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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...
Landmark changes in the treatment of genitourinary cancers have occurred over the past year, as summarized in this year’s Genitourinary Oncology Almanac from The ASCO Post. Starting with our area of focus, metastatic renal cell carcinoma, the saga continues with two more positive phase III trials...
Immune checkpoint inhibitors have transformed treatment for many advanced cancers, but short-term clinical trials and small observational studies have linked the medications with various side effects, most commonly involving the skin. A more comprehensive, population-level analysis now provides a...
Recently, the U.S. Food and Drug Administration (FDA) issued regulatory decisions related to treatments for urothelial cancer, cervical cancer, cholangiocarcinoma, solid tumors, and colorectal cancer. Acceptance of Two Supplemental Biologics License Applications for Enfortumab Vedotin-ejfv in...
As reported in The Lancet Oncology by Nancy Y. Lee, MD, and colleagues, the phase III JAVELIN Head and Neck 100 trial showed no improvement in progression-free survival with the addition of the PD-L1 inhibitor avelumab to chemoradiotherapy in patients with previously untreated locally advanced...
Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. CheckMate 649 The efficacy of the...
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia, University of Sydney, discusses results of the CheckMate 915 trial, which may reinforce nivolumab as an adjuvant standard of care in patients with stage IIIB–D/IV melanoma, with or without complete lymphadenectomy (Abstract CT004).
Michel Sadelain, MD, PhD, of Memorial Sloan Kettering Cancer Center, discusses the challenges in developing CAR T-cell therapy, as well as the progress being made, such as creating hybrid CAR and T-cell receptors that should enable T cells to recognize much lower levels of antigens. The field, he says, is poised to take on a range of solid tumors to extend the successes in hematologic malignancies.
In an analysis from the phase III KEYNOTE-177 trial reported in The Lancet Oncology, Thierry André, MD, and colleagues found that pembrolizumab was associated with clinically meaningful improvements in health-related quality of life (HRQOL) compared with chemotherapy in the first-line treatment of...
Charlotte E. Ariyan, MD, PhD, of Memorial Sloan Kettering Cancer Center, discusses improved outcomes with metastasectomy in the setting of checkpoint inhibitors, with the removal of residual disease and “escape” lesions. Surgical outcomes may also be better than targeted treatments, although long-term data and biomarkers are needed to confirm these findings.
In a study reported in the Journal of Clinical Oncology, Metzger et al found that the integration of brentuximab vedotin into front-line treatment of pediatric patients with high-risk classical Hodgkin lymphoma resulted in avoidance of radiotherapy in many patients, as well as high rates of...
In an Israeli case-control study reported in a commentary in The Lancet Oncology, Waissengrin et al found that the short-term safety of the Pfizer BNT162b2 mRNA COVID-19 vaccine was similar in patients with cancer receiving immune checkpoint inhibitors compared with healthy controls. Study Details...
Melinda L. Telli, MD, of Stanford Cancer Institute, discusses highlights of the new NCCN Clinical Practice Guidelines in Oncology®, including nonanthracycline, taxane-based regimens as preferred treatments for patients with HER2-positive breast cancer; newly approved combination therapies such as tucatinib plus capecitabine plus trastuzumab, margetuximab plus chemotherapy, and neratinib plus capecitabine; and recommendations for third line and beyond.
Richard S. Finn, MD, of UCLA Medical Center, discusses updated efficacy and safety data from the IMbrave150 trial of patients receiving atezolizumab plus bevacizumab vs sorafenib as first-line treatment for unresectable hepatocellular carcinoma (Abstract CT009).
Katelyn T. Byrne, PhD, of the Perelman School of Medicine at the University of Pennsylvania, discusses the first in-depth analysis of the impact of selicrelumab, an anti-CD40 antibody, which was found to enrich T cells in pancreatic tumors, activate the immune system, and alter the tumor stroma (Abstract CT005).
Carey K. Anders, MD, of the Duke Cancer Center, discusses the ways in which treatment of brain metastases arising from solid tumors has moved into a new era of patient care and how the field may advance.
In the Chinese phase III RATIONALE 307 trial reported in JAMA Oncology, Wang et al found that tislelizumab plus chemotherapy significantly prolonged progression-free survival vs chemotherapy alone in the first-line treatment of patients with advanced squamous non–small cell lung cancer (NSCLC). As...
As reported in The New England Journal of Medicine by Ronan J. Kelly, MBBCh, MBA, and colleagues, an interim analysis of the phase III CheckMate 577 trial has shown a significant improvement in disease-free survival with adjuvant nivolumab vs placebo in patients with resected esophageal or...