Oncology, Goéré et al found that second-look surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) did not improve disease-free survival vs standard surveillance in patients at high risk of developing colorectal...

leukemia

Sorafenib Maintenance After Allogeneic HCT in Patients With FLT3-ITD–Positive AML

In the German-Austrian phase II SORMAIN trial reported in the Journal of Clinical Oncology, Burchert et al found that maintenance treatment with sorafenib vs placebo was associated with significantly prolonged relapse-free survival after allogeneic hematopoietic stem cell transplantation (HCT) in...

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...

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...

covid-19
solid tumors
hematologic malignancies

In Case You Missed It: Quick Takes on Novel Therapies for Solid and Hematologic Malignancies

Because of the COVID-19 pandemic, oncology providers from around the world had to forgo their annual trip to McCormick Place—but the show did go on. We all realized important research can still be presented, clinicians and fellow researchers will still listen, and ASCO presentations will still...

ASTRO to Host Virtual Annual Meeting, October 25–28, 2020

The American Society for Radiation Oncology (ASTRO) has announced it will hold its 62nd Annual Meeting October 25–28, 2020, via an interactive virtual platform. The meeting, “Global Oncology: Radiation Therapy in a Changing World,” will feature reports from the latest clinical trials; panels on...

pancreatic cancer

First-Line FOLFIRINOX vs Gemcitabine/Nab-paclitaxel for Localized Pancreatic Cancer

In a single-institution retrospective study reported in JAMA Surgery, Perri et al found that first-line FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) was associated with a higher response rate and subsequent pancreatectomy vs gemcitabine plus nab-paclitaxel in patients with...

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....

lung cancer

Nivolumab Plus Ipilimumab in Two New Lung Cancer Indications

The combination of nivolumab and ipilimumab was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with non–small cell lung cancer (NSCLC) in two different regimens: On May 15, 2020, the two-drug combination was approved for first-line treatment in...

skin cancer
immunotherapy

Longer-Term Results of Pivotal Study in Advanced Cutaneous Squamous Cell Carcinoma

New, longer-term data from a pivotal phase II trial in advanced cutaneous squamous cell carcinoma (CSCC), were presented during the ASCO20 Virtual Scientific Program and discussed during a poster discussion.1 Danny Rischin, MD, of the Peter MacCallum Cancer Centre, Victoria, Australia, presented...

lymphoma
immunotherapy

Pembrolizumab Improves Progression-Free Survival vs Brentuximab Vedotin in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma

Treatment with the anti–PD-1 agent pembrolizumab significantly improved progression-free survival in patients with classical Hodgkin lymphoma compared with standard brentuximab vedotin, according to results of the phase III KEYNOTE-204.1 The study results were presented during the ASCO20 Virtual...

colorectal cancer
immunotherapy

Rates of Progression-Free Survival in MSI-H/dMMR Metastatic Colorectal Cancer Doubled by Pembrolizumab

Upfront treatment with immunotherapy not only improved results in a subset of patients with metastatic colorectal cancer, it doubled the rates of median progression-free survival. These findings—the first of their kind—arose from the interim analysis of the randomized open-label phase III...

gastrointestinal cancer
immunotherapy

Lenvatinib Plus Pembrolizumab for Advanced Gastric Cancer

In the Japanese single-center phase II EPOC1706 trial reported in The Lancet Oncology, Kawazoe et al found high objective response among patients with advanced gastric cancer who received the combination of lenvatinib and pembrolizumab as first- or second-line treatment. Study Details The trial...

gastrointestinal cancer
immunotherapy

Lenvatinib Plus Pembrolizumab for Advanced Gastric Cancer

In the Japanese single-center phase II EPOC1706 trial reported in The Lancet Oncology, Kawazoe et al found high objective response among patients with advanced gastric cancer who received the combination of lenvatinib and pembrolizumab as first- or second-line treatment. Study Details The trial...

kidney cancer

Study Supports Pembrolizumab Plus Axitinib in Previously Untreated Advanced Renal Cell Carcinoma

Extended analysis of the phase III KEYNOTE-426 study upholds pembrolizumab plus axitinib as a preferred front-line regimen over sunitinib in patients with advanced sporadic renal cell carcinoma.1 These updated results were presented at the ASCO20 Virtual Scientific Program by Elizabeth R. Plimack,...

colorectal cancer
immunotherapy

FDA Approves Pembrolizumab for the First-Line Treatment of MSI-H/dMMR Colorectal Cancer

On June 29, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer. KEYNOTE-177 Approval was based on...

lung cancer
covid-19

Mortality Risk in Patients With COVID-19 and Thoracic Malignancies: Initial Report From the TERAVOLT Registry Study

As reported in The Lancet Oncology by Marina C. Garassino, MD, and colleagues, initial findings from the Thoracic Cancers International COVID-19 Collaboration (TERAVOLT) registry study have identified potential factors associated with increased risk of mortality in patients infected with COVID-19...

bladder cancer
immunotherapy

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

As reported in the Journal of Clinical Oncology by Vuky et al, 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 metastatic urothelial cancer, with higher response rates and longer survival in...

lung cancer

Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation

On May 6, 2020, the oral mesenchymal-epithelial transition (MET) kinase inhibitor capmatinib was granted accelerated approval for the treatment of adult patients who have metastatic non–small cell lung cancer (NSCLC) with tumors that have a mutation that leads to MET exon 14 skipping, as detected...

issues in oncology

ASCO20 Virtual Scientific Program: Next-Generation Oncology Highlights

The ASCO20 Virtual Scientific Program was different in many ways, not only because of the virtual modality forced by the COVID-19 pandemic, but also because of the resilience of the scientific society and my colleagues around the world. I’m in the plenary session of the ASCO 2025 Annual Meeting....

prostate cancer

Olaparib for Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer

On May 19, 2020, olaparib was approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer who experienced disease progression after treatment with...

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