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

The FDA has approved pembrolizumab (Keytruda®, Merck), a programmed death cell death protein 1 (PD-1)–blocking antibody, for the adjuvant treatment of adult and pediatric patients 12 years and older with stage IIB or IIC melanoma following complete resection. "Current standard of care for patients after resection of high-risk stage II melanoma is observation," wrote Jason Luke, MD, Director of the Cancer Immunotherapeutics Center in the Division of Hematology/Oncology at the University of Pittsb...

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Utilizing Biomarker Testing to Improve Lung Cancer Survival: Beth Sandy, MSN, CRNP

The survival rate for lung cancer has improved significantly in recent years, largely due to the adoption of biomarker testing and the development of targeted therapies. In this interview in honor of Lung Cancer Awareness Month, Beth Sandy, MSN, CRNP, Outpatient Thoracic Oncology Nurse Practitioner at the University of Pennsylvania Abramson Cancer Center, discusses the importance of utilizing biomarker testing in order to determine treatment options for patients with lung cancer. Oncology Data A...

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Improving the Management of Metastatic Breast Cancer: A Conversation With Dr. Sara Tolaney

· Keira Smith: Welcome to Oncology Data AdvisorTM, where we explore the latest advances in cancer research and treatment. I'm Keira Smith. In this podcast, Dr. Sara Tolaney from Dana-Farber Cancer Institute will be discussing strategies for improving the management of patients with metastatic breast cancer. Thank you for joining us, Dr. Tolaney. Sara Tolaney, MD, MPH: Thanks so much for having me. I'm Sara Tolaney. I'm a breast medical oncologist at Dana-Farber Cancer Institute here in Bo...

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Atezolizumab Indication Withdrawn from Triple-Negative Breast Cancer Treatment

In consultation with the FDA, the accelerated approval of atezolizumab (Tecentriq®, Genentech) in combination with nab-paclitaxel has been voluntarily withdrawn from the treatment of patients with programmed death ligand 1 (PD-L1)–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). "Triple-negative breast cancer is a heterogenous disease entity with a high unmet medical need," wrote David Miles, MD, Lead Clinician for Breast Cancer at Mount Vernon Cancer Ce...

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Improving the Management of Metastatic Breast Cancer: A Conversation With Dr. Sara Tolaney

Keira Smith: Hi, I'm Keira Smith from Oncology Data AdvisorTM. I'm here today with Dr. Sara Tolaney. Sara Tolaney, MD, MPH: Thanks so much for having me. I'm Sara Tolaney. I'm a breast medical oncologist at Dana-Farber Cancer Institute here in Boston. Keira Smith: Thank you so much for joining us, Dr. Tolaney. So what are some of the most challenging aspects of managing patients with metastatic breast cancer? Dr. Tolaney: I think we've made incredible progress for our patients with metastatic br...

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New Pembrolizumab Indications Approved for Triple-Negative Breast Cancer

The FDA has granted approval to pembrolizumab (Keytruda®, Merck) for patients with high-risk early-stage triple-negative breast cancer (TNBC) as neoadjuvant treatment in combination with chemotherapy and as single-agent adjuvant treatment following surgery. In addition, the FDA has confirmed the November 2020 accelerated approval of pembrolizumab in combination with chemotherapy for patients with locally recurrent unresectable or metastatic TNBC with a programmed death ligand 1 (PD-L1) combined ...

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Challenges and New Developments in Metastatic Colorectal Cancer With Tanios Bekaii-Saab, MD

Despite the many obstacles associated with treating and managing patients with metastatic colorectal cancer, the ongoing study of several novel agents has the potential to significantly improve the outcomes of these patients in the coming years. In this interview, Tanios Bekaii-Saab, MD, Professor of Medicine at the Mayo Clinic Cancer Center in Phoenix, Arizona, discusses strategies to optimize the management of metastatic colorectal cancer and the promising developments which may advance treatm...

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Exploring Immunotherapy for the Treatment of Merkel Cell Carcinoma: Shailender Bhatia, MD, and Ciara Kelly, MBBCh, BAO

Merkel cell carcinoma is a skin cancer where the Merkel cells grow out of control. In this excerpt of the transcript from their continuing medical education/nursing continuing professional development (CME/NCPD)–approved activity, Update on Immunotherapeutic Strategies for Advanced Merkel Cell Carcinoma, Shailender Bhatia, MD, Associate Professor at the University of Washington School of Medicine, and Ciara Kelly, MBBCh, BAO, Assistant Attending Physician at Memorial Sloan Kettering Cancer Cente...

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Adjuvant Nivolumab Approved for Resected Esophageal and GEJ Cancer

The FDA has granted approval to nivolumab (Opdivo®, Bristol Myers Squibb) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease after prior neoadjuvant chemoradiotherapy. "No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer," wrote the investigators of the phase 3 CheckMate 577 trial...

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Dostarlimab-gxly Approved for Recurrent/Advanced Endometrial Cancer

The FDA has granted accelerated approval to dostarlimab-gxly (Jemperli®, GlaxoSmithKline) for patients with mismatch repair deficient recurrent or advanced endometrial cancer that has progressed on or after a prior platinum-containing chemotherapy. "The prognosis for patients with a diagnosis of advanced or recurrent endometrial cancer is poor, and, to our knowledge, there are no accepted consensus-based guidelines for standard of care after the disease progresses while undergoing or after treat...

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FDA Approves Sacituzumab Govitecan for Advanced Urothelial Cancer

Sacituzumab govitecan (Trodelvy®, Immunomedics) has been granted accelerated approval for patients with locally advanced or metastatic urothelial cancer following treatment with platinum–containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitor. "Patients with metastatic urothelial cancer have limited options after progression on platinum and checkpoint inhibitors," wrote the investigators of the phase 2 TROPHY-U-01 study (NCT03547973), on w...

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Cemiplimab Approval for Locally Advanced/Metastatic Basal Cell Carcinoma

Recently, the FDA granted approval to cemiplimab (Libtayo®, Regeneron Pharmaceuticals) for the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC) who were previously treated with a hedgehog pathway inhibitor (HHI) or who are ineligible for HHI therapy. In this interview, Karl Lewis, MD, Professor of Medical Oncology at the University of Colorado Anschutz Medical Campus and one of the investigators of Study 1620 (NCT03132636), on which the approval was based, spe...

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Cemiplimab-rwlc Approved for Non-Small Cell Lung Cancer With High PD-L1 Expression

The FDA has approved cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.), a programmed cell death protein 1 (PD-1) inhibitor, for the first-line treatment of patients with advanced non-small lung cancer cell (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in at least 50% of their cells and whose tumors do not have aberrations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or C-ROS oncogene 1 (ROS1). "An estimated 25% to 35% of advanced NSCLC ...

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Pembrolizumab Approved for Classical Hodgkin Lymphoma

PembrolizumabThe FDA has now expanded the approved indications for pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme) to include both adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and pediatric patients with refractory cHL, or cHL that has relapsed after two or more lines of therapy. The approval was based on efficacy data from the open-label phase 3 KEYNOTE-204 trial (NCT02684292), for which 304 adult patients with cHL previously treated with at least one multiagen...

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Nivolumab/Ipilimumab Approved: Malignant Pleural Mesothelioma

The FDA has now approved nivolumab (Opdivo®, Bristol Myers Squibb) in combination with ipilimumab (Yervoy®, Bristol-Myers Squibb) as first-line treatment for unresectable malignant pleural mesothelioma (MPM). This therapeutic combination is only the second treatment to be FDA approved for this condition, and it marks the first mesothelioma approval to take place in the past 16 years. The approval was based on efficacy data from the open-label phase 3 CHECKMATE 743 trial (NCT02899299), ...

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Delivering Immunotherapeutics Intratumorally: Safe for Treating Cancer?

Intravenous administration of chemotherapy is the conventional method of delivery. However, several issues arise with this method, including insufficient drug penetration into the tumor tissue. Intratumoral injections of immunotherapies directly into the tumor have been a possible solution to this problem, and, according to a recent study, results of which are published in JAMA Network Open, this technique has been found to be a viable option for a variety of histological conditions and target o...

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Pembrolizumab Approved: Solid Tumors With High Tumor Mutational Burden

The FDA granted accelerated approval to pembrolizumab (Keytruda®, Merck) for adults and children with previously treated unresectable or metastatic tumor mutational burden (TMB)–high solid tumors, defined as tumors with at least 10 mutations per megabase, who have no satisfactory alternative treatment option. The FDA also approved the FoundationOne® CDx assay (Foundation Medicine) as the companion diagnostic used to determine treatment eligibility. The approval was based on data from a prospecti...

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Denosumab Effective for Giant-Cell Tumor of Bone

According to a recent phase 2 study, denosumab is an effective treatment for patients with giant-cell tumor of bone (GCTB). In this study, results of which are published in The Lancet Oncology, 532 adult and skeletally mature adolescent patients with histologically confirmed and radiographically measurable GCTB were enrolled. In order to be eligible, participants had to be at or above the age of 12 years, weigh at least 45 kg, have a Karnofsky performance status of 50% or higher (Eastern Coopera...

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Durvalumab Plus Platinum/Etoposide for Extensive-Stage SCLC: Luis Paz-Ares, MD

Because most patients with small-cell lung cancer (SCLC) present with extensive-stage disease—in which the cancer has spread to both lungs or throughout the body—survival rates are poor, and there is a need to develop alternative treatments to improve outcomes. In their study now published in The Lancet, Luis Paz-Ares, MD, and colleagues found that in patients with extensive-stage SCLC (ES-SCLC), the addition of the immunotherapy drug durvalumab to a chemotherapy regimen of platinum/etoposide si...

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Why Do Pre-Immunotherapy Antibiotics Reduce Survival? With David J. Pinato, MD, MRes, PhD

​Many patients with cancer experience infections requiring treatment. However, David Pinato, MD, MRes, PhD, and colleagues recently found that in patients with non-small cell lung cancer (NSCLC), melanoma, and other tumor types, broad-spectrum antibiotic treatment administered within 30 days prior to the commencement of immune checkpoint inhibitor therapy dramatically worsened overall survival (2 vs 26 months) and increased the risk of treatment-refractory disease. In this interview with i3 Heal...

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