In the phase III CEPHEUS trial,1 the achievement of undetectable measurable residual disease (or MRD negativity)—the primary endpoint—was met by 61% of patients with transplant-ineligible or deferred newly diagnosed multiple myeloma treated with the monoclonal antibody daratumumab plus bortezomib, ...
In an Italian phase III study (ARMANI) reported in The Lancet Oncology, Randon et al found that switch maintenance with ramucirumab/paclitaxel was associated with significantly improved progression-free survival vs continuation of first-line oxaliplatin-based chemotherapy in patients with advanced...
A recent report highlighted evidence-based recommendations for the prevention, detection, and management of cancer therapy–related cardiovascular toxicity and cardiovascular events in patients with cancer, as well as knowledge gaps. Select considerations are summarized herein. “The European Society ...
As reported in the Journal of Clinical Oncology by Russell et al, the NCRI AML18 trial has shown survival benefit with treatment intensification in fit older patients with measurable residual disease (MRD)-positive response after first induction for acute myeloid leukemia (AML). Study Details In...
As reported in The Lancet Oncology by Mell et al, the phase II/III NRG-HN004 trial of radiotherapy with durvalumab or cetuximab in patients with locoregionally advanced head and neck squamous cell carcinoma and contraindications for cisplatin was stopped for futility during phase II; the phase III...
The final overall survival analysis of the phase III PRIMA trial found no survival benefit for maintenance niraparib over placebo in advanced ovarian cancer. However, the PARP inhibitor continued to exert a sustained progression-free survival benefit, investigators reported at the European Society...
In a study reported in JAMA Network Open, Farris et al identified prognostic factors in patients with limited-stage small cell lung cancer (SCLC) receiving radiotherapy at two dose schedules in the CALGB 30610–RTOG 0538 trial. Study Details In the trial, 638 patients were randomly assigned between...
In a phase IIb trial (ReNeu) reported in the Journal of Clinical Oncology, Moertel et al found that the CNS-penetrant small molecule MEK1/2 inhibitor mirdametinib showed activity in adults and children with symptomatic neurofibromatosis type 1-associated plexiform neurofibroma (NF1-PN). Study...
As reported in The Lancet by Abramson et al, the phase III STARGLO trial has shown significantly improved overall survival with glofitamab plus gemcitabine/oxaliplatin vs rituximab plus gemcitabine/oxaliplatin in patients with transplant-ineligible relapsed or refractory diffuse large B-cell...
Both radiation and temozolomide may have meaningful single-modality antitumor activity against slow-growing, low-grade gliomas, according to recent findings presented by Schiff et al at the 2024 Society for Neuro-Oncology Annual Meeting (Abstract LTBK-07) and simultaneously published in...
In a retrospective study (OPBC-05/ICARO) reported in the Journal of Clinical Oncology, Giacomo Montagna, MD, MPH, of Memorial Sloan Kettering Cancer Center, New York, and colleagues found that nodal burden in patients with breast cancer with residual isolated tumor cells after neoadjuvant...
In a phase II trial reported in The Lancet Oncology, Vora et al found that short-course hypofractionated proton-beam therapy guided by 3,4-dihydroxy-6-[F-18]fluoro-L-phenylalanine (F-18–DOPA) positron-emission tomography (PET) and contrast-enhanced MRI produced good outcomes in patients aged ≥ 65...
This is Part 3 of First-Line Immunotherapy for Metastatic NSCLC: Special Populations and Unmet Needs, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Roy Herbst, Charu Aggarwal, and Karen Reckamp discuss the first-line...
In the final per-protocol analysis of the phase III KEYNOTE-811 trial, an overall survival benefit was shown by adding the PD-1 inhibitor pembrolizumab to trastuzumab and chemotherapy in treatment-naive, unresectable, HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.1...
Neoadjuvant therapy for patients with resectable stage III melanoma has recently emerged as a better approach than resection plus adjuvant therapy. At the European Society for Medical Oncology (ESMO) Congress 2024, updates of pivotal neoadjuvant studies demonstrated the long-standing benefit of...
Initial analysis from the PEACE-3 trial suggests that the addition of radium-223 dichloride to enzalutamide could offer a promising new first-line treatment option for patients with metastatic castration-resistant prostate cancer, according to data presented by lead study author, Silke Gillessen,...
Consolidation therapy with the PD-1 immune checkpoint inhibitor durvalumab is set to become the new global standard of care for patients with limited-stage small cell lung cancer (SCLC), according to groundbreaking data presented at the European Society for Medical Oncology (ESMO) Congress 2024.1...
An updated overall survival analysis of the phase III HIMALAYA study, now at 5 years, confirms the benefit for the STRIDE regimen of the monoclonal antibodies durvalumab plus tremelimumab in unresectable hepatocellular carcinoma.1 [The STRIDE regimen consists of a single priming dose of...
The combination of the VEGF tyrosine kinase inhibitor lenvatinib, the PD-1 inhibitor pembrolizumab, and transarterial chemoembolization (TACE) significantly improved progression-free survival in patients with intermediate-stage hepatocellular carcinoma (HCC) compared with TACE alone, according to...
Late-breaking findings from the phase IIIb/IV, open-label DESTINY-Breast12 trial support the use of the antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) in patients with HER2-positive metastatic breast cancer and brain metastases who have experienced disease progression on at least...
For women with early-stage triple-negative breast cancer, KEYNOTE-522 changed the treatment paradigm several years ago. Support for neoadjuvant use of the PD-1 inhibitor pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, was bolstered by the positive overall survival analysis...
A 3-week moderately hypofractionated radiotherapy regimen has been found to be noninferior to the 5-week fractionation when irradiating nodal areas in patients with breast cancer, according to data presented at the European Society for Medical Oncology (ESMO) Congress 2024.1 The 5-year results of...
In the neoadjuvant I-SPY2.2 trial, a treatment strategy including the antibody-drug conjugate datopotamab deruxtecan (Dato-DXd), partnered with the PD-L1 inhibitor durvalumab, yielded a high pathologic complete response rate, especially in immune-positive and ‘all-negative’ subtypes.1...
The European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona featured several groundbreaking trials with the potential to significantly influence clinical practice. These studies highlighted the benefits of new combination immunotherapy strategies and innovative approaches in the...
The studies summarized below were reported online over the past month in The ASCO Post, generating a high number of visitors. For comprehensive reviews of these studies and more, visit ASCOPost.com. Trastuzumab Duocarmazine in Previously Treated HER2-Positive Metastatic Breast Cancer In the phase...
My twin brother and I were adopted at 18 months old, so I don’t know the medical history of our biological parents and family. But for certain, cancer has played an integral—and heartbreaking—role in my life. Both of my adoptive parents were diagnosed with genitourinary cancers at relatively early ...
The multicenter phase III -CARMEN-LC03 trial did not meet its dual primary endpoints of progression-free and overall survival with the CEACAM5-directed antibody-drug conjugate tusamitamab ravtansine vs standard chemotherapy with docetaxel in previously treated patients with advanced nonsquamous...
The Association for Clinical Oncology (ASCO) submitted comments to the Office of the National Coordinator for Health Information Technology in response to the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed...
Hai-Qiang Mai, MD, of the Department of Nasopharyngeal Carcinoma at Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues reported their findings from a single-center phase II trial in The Lancet Oncology.1 They found that the addition of perioperative toripalimab to concurrent...
Based on results from the ongoing multicenter phase III CHIPOR trial, which were reported in The Lancet Oncology Jean-Marc Classe, MD, PhD, Head of the Oncological Surgery Department at the Institut de Cancérologie de l’Ouest, Saint Herblain, France, and colleagues, the addition of hyperthermic...
The p53-MDM2 inhibitor siremadlin given with the CDK4/6 inhibitor ribociclib showed activity in a subset of patients with well-differentiated/dedifferentiated liposarcomas enrolled in the biology-driven adaptive phase II MEGAMOST Ribociclib/HDM201 basket trial.1 MEGAMOST was designed to evaluate...
Firmonertinib (AST2818; formerly furmonertinib), a novel EGFR inhibitor, has shown activity and tolerability in patients with advanced non–small cell lung cancer (NSCLC) harboring EGFR P loop and aC-helix compressing (PACC) mutations, according to data presented at the International Association for ...
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to zanidatamab-hrii (Ziihera), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test. The FDA also approved ...
In a retrospective cohort study reported in The Lancet Oncology, Sean Miller, MD, of Veterans Affairs Ann Arbor Healthcare System, and colleagues found that immune checkpoint inhibitor treatment for cancer had similar efficacy and reduced toxicity in Black patients vs White patients in the U.S....
Georgina V. Long, PhD, MBBS, FRACP, of Melanoma Institute Australia and Royal North Shore and Mater Hospitals, The University of Sydney, and colleagues shared their findings from a pooled analysis of long-term outcomes in advanced melanoma reported in the Journal of Clinical Oncology.1 They found...
OCE Insights is developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Lieutenant Commander Mitchell Chan, PharmD, BCPS, Team Lead and Clinical Analyst, Lieutenant Cameron Wilson, PharmD, BCPS, BCCCP, ...
Question: Based on NATALEE and monarchE data, is there still a need for neoadjuvant chemotherapy in hormone receptor (HR)-positive, HER2-negative early breast cancer? Answer: In monarchE trial, the CDK4/6 inhibitor abemaciclib combined with endocrine therapy demonstrated long-term efficacy in...
“While clinical trials emphasize improvement in cure rates for patients with advanced classical Hodgkin lymphoma, an important goal is reducing the potential long-term effects of treatment,” commented Iris Isufi, MD, of the Smilow Cancer Hospital and Yale Cancer Center, New Haven, Connecticut, and ...
Neoadjuvant chemotherapy with vs without the PD-1 inhibitor nivolumab conferred a higher pathologic complete response rate and long-term event-free survival benefit in Asian patients with resectable non–small cell lung cancer (NSCLC), according to the global phase III CheckMate 816 trial. At the...
In a meta-analysis reported in The Lancet Oncology, Mastrantoni et al identified first-line chemotherapy regimens associated with better outcomes in patients with unresectable advanced or metastatic pancreatic cancer. Study Details The Bayesian network analysis included 79 randomized controlled...
In a phase II trial (SU2C-SARC032) reported in The Lancet, Mowery et al found that the addition of perioperative pembrolizumab to preoperative radiation therapy and surgery improved disease-free survival in patients with stage III soft-tissue sarcoma of the extremity. Study Details In the...
In a phase II trial reported in the Journal of Clinical Oncology, Ahn et al found the combination of the PLK1 inhibitor onvansertib with FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab showed activity in the second-line treatment of KRAS-mutant metastatic colorectal cancer....
A phase II clinical trial investigating the safety and efficacy of a triple combination of radiation, chemotherapy, and immunotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma found that the therapy was effective in shrinking tumors, allowing for surgery, and ...
In a phase II trial (EV-202) reported in the Journal of Clinical Oncology, Swiecicki et al found that the antibody-drug conjugate enfortumab vedotin showed activity in heavily pretreated patients with recurrent or metastatic head and neck cancer (HNC). Study Details In the study, 46 patients who...
In a phase II/III trial reported in JAMA Oncology, Sarkaria et al found that the addition of veliparib to temozolomide did not improve overall survival in patients with newly diagnosed glioblastoma with MGMT promoter hypermethylation. Study Details In the double-blind Alliance for Clinical Trials...
In addition to our in-depth analysis of important clinical trials presented at the European Society for Medical Oncology (ESMO) Congress 2024, there is always room for more coverage from The ASCO Post, including these brief summaries of other presentations of interest. They focus on a potential...
“Cancer in young adults is more complicated in part [because of the risk of] infertility and premature menopause,” commented Ann H. Partridge, MD, MPH, FASCO, Interim Chair, Department of Medical Oncology; the Eric P. Winer, MD Chair in Breast Cancer Research, Dana-Farber Cancer Institute; and ...
In a phase I study reported in The Lancet Oncology, Maruyama et al found that valemetostat—a novel dual inhibitor of EZH2 and EZH1—showed activity in patients with relapsed or refractory non-Hodgkin lymphoma. Study Details In the study, 90 patients from sites in Japan and the United States were...
Researchers have found that combining the immunotherapy drug pembrolizumab with standard chemotherapy may improve treatment outcomes in patients with small cell bladder cancer and small cell/neuroendocrine prostate cancer, according to a recent study published by Gu et al in Cell Reports Medicine....
Beyond the physical toll of the disease and its treatments, cancer often presents a host of legal and social issues that can significantly worsen a patient’s well-being and treatment outcomes. This column explains how medical-legal partnerships can offer a powerful tool to address these challenges ...