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kidney cancer
immunotherapy

KEYNOTE-564 Update Supports Benefit of Adjuvant Pembrolizumab in High-Risk Renal Cell Carcinoma

An updated analysis of the phase III KEYNOTE-564 trial continues to support the use of adjuvant pembrolizumab vs placebo in patients with renal cell carcinoma at high risk of recurrence, according to a presentation at the 2022 ASCO Genitourinary Cancers Symposium.1 At 30 months of follow-up,...

kidney cancer
immunotherapy

KEYNOTE-564: Adjuvant Pembrolizumab Extends Disease-Free Survival in High-Risk Renal Cell Carcinoma

Adjuvant pembrolizumab following surgery significantly improved disease-free survival compared with placebo among patients with high-risk clear cell renal cell carcinoma (RCC), according to the international phase III KEYNOTE-564 study presented at the Plenary session during the 2021 ASCO Annual...

kidney cancer
immunotherapy

KEYNOTE-564 Update Supports Benefit of Adjuvant Pembrolizumab in High-Risk Renal Cell Carcinoma

An updated analysis of the phase III KEYNOTE-564 trial continues to support the use of adjuvant pembrolizumab vs placebo in patients with renal cell carcinoma at high risk of recurrence, according to a presentation at the 2022 ASCO Genitourinary Cancers Symposium.1 At 30 months of follow-up,...

gynecologic cancers
immunotherapy

Lenvatinib/Pembrolizumab Improves Progression-Free and Overall Survival vs Chemotherapy in Previously Treated Advanced Endometrial Cancer

As reported in The New England Journal of Medicine by Vicky Makker, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, the phase III Study 309/KEYNOTE-775 trial has shown prolonged progression-free and overall survival with lenvatinib plus pembrolizumab vs physician’s choice of...

lymphoma
immunotherapy

Combinations Advance the Power of Pembrolizumab in Hodgkin Lymphoma

Pembrolizumab monotherapy is an established treatment strategy for relapsed or refractory classical Hodgkin lymphoma. In combination with chemotherapy, the checkpoint inhibitor is also showing value in the front-line setting and further boosting outcomes in the relapsed setting, according to...

gynecologic cancers

Robust and Durable Responses to Pembrolizumab in Patients With Previously Treated MSI-H/dMMR Endometrial Cancer

“Robust and clinically meaningfulantitumor activity,” with durable responses and “encouraging survival outcomes,” were reported among patients with previously treated microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) endometrial tumors who received pembrolizumab in the...

hematologic malignancies

Study Finds World Trade Center First Responders Have High Burden of Clonal Hematopoiesis

Scientists have determined that first responders to the World Trade Center during the September 11, 2001, terrorist attacks have increased levels of mutations that may escalate their risk for blood cancers or cardiovascular disease, according to a study published by Jasra et al in Nature Medicine....

pancreatic cancer

SBRT in Combination With Pembrolizumab/Trametinib vs Gemcitabine in Locally Recurrent Pancreatic Cancer

In a Chinese single-institution phase II trial reported in The Lancet Oncology, Zhu et al found that stereotactic body radiotherapy (SBRT) followed by pembrolizumab plus trametinib improved overall survival vs SBRT followed by gemcitabine in patients with postresection, KRAS-mutant, PD-L1–positive...

hematologic malignancies

FDA Approves Pacritinib for Adult Patients With Myelofibrosis and Thrombocytopenia

On February 28, the U.S. Food and Drug Administration (FDA) approved pacritinib (Vonjo) for the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Pacritinib is a...

lung cancer

Abemaciclib for Previously Treated Patients With p16ink4A-Deficient Mesothelioma

As reported in The Lancet Oncology by Dean A. Fennell, FRCP, and colleagues, a phase II trial (MiST2) showed the activity of abemaciclib in previously treated patients with p16ink4A-deficient malignant mesothelioma. As stated by the investigators, “Genetically stratified therapy for malignant...

breast cancer

Identifying Women With Triple-Negative Breast Cancer Who May Benefit From Pembrolizumab Plus Chemotherapy

Results of the phase III randomized KEYNOTE-355 trial showed that the addition of the PD-1 inhibitor pembrolizumab to investigator’s choice of first-line chemotherapy improved progression-free and overall survival in women with metastatic triple-negative breast cancer compared with placebo and...

gastrointestinal cancer

Pembrolizumab Plus Trastuzumab and Chemotherapy in Previously Untreated Advanced HER2-Positive Gastric Adenocarcinoma

As reported in Nature by Yelena Y. Janjigian, MD, and colleagues, the first interim analysis of the phase III KEYNOTE-811 trial has shown a significantly higher objective response rate with the addition of pembrolizumab to trastuzumab and chemotherapy in patients with previously untreated advanced ...

breast cancer
immunotherapy

KEYNOTE-522: Event-Free Survival With Neoadjuvant and Adjuvant Pembrolizumab in Triple-Negative Breast Cancer

As reported in The New England Journal of Medicine by Peter Schmid, MD, PhD, and colleagues, a preplanned interim analysis of the phase III KEYNOTE-522 trial has shown improved event-free survival with the addition of pembrolizumab to neoadjuvant chemotherapy, followed by adjuvant pembrolizumab, in ...

multiple myeloma
immunotherapy

Expert Point of View: Ajay K. Nooka, MD, MPH, FACP

Ajay K. Nooka, MD, MPH, FACP, Associate Professor in the Department of Hematology and Medical Oncology at Winship Cancer Institute, Emory University, Atlanta, commented on the promising emergence of bispecific T-cell engaging (bispecific) antibodies, as represented by studies presented at the 2021...

multiple myeloma
immunotherapy

Bispecific Antibodies With Multiple Targets Moving Forward in Multiple Myeloma

Poor outcomes are observed in patients with myeloma who are refractory to multiple classes of therapies, with the average patient experiencing disease progression in up to 6 months and living no longer than 6 to 15 months. Patients often rapidly cycle through regimens that use less effective or...

lymphoma

(My) German Hodgkin Story

Nearly 200 years ago, Thomas Hodgkin for the first time described a peculiar disease with undulating fever, enlarged lymph nodes, and a big spleen. Its nature was obscure. It was a fatal illness, affecting mainly young adults and children. In 1865, Samuel Wilks named this illness Hodgkin’s...

Hematologist and Bone Marrow Transplant Pioneer, Tahir Shamsi, MBBS, MRCPath, FRCPath, Dies at 59

Although bone marrow transplantation is routinely employed in the United States and other wealthy nations, this costly life-saving procedure has struggled to gain a foothold in many low- to moderate-income countries, where resources are triaged to make the best use of precious health-care funding. ...

legislation

President Biden Reignites Cancer Moonshot

As Vice President, in 2016, Joe Biden launched the Cancer Moonshot with the mission to accelerate the rate of progress against cancer. The cancer and patient community and medical researchers responded with energy and ingenuity. On February 2, President Biden announced the reigniting of the Cancer ...

gynecologic cancers
immunotherapy

Lenvatinib/Pembrolizumab vs Chemotherapy in Previously Treated Patients With Advanced Endometrial Cancer

As reported in The New England Journal of Medicine by Vicky Makker, MD, and colleagues, the phase III Study 309-KEYNOTE-775 trial has shown prolonged progression-free and overall survival with lenvatinib plus pembrolizumab vs physician’s choice of chemotherapy among previously treated patients with ...

skin cancer
immunotherapy

Pembrolizumab for Adjuvant Treatment of Stage IIB or IIC Melanoma

On December 3, 2021, pembrolizumab was approved for adjuvant treatment of adult and pediatric (≥ 12 years of age) patients with stage IIB or IIC melanoma following complete resection.1 Supporting Efficacy Data Approval was based on findings in the phase III, double-blind KEYNOTE-716 trial...

gastroesophageal cancer
immunotherapy

Pembrolizumab Plus Chemotherapy in Advanced Esophageal Cancer: Good News for Some, but More Work to Be Done

Multiple comparisons of traditional cytotoxic chemotherapy combinations that began decades ago led to the adoption of the platinum plus fluorouracil doublet as the standard of care for treatment of recurrent or metastatic esophageal cancer.1 Other combinations created by the addition and/or...

gynecologic cancers
immunotherapy

Pembrolizumab in Previously Treated Patients With MSI-H/dMMR Endometrial Cancer

As reported in the Journal of Clinical Oncology by David M. O’Malley, MD, and colleagues, pembrolizumab showed durable activity in a cohort of patients with microsatellite instability–high or mismatch repair–deficient (MSI-H/dMMR) advanced endometrial cancer enrolled in the multicohort KEYNOTE-158...

breast cancer

Anthracycline Plus Taxane Reduces Risk of Breast Cancer Recurrence at 10 Years

In a large patient-level meta-analysis of 16 trials, presented at the 2021 San Antonio Breast Cancer Symposium (SABCS),1 the combination of an anthracycline plus a taxane achieved a substantial 15% reduction in breast cancer recurrence at 10 years vs taxane chemotherapy alone, representing an...

immunotherapy

Is the Development of Cutaneous Immune-Related Adverse Events Correlated With Response to Immunotherapy?

Immune checkpoint inhibitors have become the standard of care for many patients with advanced cancers; however, these medications cause cutaneous adverse events in 20% to 40% of all patients who receive them. A study by Tang et al published in JAMA Dermatology indicated that these side effects may...

hepatobiliary cancer

Hepatic Arterial Infusion Chemotherapy vs Sorafenib for Advanced Hepatocellular Carcinoma

In a Chinese phase III trial (FOHAIC-1) reported in the Journal of Clinical Oncology, Lyu et al found that hepatic arterial infusion chemotherapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin; HAIC-FO) significantly prolonged overall survival vs sorafenib in patients with advanced...

lung cancer
genomics/genetics

ORIENT-31: Novel Four-Drug Regimen Evaluated in EGFR-Mutated NSCLC

A four-drug combination of the anti–PD-1 antibody sintilimab, the bevacizumab biosimilar IBI305, plus pemetrexed and cisplatin chemotherapy significantly improved progression-free survival compared with chemotherapy alone in patients with advanced nonsquamous non–small cell lung cancer (NSCLC) with ...

breast cancer
immunotherapy

Identifying Women With Triple-Negative Breast Cancer Who May Benefit From Pembrolizumab Plus Chemotherapy

Results of the phase III randomized KEYNOTE-355 trial showed that the addition of the PD-1 inhibitor pembrolizumab to investigator’s choice of first-line chemotherapy improved progression-free and overall survival in women with metastatic triple-negative breast cancer compared with placebo and...

lung cancer

Addition of First-Line Veliparib to Chemotherapy in Advanced Squamous Cell NSCLC: No Survival Benefit in Current Smokers, but Potential Benefit Among Biomarker-Selected Patients

In a phase III trial reported in the Journal of Clinical Oncology, Suresh S. Ramalingam, MD, of Winship Cancer Institute, Emory University School of Medicine, and colleagues found that the addition of the PARP inhibitor veliparib to platinum-based chemotherapy did not improve overall survival in...

leukemia
palliative care

Study Reveals Gaps in Code Status Discussions Among Patients With High-Risk AML

Oncologists and health-care professionals who treat patients with high-risk acute myeloid leukemia (AML) are missing important opportunities to have end-of-life discussions at earlier stages in the disease course, when patients are best able to discuss their options and preferences. These findings...

leukemia

Asciminib for Philadelphia Chromosome–Positive Chronic Myeloid Leukemia

On October 29, 2021, the oral kinase inhibitor asciminib was granted accelerated approval for adults with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase previously treated with at least two tyrosine kinase inhibitors and regular approval for adults with...

kidney cancer

Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma

On November 17, 2021, the immunotherapeutic agent pembrolizumab was granted approval for adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or nephrectomy and resection of metastatic lesions.1 Supporting Efficacy Data...

head and neck cancer
immunotherapy

Adding Pembrolizumab to Chemotherapy Improves Overall and Progression-Free Survival in First-Line Treatment of Advanced Esophageal Cancer

As reported in The Lancet by Jong-Mu Sun, MD, of Samsung Medical Center, Sungkyunkwan University, Seoul, and colleagues, an interim analysis in the phase III KEYNOTE-590 trial has shown that the addition of first-line pembrolizumab to chemotherapy resulted in improved overall and progression-free...

skin cancer
immunotherapy

FDA Approves Pembrolizumab for the Adjuvant Treatment of Stage IIB or IIC Melanoma

On December 3, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of adult and pediatric patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.  KEYNOTE-716 Efficacy was evaluated in KEYNOTE-716, a...

pancreatic cancer
immunotherapy

Neoadjuvant Chemoradiation Plus Pembrolizumab Shows No Effect on Tumor-Infiltrating Lymphocytes in Pancreatic Cancer

The addition of the checkpoint inhibitor pembrolizumab to neoadjuvant chemoradiation  has failed to overcome the immunosuppressive microenvironment of pancreatic cancer, according to data presented by Osama E. Rahma, MD, and colleagues at the Society for Immunotherapy of Cancer (SITC) 2021 Annual...

lymphoma

High Response Rate With Venetoclax in Previously Treated Patients With Waldenström’s Macroglobulinemia

In a phase II study reported in the Journal of Clinical Oncology, Castillo et al found that venetoclax produced a high major response rate in previously treated patients with Waldenström’s macroglobulinemia. As stated by the investigators, “BCL2 is overexpressed and confers prosurvival signaling in ...

genomics/genetics

Cancer Incidence and Patterns in Individuals With Pathogenic/Likely Pathogenic Germline TP53 Variants

In an observational cohort study reported in The Lancet Oncology, de Andrade et al identified cancer incidence and patterns in individuals meeting criteria for Li-Fraumeni syndrome on the basis of presence of pathogenic or likely pathogenic germline TP53 variants. As stated by the investigators,...

kidney cancer
immunotherapy

KEYNOTE-564 Trial: Adjuvant Pembrolizumab Improves Disease-Free Survival in High-Risk Renal Cell Carcinoma

As reported in The New England Journal of Medicine by Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, and colleagues, an interim analysis of the phase III KEYNOTE-564 trial has showed improved disease-free survival with adjuvant pembrolizumab vs placebo after nephrectomy in high-risk...

gynecologic cancers

Pembrolizumab Plus Chemotherapy With or Without Bevacizumab in First-Line Treatment of Advanced Cervical 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 13, 2021, pembrolizumab in combination with...

neuroendocrine tumors

NETTER-1 Trial: Final Overall Survival Analysis of Lu-177 Dotatate Plus Long-Acting Octreotide vs High-Dose Long-Acting Octreotide for Midgut Neuroendocrine Tumors

As reported in The Lancet Oncology by Jonathan R. Strosberg, MD, and colleagues, the final overall survival analysis of the pivotal phase III NETTER-1 trial has shown an approximate 12-month benefit with the addition of lutetium-177 (Lu-177) dotatate to long-acting octreotide in patients with...

breast cancer

Accelerated Radiation Therapies Move Forward in Early Breast Cancer

Two studies reported at the 2021 American Society for Radiation Oncology (ASTRO) Annual Meeting provide evidence in support of the use of accelerated radiation therapies as safe alternatives to standard radiotherapy options following breast-conserving surgery. The phase III MC1635 trial showed...

sarcoma

From Cancer Survivor to Citizen Astronaut

When I was diagnosed with osteosarcoma of my left femur nearly 20 years ago, I remember telling my parents that I didn’t want to die. The diagnosis was terrifying because all the people I knew who had cancer had passed away, and I thought this cancer would kill me, too. That evening, my dad went...

solid tumors
immunotherapy

Evorpacept Alone and Combined With Pembrolizumab or Trastuzumab for Advanced Solid Tumors

In the phase I ASPEN-01 study reported in The Lancet Oncology, Nehal Lakhani, MD, and colleagues found evidence of activity of the CD47-blocking protein evorpacept in combination with pembrolizumab or trastuzumab for the treatment of advanced solid tumors. As stated by the investigators, “Both...

lymphoma
immunotherapy

Newer Agents on the Horizon for Refractory or Relapsed DLBCL

Although treating patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) remains challenging, some newer therapies on the horizon offer promise, including bispecific antibodies, anti-CD47 antibodies, antibody-drug conjugates, and chimeric antigen receptor (CAR) T-cell therapy,...

covid-19

FDA Expands Eligibility for COVID-19 Vaccine Boosters

On November 19, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals aged 18 years and older after completion of primary vaccination with any ...

kidney cancer
immunotherapy

FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma

On November 17, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of disease recurrence following nephrectomy or nephrectomy and resection of metastatic lesions....

President Biden Nominates Robert M. Califf, MD, MACC, as FDA Commissioner

President Joseph Biden has nominated Robert M. Califf, MD, MACC, for the position of Commissioner of the U.S. Food and Drug Administration (FDA). Dr. Califf is an internationally recognized expert in clinical trial research, health disparities, health-care quality, and cardiovascular medicine....

supportive care
palliative care

Risks and Benefits Associated With Gastrostomy Tubes for Patients With Cancer

In a study published by Gauvin et al in JNCCN–Journal of the National Comprehensive Cancer Network, researchers examined over 200 patients with gastrostomy tubes and highlighted the need for a multidisciplinary approach to palliative care decision-making for patients with cancer. A gastrostomy tube ...

leukemia
genomics/genetics

FDA Approves Asciminib for Philadelphia Chromosome–Positive CML

On October 29, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the kinase inhibitor asciminib (Scemblix) for patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase who have been previously treated with two or more tyrosine...

sarcoma

Addition of Vincristine, Topotecan, and Cyclophosphamide to Five-Drug Interval-Compressed Chemotherapy for Ewing Sarcoma

As reported in the Journal of Clinical Oncology by Leavey et al, the phase III Children’s Oncology Group AEWS1031 trial showed no improvement in event-free or overall survival with the addition of vincristine, topotecan, and cyclophosphamide (VTC) to standard five-drug interval-compressed...

colorectal cancer

FDA Expands Cetuximab Label for Encorafenib Combination in BRAF V600E Mutation–Positive Metastatic Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has granted approval of a new indication for the EGFR inhibitor cetuximab (Erbitux) in combination with encorafenib (Braftovi) for the treatment of adults with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test,...

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