(Press-News.org) The Alliance for Clinical Trials in Oncology today announced detailed results will be presented at ESMO 2023 from CABINET (A021602), a phase III pivotal trial evaluating cabozantinib compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors (pNET) and a second cohort of patients with advanced extra-pancreatic NET (epNET). The study met the primary objective for each cohort, demonstrating that cabozantinib provided dramatic improvements in median progression-free survival (PFS) for the patients in the pNET and epNET cohorts. The data are being presented today at 2:30 am ET/8:30 am CEST during the Proffered Paper Session – NETs and Endocrine Tumours at the 2023 European Society of Medical Oncology (ESMO) Congress (LBA53) by Alliance Study Chair Jennifer Chan, MD, MPH.
“Although progress has been made in recent years, there remains a critical need for new and effective therapies for patients with advanced neuroendocrine tumors. Given that there is no standard treatment for patients with progressive disease, these results showing notable improvements in progression-free survival are highly encouraging for patients and their physicians,” said Dr. Chan, Clinical Director of the Gastrointestinal Cancer Center and Director of the Program in Carcinoid and Neuroendocrine Tumors at Dana-Farber Cancer Institute. “I am pleased to present these important findings at ESMO today, as they underscore the potential of cabozantinib as a much-needed new treatment option for this disease, which is rising in incidence.”
In August, the Alliance Data and Safety Monitoring Board (DSMB) recommended the study stop and be unblinded early due to the dramatic improvement in efficacy observed at an interim analysis. The DSMB based their vote on data from interim analyses of PFS using local radiology assessments. Ancillary analyses were conducted using local and central assessments of patients enrolled through June 2023.
Results from the CABINET study presented today at ESMO demonstrate that treatment with cabozantinib resulted in compelling improvements in PFS based both on local review and on independent blinded central radiology review. At a median follow-up of 13.9 months, the median PFS for patients with epNET who took cabozantinib was 8.3 months, compared to 3.2 months for those who took a placebo. At a median follow-up of 16.7 months, patients with pNET who took cabozantinib had a median PFS of 11.4 months, compared to 3 months for those who took a placebo.
The safety profile of cabozantinib observed in each cohort was consistent with those found in other studies of the drug. These include hypertension, fatigue, diarrhea, and skin rash. No new safety signals were identified.
For patients with advanced NET, treatment options include somatostatin analogs (SSAs), targeted therapy, Lu-177 dotatate, which is a form of peptide-receptor radionuclide therapy (PRRT), or chemotherapy. More than half of patients in each cohort received prior everolimus or prior Lu-177 dotatate.
“The CABINET trial is a great example of the importance of the National Clinical Trials Network, sponsored by the National Cancer Institute, in conducting rigorous, practice changing trials at both academic and community oncology practices throughout the United States, working with industry partners, patient advocacy, and academia,” noted Eileen O’Reilly, MD, from Memorial Sloan Kettering Cancer Center and Jeffrey Meyerhardt, MD, MPH, from Dana-Farber Cancer Institute, who co-chair the Gastrointestinal Committee for the Alliance.
CABINET (randomized, double-blinded phase III study of CABozantinib versus placebo In patients with advanced NEuroendocrine Tumors after progression on prior therapy) is a multicenter, randomized, double-blinded, placebo-controlled phase III pivotal trial. As of June 2023, this trial enrolled 290 patients in two separate cohorts (pNET, n=93; epNET, n=197) in the United States and were included in the analyses reviewed by the Alliance DSMB. Patients were randomized 2:1 into the cabozantinib or placebo arms of the study in each of the two cohorts. Patients must have had measurable disease per RECIST 1.1 criteria and must have experienced disease progression after at least one FDA-approved line of prior therapy other than somatostatin analogs. The primary endpoint was PFS in each cohort. Upon confirmation of disease progression, patients were unblinded, and those receiving placebo were permitted to cross over to open-label therapy with cabozantinib. Secondary endpoints included overall survival, radiographic response rate and safety.
CABINET is sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and is being led and conducted by the NCI funded Alliance for Clinical Trials in Oncology with participation from the NCI funded national clinical trials network (NCTN) as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP). To learn more about the CABINET trials, visit ClinicalTrials.gov.
Follow the meeting live on X (formerly known as Twitter) using the hashtag #ESMO23 and follow the Alliance on X (formerly known as Twitter) at @ALLIANCE_org.
# # #
Reference: Alliance A021602: Randomized, double-blinded phase III study of cabozantinib versus placebo in patients with advanced neuroendocrine tumors after progression on prior therapy (CABINET). A full description of this clinical trial can be found at https://classic.clinicaltrials.gov/ct2/show/NCT03375320.
The Alliance for Clinical Trials in Oncology develops and conducts clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as research methods to alleviate side effects of cancer and cancer treatments. The Alliance is part of the National Clinical Trials Network (NCTN) funded by the National Cancer Institute (NCI) and serves as a research base for the NCI Community Research Oncology Program (NCORP). The Alliance comprises nearly 10,000 cancer specialists at hospitals, medical centers, and community clinics across the United States and Canada. To learn more, visit www.AllianceforClinicalTrialsinOncology.org.
END
MADRID ― Compared with pre-surgical (neoadjuvant) chemotherapy alone, adding perioperative immunotherapy – given before and after surgery – significantly improved event-free survival (EFS) in patients with resectable early-stage non-small cell lung cancer (NSCLC). Results from the Phase III CheckMate 77T study were presented today at the 2023 European Society for Medical Oncology (ESMO) Congress by researchers from The University of Texas MD Anderson Cancer Center.
At a median follow-up of 25.4 months, the median EFS with chemotherapy alone was 18.4 months, while the median had not yet been reached for patients receiving perioperative nivolumab, meaning EFS was prolonged ...
Boston – Belzutifan significantly reduced the risk of progression of clear cell renal cell carcinoma (ccRCC), the most common type of kidney cancer, in patients previously treated with immune checkpoint inhibitors and anti-angiogenic therapies compared with everolimus in a phase 3 clinical trial. The trial, led by Toni K. Choueiri, MD, Director of the Lank Center for Genitourinary Cancer at Dana-Farber Cancer Institute, showed the risk of progression was reduced by 25-26%.
The results were presented at the annual European Society for Medical Oncology (ESMO) Congress on October ...
The following Lancet papers will be presented at the European Society for Medical Oncology Congress 2023 (#ESMO 2023). The conference will take place between Friday 20th – Tuesday 24th October 2023.
Contact details for corresponding authors are provided should you wish to arrange an interview with the authors. Funding information is listed on the first page of each Article.
**Embargo: 13.00 [BST] / 14.00 [CEST] Friday 20th October 2023**
The Lancet: Pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma: interim analyses from the phase ...
A secondary analysis from the SWOG S0931 EVEREST trial has found that in the subgroup of patients with clear-cell renal cell carcinoma (RCC) who were at very-high risk of recurrence, those who were treated with everolimus after surgery had a statistically significant improvement in recurrence-free survival compared to patients getting placebo after surgery.
The results will be presented at the European Society of Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on Oct. 23, 2023 (poster 1887P) by Primo N. Lara, Jr., MD, lead author on the abstract. ...
Media contacts: Lisa Black, lblack@aap.org; or Adam Alexander, aalexander@aap.org
The parent’s universal cry in response to loud music-- “Turn that thing down!” -- is well-founded, as evidence shows that children and teens risk hearing loss by cranking up their personal listening devices. What families may not realize is that children are exposed to potentially harmful noise from infancy and that the effects are cumulative over a lifetime.
The American Academy of Pediatrics discusses the common sources and effects of noise, from infant sleep ...
Four senior bioengineering students at The University of Texas at Arlington have won the Biomedical Engineering Society (BMES) Coulter College for Healthcare Innovation competition for their work on an early detection device for atrial fibrillation.
Brady Killham, Juan Ramirez, Jeannette Santos and Michael Ikefuna, all seniors in UTA’s Bioengineering Department, earned the Best Overall award for their plan to develop FibGuard, a wearable, non-invasive atrial fibrillation early detection device.
UTA competed against teams from Vanderbilt, Purdue, Virginia Tech, Wake Forest, Texas A&M, the University of Oklahoma and Rensselaer Polytechnic ...
BIRMINGHAM, Ala. – Lung development in the fetus occurs at low oxygen tension in the womb, but after a very premature birth, the partly developed lungs of the tiny infants experience far greater oxygen tensions even without the prolonged supplemental oxygen that is often required. This can produce well-known disastrous effects on the structure and function of the neonatal lung, causing the serious lung condition of bronchopulmonary dysplasia in high-risk premature infants.
Using a neonatal mouse model, researchers ...
“The majority of wound infections often manifest themselves immediately postoperatively, so close followup should take place [...]”
BUFFALO, NY- October 20, 2023 – A new research perspective was published in Oncoscience (Volume 10) on October 4, 2023, entitled, “Diagnosis and management of postoperative wound infections in the head and neck region.”
In everyday clinical practice at a department for oral and maxillofacial surgery, a large number of surgical procedures in the head and neck region take place under both outpatient and inpatient conditions. The basis ...
The Brain & Behavior Research Foundation announced it is awarding $10.2 million in Young Investigator Grants to 150 promising early career scientists who are working to identify causes, improve treatments, and develop methods of prevention for psychiatric illnesses that impact millions of people in the United States and around the world.
The 2023 Young Investigators are focused on a broad range of psychiatric illnesses. More than half of the projects are relevant to the study or treatment of depression and schizophrenia. Addiction/substance-use disorders, anxiety, and ...
Cannabis use, even for medical purposes, could make some people sick due to harmful fungi that contaminate the plants.
That is the finding of a recently published peer-reviewed journal article, whose authors recommend further study and consideration of changes to regulations to protect consumers, especially those who are immunocompromised. They examined data, previous studies, and U.S. and international regulations related to the cannabis and hemp industry.
The article was published in Frontiers in Microbiology. It was researched and written by Kimberly Gwinn, professor of entomology and plant pathology at the University of Tennessee Institute ...
