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Showing 3751 - 3800FDA Awards Six Grants to Fund New Clinical Trials of Medical Products for Treatment of Rare Diseases
The U.S. Food and Drug Administration (FDA) announced it has awarded six new clinical trial research grants to principal investigators from academia and industry, totaling more than $16 million over the next 4 years. These grants, awarded through the Congressionally funded Orphan Products Grants...
Expert Point of View: Chiara Cremolini, MD, PhD
The KEYNOTE-177 invited discussant, Chiara Cremolini, MD, PhD, of the University of Pisa, Italy, welcomed the patient-reported outcomes of the study, noting that such data are frequently missing. “Unfortunately, quality of life is an often-disregarded issue in colorectal cancer clinical trials,”...
First-Line Pembrolizumab in Metastatic Colorectal Cancer: Quality of Life Also Improved
In KEYNOTE-177, the anti–PD-L1 antibody pembrolizumab reduced the risk of disease progression by 40% vs chemotherapy in a targeted subset of previously untreated patients with metastatic colorectal cancer. Now, in terms of health-related quality of life, pembrolizumab is also the clear favorite,...
Ipatasertib/Abiraterone Combination Shows Potential in Metastatic Castration-Resistant Prostate Cancer With PTEN Loss
Ipatasertib plus abiraterone plus prednisone achieved significantly superior radiographic progression–free survival and antitumor activity compared with placebo plus abiraterone plus prednisonein patients with metastatic castration-resistant prostate cancer and PTEN loss, according to the results...
Olaparib Improves Outcomes in Metastatic Castration-Resistant Prostate Cancer With BRCA1/2 Alterations
The PARP inhibitor olaparib reduced the risk of death by 31% compared with a second hormonal treatment (enzalutamide or abiraterone) in men with metastatic castration-resistant prostate cancer characterized by BRCA1, BRCA2, or ATM mutations, in the final analysis of the phase III PROfound trial...
Early-Phase Study Reports Progress in Targeting KRAS-Mutated Tumors With Sotorasib
Although KRAS is one of the most frequently mutated oncogenes in human cancers, an almost 4-decade long search for drugs that hit this target has been elusive—until now. Sotorasib (formerly called AMG-510), a small-molecule inhibitor of the KRAS G12C mutation, demonstrated clinical activity and...
EMPOWER-Lung 1 Trial: Cemiplimab Improves Survival Over Chemotherapy in Advanced NSCLC
The European Society for Medical Oncology (ESMO) Virtual Congress 2020 presented several abstracts with good news for patients with lung cancer. Long-term follow-up of immunotherapies showed excellent survival, a promising new ALK inhibitor improved outcomes compared with the standard of care, the...
Co-Leader of Immunotherapy Trial Reflects on ‘Practice-Changing’ Results in Advanced Bladder and Other Urinary Tract Cancers
In a large, randomized clinical trial, researchers evaluated the immunotherapy drug avelumab for patients with advanced urothelial cancer. The findings of the trial, called the JAVELIN Bladder 100 study, are “very exciting,” even “practice-changing,” said the trial’s co-leader, Petros Grivas, MD,...
Expert Point of View: Sjoukje Oosting, MD, PhD
Invited discussant of the xevinapant study, Sjoukje Oosting, MD, PhD, of the University Medical Center Groningen, the Netherlands, commented: “There is finally hope on the horizon that we can increase the cure rate of our patients with head and neck cancer, if these data are confirmed in a phase...
Novel IAP Blocker Plus Chemoradiotherapy Improved Outcomes in Head and Neck Cancer Trial
Xevinapant, an investigational inhibitor of apoptosis proteins (IAP) blocker, prolonged overall survival when added to standard chemoradiotherapy for locally advanced head and neck squamous cell carcinoma, according to an updated analysis of a randomized, placebo-controlled phase II study presented ...
Expert Point of View: Fatima Cardoso, MD
The encouraging results of the phase III ASCENT trial suggest that sacituzumab govitecan has clearly earned a place in the treatment algorithm for advanced triple-negative breast cancer, said the study’s invited discussant, Fatima Cardoso, MD, Director of the Breast Unit at the Champalimaud...
Sacituzumab Govitecan Yields Survival Benefit as Third-Line Treatment in Triple-Negative Breast Cancer: ASCENT Trial
Based on results from a phase I/II clinical trial, the antibody drug conjugate sacituzumab govitecan was recently granted accelerated approval in the treatment of patients with advanced triple-negative breast cancer, contingent on a larger study confirming its benefit. The confirmatory phase III...
Should Body Mass Index Guide the Choice of Chemotherapy in Patients With Breast Cancer?
The rate of obesity is rising dramatically in the United States and Europe, with more than 60% of women in the United States1,2 and 50% of women in Europe3 classified as overweight or obese based on their body mass index (BMI). Obesity is associated with an increased risk of hormone...
Lorlatinib Improves Outcomes Over Crizotinib in First-Line Setting of ALK-Positive NSCLC: CROWN Trial
Lorlatinib significantly improved progression-free survival compared with crizotinib in the first-line treatment of patients with advanced ALK-positive non–small cell lung cancer (NSCLC), according to a planned interim analysis of the phase III CROWN trial presented at the European Society for...
FDA Pipeline: Priority Reviews in EGFR-Mutant Lung Cancer, Advanced Renal Cell Carcinoma; Fast Track Designations in CLL and Solid Tumors
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for EGFR-mutant lung cancer and advanced renal cell carcinoma; granted Fast Track designation to agents in chronic lymphocytic leukemia (CLL) and locally advanced or metastatic solid tumors; and more....
Surufatinib in Advanced Pancreatic Neuroendocrine Tumors
As reported in The Lancet Oncology by Xu et al, the Chinese phase III SANET-p trial has shown significantly improved progression-free survival with surufatinib vs placebo in patients with advanced pancreatic neuroendocrine tumors. Surufatinib is a novel small-molecule inhibitor that targets...
Adjuvant vs Salvage Radiotherapy Plus Short-Term ADT After Radical Prostatectomy for Localized Prostate Cancer
As reported in The Lancet Oncology by Sargos et al, the French phase III GETUG-AFU 17 trial has shown no event-free survival benefit for adjuvant radiotherapy vs salvage radiotherapy—both with short-term androgen-deprivation therapy (ADT)—after radical prostatectomy in men with localized prostate...
Do Patients With Early-Stage NSCLC Have a Higher Tumor Mutational Burden Than Those With More Advanced Disease?
The tumors of patients with stage I and II non–small cell lung cancer (NSCLC) demonstrated a generally higher tumor mutational burden and more often displayed the mutational signature associated with tobacco smoking than those of patients with more advanced disease, according to findings presented...
ASTRO Issues Clinical Guideline on Radiation Therapy for Rectal Cancer
A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance for physicians who use radiation therapy to treat patients with locally advanced rectal cancer. Recommendations outline indications and best practices for pelvic radiation treatments, as well as the...
Are Delays in Breast Cancer Treatment as Harmful as Commonly Thought?
Delays in the treatment of breast cancer matter, but not as much “as we and our patients typically assume,” Richard J. Bleicher, MD, FACS, informed participants at the 22nd Annual Lynn Sage Breast Cancer Symposium.1 Some of these delays are unavoidable and others are tradeoffs that must be made to...
Final Efficacy Results From the ExteNET Trial: Neratinib in Pretreated Patients With HR-Positive, HER2-Positive Early Breast Cancer
In an analysis from the phase III ExteNET trial reported in Clinical Breast Cancer, Arlene Chan, MD, and colleagues found significant improvements in efficacy outcomes with the administration of neratinib vs placebo starting at 1 year or sooner after neoadjuvant/adjuvant trastuzumab-based therapy...
Adjuvant Sorafenib vs Placebo in Patients With Kidney Cancer at Intermediate or High Risk of Relapse
In the phase III SORCE trial reported in the Journal of Clinical Oncology, Eisen et al found no benefit of sorafenib vs placebo as adjuvant therapy in patients with renal cell carcinoma at intermediate or high risk of disease recurrence. Study Details The double-blind trial included 1,711 patients...
Sentinel Node Biopsy vs Neck Node Dissection in Operable Oral or Oropharyngeal Cancer: Equivalence Trial
In a French phase III trial (Senti-MERORL) reported in the Journal of Clinical Oncology, Garrel et al found that sentinel node biopsy demonstrated oncologic equivalance to neck lymph node dissection in 2-year neck node recurrence–free survival in patients with operable cT1–T2N0 oral/oropharyngeal...
Adjuvant vs Early Salvage Radiotherapy After Radical Prostatectomy in High-Risk Prostate Cancer
In a phase III noninferiority trial (RAVES) reported in The Lancet Oncology, Kneebone et al found that salvage radiotherapy did not meet noninferiority criteria for biochemical progression vs adjuvant radiotherapy, but was associated with nearly identical biochemical control rates and reduced...
Expert Point of View: Rodabe N. Amaria, MD
The value of adjuvant therapy for patients with resected stage III or IV melanoma—in the form of pembrolizumab and nivolumab—continues to be observed after approximately 4 years from the start of therapy, according to Rodabe N. Amaria, MD, Associate Professor of Melanoma Medical Oncology at The...
Long-Term Benefit of Adjuvant Immunotherapy Sustained in Stage III or IV Melanoma
The benefit of anti–PD-1 antibodies in the adjuvant treatment of patients with stage III or stage IV melanoma continues to be observed at around 4 years for both pembrolizumab and nivolumab, according to updates of pivotal trials presented at the European Society for Medical Oncology (ESMO) Virtual ...
Ixazomib Maintenance in Newly Diagnosed Patients With Multiple Myeloma Not Undergoing Stem Cell Transplant: TOURMALINE-MM4 Trial
As reported in the Journal of Clinical Oncology by Meletios A. Dimopoulos, MD, and colleagues, the phase III TOURMALINE-MM4 trial has shown that postinduction maintenance with ixazomib prolonged progression-free survival vs placebo in patients with newly diagnosed multiple myeloma not undergoing...
Addition of Oxaliplatin to Preoperative Capecitabine-Based Chemoradiation and Adjuvant Capecitabine in Locally Advanced Rectal Cancer
As reported in the Journal of Clinical Oncology by Schmoll et al, the phase III PETACC 6 trial has shown no benefit of the addition of preoperative and adjuvant oxaliplatin to preoperative capecitabine-based chemoradiation and adjuvant capecitabine in patients undergoing total mesorectal excision...
Expert Point of View: Bartosz Chmielowski, MD, PhD
COMBI-i’s invited discussant, Bartosz Chmielowski, MD, PhD, Associate Clinical Professor at the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, said this study is one of three key trials in which checkpoint inhibitors were combined with BRAF and MEK inhibitors. “This is...
COMBI-i Trial: No Statistical Benefit to Adding Spartalizumab to Dabrafenib/Trametinib in Melanoma
Patients with unresectable or metastatic melanoma harboring BRAF V600 mutations did not benefit from the addition of the anti–PD-1 antibody spartalizumab to dabrafenib and trametinib in the COMBI-i trial, which was presented at the European Society for Medical Oncology (ESMO) Virtual Congress...
FDA Extends the Approval of Pembrolizumab for Patients With Classical Hodgkin Lymphoma
On October 14, the U.S. Food and Drug Administration (FDA) extended the approval of pembrolizumab (Keytruda) for the following indications: Adult patients with relapsed or refractory classical Hodgkin lymphoma Pediatric patients with refractory classical Hodgkin lymphoma or classical Hodgkin...
Clinical Challenges of Managing Breast Cancer Brain Metastases
“Breast cancer brain metastases are a clinical challenge that are only increasing in incidence and are a consequence of advanced breast cancers, largely HER2-positive and triple-negative,” according to Carey K. Anders, MD, Professor of Medicine and Medical Director of the Duke Brain and Spine...
KEYNOTE-181 Trial: Second-Line Pembrolizumab vs Chemotherapy in Advanced Esophageal Cancer
As reported in the Journal of Clinical Oncology by Takashi Kojima, MD, and colleagues, the phase III KEYNOTE-181 trial has shown that second-line pembrolizumab improved overall survival vs investigator’s choice of chemotherapy in patients with advanced or metastatic esophageal cancer with a PD-L1...
Prognostic Model for Outcomes With Ibrutinib Treatment for Chronic Lymphocytic Leukemia
As reported in the Journal of Clinical Oncology, Ahn et al developed a four-factor model that identified risk groups for poorer outcomes among patients treated with ibrutinib for chronic lymphocytic leukemia. Study Details Patients treated with ibrutinib in phase II and III trials constituted the...
Biochemical Progression-Free Survival With Adjuvant vs Salvage Radiotherapy After Radical Prostatectomy: RADICALS-RT Trial
As reported in The Lancet by Christopher C. Parker, MD, and colleagues, initial findings in the phase III RADICALS-RT trial have shown no biochemical progression-free survival benefit and no difference in freedom from nonprotocol hormone therapy with adjuvant radiotherapy vs salvage radiotherapy...
Addition of Nivolumab to Neoadjuvant Chemotherapy in Resectable Stage IIIA NSCLC
In the Spanish phase II NADIM trial reported in The Lancet Oncology, Provencio et al found that the addition of nivolumab to neoadjuvant chemotherapy and the use of adjuvant nivolumab were associated with high 24-month rates of progression-free survival in patients with resectable stage IIIA...
Art of Oncology: On the Page and in a Podcast, Personal Reflections From Oncologists Are a Fitting Companion Amid the COVID-19 Pandemic
The well-loved Art of Oncology section of the Journal of Clinical Oncology (JCO) and its pioneering podcast are both resonating as never before, as cancer specialists are prompted into deeper reflections about the poignant moments that give life meaning by the COVID-19 pandemic. JCO’s Art of...
Addition of Veliparib to Carboplatin/Paclitaxel in BRCA-Mutated Advanced Breast Cancer
As reported in The Lancet Oncology by Véronique Diéras, MD, of the Institut Curie, Paris, and Centre Eugène Marquis, Rennes, and colleagues, the phase III BROCADE3 trial has shown a significant improvement in progression-free survival with the addition of the poly (ADP-ribose) polymerase (PARP)...
Addition of Nelarabine to Standard Therapy Improves Disease-Free Survival in Newly Diagnosed T-Cell ALL
As reported in the Journal of Clinical Oncology by Kimberly P. Dunsmore, MD, of the Virginia Tech Carilion School of Medicine and Carilion Clinic, Roanoke, and colleagues, the phase III Children’s Oncology Group AALL0434 trial has shown that the addition of nelarabine to standard therapy improved...
Expert Point of View: Elizabeth Smyth, MD
The overall survival benefit for PD-L1 CPS ≥ 5 tumors in CheckMate 649 is a game-changer. An oxaliplatin doublet plus chemotherapy should become a standard of care for these patients,” according to Elizabeth Smyth, MD, an oncology consultant at Cambridge University Hospital NHS Foundation Trust in...
Nivolumab Plus Chemotherapy: New Standard of Care in Advanced Gastric Cancer?
As first-line treatment for advanced gastric cancer, nivolumab plus chemotherapy leads to significantly improved progression-free and overall survival over chemotherapy alone, investigators reported during a Presidential Symposium of the European Society for Medical Oncology (ESMO) Virtual Congress ...
Carfilzomib and Daratumumab With Dexamethasone for Relapsed or Refractory Multiple Myeloma
On August 20, 2020, carfilzomib and daratumumab were approved for use in combination with dexamethasone for treatment of adults with relapsed or refractory multiple myeloma who have received one to three lines of therapy.1-3 Supporting Efficacy Data Approval was based on findings in two clinical...
Impact of Adjuvant Osimertinib on CNS Recurrence of NSCLC: ADAURA Trial
Osimertinib significantly prolonged disease-free survival compared with placebo in patients with completely resected stage II to IIIA non–small cell lung cancer (NSCLC), according to the results of the large randomized phase III ADAURA trial presented at the European Society for Medical Oncology...
Study Questions Role of Routine Postoperative Radiotherapy in NSCLC With Mediastinal Nodes
The Lung ART trial was designed to demonstrate whether there is any benefit to the routine use of modern mediastinal postoperative radiotherapy in patients with non–small cell lung cancer (NSCLC) stage IIIA N2 (ie, patients with mediastinal nodal involvement) following complete resection and neo...
First-Line Nivolumab Plus Cabozantinib Improves Outcomes vs Sunitinib in Advanced Renal Cell Carcinoma
The combination of nivolumab plus cabozantinib was found to be superior to the former standard, sunitinib, in the first-line treatment of advanced or metastatic renal cell carcinoma, according to the results of the phase III CheckMate 9ER trial reported at the European Society for Medical Oncology...
Expert Point of View: George W. Sledge, Jr, MD
The results of monarchE were discussed by George W. Sledge, Jr, MD, Professor of Medicine and Chief of Oncology at Stanford University Medical Center, who offered some possibilities as to why its results were positive and those for palbociclib, in the phase III PALLAS trial, were “resoundingly...
Addition of Abemaciclib to Endocrine Therapy Reduces Recurrence in Early Breast Cancer
For the first time, an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) has reduced the risk of invasive disease recurrence in patients with early breast cancer when combined with standard endocrine therapy, investigators reported at the European Society for Medical Oncology (ESMO) Virtual...
Phase III NALA Trial Meets Primary Endpoint in Previously Treated HER2-Positive Breast Cancer
As reported in the Journal of Clinical Oncology by Cristina Saura, MD, of Vall d’Hebron University Hospital, Barcelona, and colleagues, the phase III NALA trial has shown significantly prolonged progression-free survival with the irreversible pan-HER tyrosine kinase inhibitor neratinib plus...
Tucatinib Combination Extends Survival in HER2-Positive Metastatic Breast Cancer, Including Patients With Brain Metastases
For patients with progressing HER2-positive metastatic breast cancer previously treated with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1), no single regimen is an established standard of care. More than 50% of these patients will develop brain metastasis, and thus far, treatments...
Wesley Family Donates $10 Million to Seidman Cancer Center
In honor of a transformational $10 million gift from Kimberly and Joseph Wesley, University Hospitals is establishing the Wesley Center for Immunotherapy at University Hospitals (UH) Seidman Cancer Center in Cleveland. This gift will further enable physician-scientists to engage in groundbreaking...
