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Treatment with the anti–PD-1 therapy nivolumab plus the LAG-3–blocking antibody relatlimab extended time to disease progression for patients with previously untreated, unresectable, or metastatic melanoma. Findings from the RELATIVITY-047 trial were presented by Evan J. Lipson, MD, and colleagues...
Patients with resected early-stage non–small cell lung cancer (NSCLC) who received the PD-L1 inhibitor atezolizumab following cisplatin-based chemotherapy had a 34% reduction in the risk of disease recurrence compared with best supportive care, according to the results from the phase III IMpower010 ...
In a cohort of the phase II TROPHY-U-01 trial reported in the Journal of Clinical Oncology, Scott T. Tagawa, MD, MS, and colleagues found that the antibody-drug conjugate sacituzumab govitecan-hziy produced responses in patients with metastatic urothelial carcinoma progressing after platinum-based...
Formal discussant Stefania Scala, MD, of the Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, was impressed by the findings of KEYNOTE-629. “The second interim analysis for the locally advanced disease cohort and updated data for the recurrent/metastatic disease cohort of KEYNOTE-629 had ...
Single-agent pembrolizumab achieved durable responses and promising survival in patients with locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma, according to the second interim analysis of the phase II KEYNOTE-629 study, which was presented at the virtual American...
As reported in The Lancet Oncology by Caimi et al, the phase II LOTIS-2 trial has shown that the CD19-directed antibody–alkylating drug conjugate loncastuximab tesirine-lpyl produced durable responses in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study supported ...
In the phase II PATRICIA trial reported in the Journal of Clinical Oncology, Nancy U. Lin, MD, and colleagues found that pertuzumab plus high-dose trastuzumab produced central nervous system (CNS) objective responses and clinical benefit in 68% of patients with HER2-positive metastatic breast...
In the phase II DESTINY-CRC01 trial reported in The Lancet Oncology, Salvatore Siena, MD, and colleagues found that trastuzumab deruxtecan-nxki produced durable responses in patients with previously treated HER2-positive metastatic colorectal cancer. Study Details In the trial, 78 patients from...
Long-term cardiac safety and efficacy have been confirmed for the combination of pertuzumab plus trastuzumab in patients with early-stage HER2-positive breast cancer, according to the final analysis of the phase II BERENICE trial reported by Chau T. Dang, MD, and colleagues at the ESMO Breast...
In a phase II trial reported in the Journal of Clinical Oncology, Olson et al found that pembrolizumab plus low-dose ipilimumab produced durable responses in patients with advanced melanoma whose disease had progressed on immediate prior PD-1 or PD-L1 inhibitor therapy. Study Details In the U.S....
Except in patients with no smoking history, the addition of chemotherapy to immunotherapy does not add benefit as a first-line treatment in patients with stage IV nonsquamous non–small cell lung cancer (NSCLC) and high expression of PD-L1, according to real-world experience. Outcomes from the U.S. ...
Drug-related interstitial lung disease occurred in less than 16% of patients with HER2-positive metastatic breast cancer following treatment with trastuzumab deruxtecan-nxki (T-DXd) at the approved dose of 5.4 mg/kg. In addition, the majority of these cases were classified as grade 1 or 2,...
First results from the phase II GELATO study evaluating atezolizumab plus carboplatin presented at the ESMO Breast Cancer Virtual Congress 2021 demonstrated clinical benefit in patients with metastatic invasive lobular breast cancer, particularly in patients with triple-negative invasive lobular...
Discussant of this phase II study, Thomas Herzog, MD, Deputy Director of the University of Cincinnati Cancer Center and Professor of Obstetrics and Gynecology at the UC College of Medicine, called the results “very exciting.” “The 33% response rate with the combination of ixabepilone plus...
The addition of bevacizumab to ixabepilone could be a promising treatment strategy for a group of patients with cancer currently lacking therapeutic options, according to data presented during the virtual edition of the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women’s Cancer.1...
Long-term analysis of the Short-HER trial showed that 9 weeks of adjuvant trastuzumab conveyed benefits comparable to a 1-year course in patients with early HER2-positive breast cancer deemed to be at low or intermediate risk for disease recurrence. High-risk patients, however, derived considerably ...
Recently, the U.S. Food and Drug Administration (FDA) has granted Priority Review to the combination of pembrolizumab and lenvatinib for the treatment of both advanced renal cell carcinoma (RCC) and endometrial carcinoma. The FDA also granted Priority Review to ivosidenib for the treatment of...
It is incredible to reflect upon the scientific advances in the treatment of HER2-positive breast cancer over the past 23 years. Once considered the worst subtype of breast cancer, HER2-positive disease is now associated with the best long-term outcomes in this age of targeted treatments. With a...
As reported in JAMA Oncology by Hope S. Rugo, MD, of the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, and colleagues, the phase III SOPHIA trial has shown significantly prolonged progression-free survival with margetuximab-cmkb plus chemotherapy vs...
A significant survival advantage accrued to patients with stage IIB and IIC cutaneous melanoma who received adjuvant immunotherapy, a large retrospective cohort study reported at the Society of Surgical Oncology (SSO) 2021 International Conference on Surgical Cancer Care.1 The 3-year overall...
On February 22, 2021, cemiplimab-rwlc was approved for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC; locally advanced who are not candidates for surgical resection or definitive chemoradiation therapy or metastatic) whose tumors have high PD-L1 expression (tumor...
Formal discussant of CheckMate 915, Alexander Eggermont, MD, PhD, Chief Scientific Officer at the Princess Máxima Center for Pediatric Oncology, Utrecht, Netherlands, suggested that the lower doses of ipilimumab used in the current study may explain the lack of effect on relapse-free survival. The...
The addition of ipilimumab to nivolumab failed to improve outcomes compared with nivolumab alone as adjuvant therapy for resected melanoma, according to the results of the CheckMate 915 trial, presented at the virtual edition of the American Association for Cancer Research (AACR) Annual Meeting...
“There was never a night or a problem that could defeat sunrise or hope.” —Bernard Williams To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting...
Formal discussant of the CheckMate 816 trial, Jhanelle E. Gray, MD, of Moffitt Cancer Center, Tampa, said that both neoadjuvant and adjuvant therapies have been shown to improve overall survival and relapse-free survival in non–small cell lung cancer (NSCLC). “Overall, neoadjuvant outcomes compare...
Neoadjuvant chemotherapy with nivolumab plus platinum-doublet chemotherapy significantly improved pathologic complete response rates compared with chemotherapy alone in patients with resectable stage IB to IIIA non–small cell lung cancer (NSCLC), according to the results of the CheckMate 816 study...
As reported in the Journal of Clinical Oncology by Kathleen N. Moore, MD, and colleagues, the phase III IMagyn050/GOG 3015/ENGOT-OV39 trial has shown that the addition of atezolizumab to bevacizumab and chemotherapy did not significantly improve progression-free survival in patients with newly...
On May 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review designation to treatments for surgically resected, high-risk, muscle-invasive urothelial carcinoma and epidermal growth factor receptor exon 20 insertion mutation–positive metastatic non–small cell lung cancer (NSCLC)....
In a pilot study reported in the Journal of Clinical Oncology, Kumar et al found that the combination of brentuximab vedotin with AVD (doxorubicin, vinblastine, and dacarbazine) was highly active in patients with newly diagnosed, early-stage, unfavorable-risk Hodgkin lymphoma and may permit the...
A phase II trial has found found that BK virus (BKV)-specific T cells from healthy donors were safe and effective as an off-the-shelf therapy for BKV-associated hemorrhagic cystitis, a painful complication that is common after allogeneic stem cell transplants for patients with leukemia or lymphoma. ...
In a study reported in a research letter in JAMA Oncology, Sun et al found that first-line immune checkpoint inhibitor monotherapy was associated with better overall survival among patients with advanced non–small cell lung cancer (NSCLC) with PD-L1 expression ≥ 50% and KRAS variant vs KRAS...
More news has emerged from this week’s meeting of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC). The group voted 8 to 0 in favor of continuing the accelerated approval for pembrolizumab in sorafenib-pretreated patients with hepatocellular carcinoma; 6 to 2...
As reported by Martin Reck, MD, PhD, and colleagues in the Journal of Clinical Oncology, the 5-year follow-up of the pivotal phase III KEYNOTE-024 trial shows maintained overall survival benefit in patients treated with pembrolizumab vs chemotherapy—despite substantial crossover to the...
In an analysis from the Japanese RESPECT trial reported in the Journal of Clinical Oncology, Taira et al found that adjuvant trastuzumab monotherapy was associated with better health-related quality of life (QoL) vs trastuzumab plus standard chemotherapy for at least 12 months in women aged 70 to...
Roche has announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining the accelerated approval of atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for...
As reported in The New England Journal of Medicine by Aditya Bardia, MD, of the Division of Medical Oncology, Massachusetts General Hospital Cancer Center, and colleagues, the phase III ASCENT trial has shown prolonged progression-free and overall survival with the Trop-2–directed antibody-drug...
As reported in The Lancet Oncology by Andrew Bottomley, PhD, and colleagues, an analysis of the phase III EORTC 1325-MG/KEYNOTE-054 trial showed no clinically significant decline in health-related quality of life (HRQoL) with adjuvant pembrolizumab vs placebo in resected high-risk stage III...
Roche announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted seven to two in favor of maintaining accelerated approval of atezolizumab in combination with chemotherapy (nanoparticle albumin-bound paclitaxel, or nab-paclitaxel) for the treatment of ...
On April 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, ...
"The noblest pleasure is the joy of understanding.” —Leonardo da Vinci To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on novel...
On February 9, 2021, cemiplimab-rwlc was granted regular approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who were previously treated with a Hedgehog pathway inhibitor or for whom this type of therapy is not appropriate and granted accelerated approval for...
In a Perspective article in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCD), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie,...
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to bemarituzumab as first-line treatment for patients with fibroblast growth factor receptor 2b (FGFR2b)-overexpressing and HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma...
In a phase I trial reported in the Journal of Clinical Oncology, Hutchings et al found that the bivalent CD20-targeting T-cell–engaging bispecific antibody glofitamab produced high response rates and was associated with manageable toxicity in patients with predominantly refractory aggressive B-cell ...
On April 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior...
As reported in The Lancet Oncology by Alexander M.M. Eggermont, MD, and colleagues, the pivotal phase III EORTC 1325/KEYNOTE-054 trial has shown significant improvement in the secondary endpoint of distant metastasis–free survival—as well as continued benefit in the primary endpoint of...
In a phase II study (innovaTV 204/GOG-3023/ENGOT-cx6) reported in The Lancet Oncology, Robert L. Coleman, MD, and colleagues found that the tissue factor–directed antibody-drug conjugate tisotumab vedotin produced durable responses in previously treated patients with recurrent or metastatic...
Findings from the ASCO-designed phase II Targeted Agent and Profiling Utilization Registry (TAPUR) basket trial, reported in the Journal of Clinical Oncology by Alva et al, indicated that pembrolizumab showed activity in heavily pretreated patients with metastatic breast cancer and high mutational...