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On January 19, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed...
Nivolumab (Opdivo) plus ipilimumab (Yervoy) led to a 1-year overall survival rate of 85% in previously treated metastatic colorectal cancer patients with DNA mismatch repair–deficient (dMMR) or microsatellite instability–high (MSI-H) tumors. These data were presented in the first report ...
Immune checkpoint inhibitors have had a dramatic impact on survival for patients with stage IV non–small cell lung cancer (NSCLC), with whispers that a cure might be achieved in a subset of patients. In typical fashion, active new agents are evaluated in earlier stages of disease. Stage III NSCLC...
On May 18, 2017, pembrolizumab (Keytruda) was granted regular approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...
Andrew X. Zhu, MD, PhD, of Massachusetts General Hospital, discusses study findings on pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (Abstract 209).
Thierry André, MD, of Hôpital Saint-Antoine, and Michael J. Overman, MD, of The University of Texas MD Anderson Cancer Center, discuss findings from their respective CheckMate-142 studies on nivolumab and ipilimumab in patients with DNA mismatch repair–deficient/microsatellite instability–high metastatic colorectal cancer (Abstracts 553, 554).
Florian Lordick, MD, of the University Medicine Leipzig, discusses study findings on intraperitoneal immunotherapy with the antibody catumaxomab for patients with peritoneal carcinomatosis from gastric cancer (Abstract 4).
Steven D. Leach, MD, of Dartmouth University’s Norris Cotton Cancer Center, discusses the personalized approach that GI cancers will require to make rational use of immunotherapy—including a subset of pancreatic cancers, which appear to be highly immunogenic and are associated with long-term survival.
Findings from the phase II KEYNOTE-224 trial investigating the use of pembrolizumab (Keytruda) in patients with advanced hepatocellular carcinoma who were previously treated with sorafenib (Nexavar) were presented by Zhu et al at the 2018 Gastrointestinal (GI) Cancers Symposium in San Francisco...
Venetoclax (Venclexta) plus rituximab (Rituxan)—a non–chemotherapy-containing regimen—was superior to standard-of-care bendamustine plus rituximab for patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to a final analysis of the phase III MURANO study reported at...
Primary analysis of the JULIET trial adds to mounting evidence that chimeric antigen receptor (CAR) T-cell therapy is effective for the treatment of lymphoma in patients with no other good treatment options. A single infusion of CAR T cells (CTL019) achieved durable remissions in almost 40% of...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 1, 2017, trastuzumab-dkst (Ogivri) was...
The combination of pembrolizumab (Keytruda) plus trastuzumab (Herceptin) may turn out to be a good treatment option for patients with trastuzumab-resistant advanced HER2-positive breast cancer, according to the results of an early study presented at the 2017 San Antonio Breast Cancer Symposium...
For more than a decade, breast cancer experts have wondered whether women with low levels of HER2 might derive some benefit from trastuzumab (Herceptin), based on signals seen in earlier trastuzumab trials. Most notably, in the landmark National Surgical Adjuvant Breast and Bowel Project (NSABP) ...
“The important thing is not to stop questioning. Curiosity has its own reason for existing.” —Albert Einstein The phase III international ECHELON-1 study, designed to evaluate brentuximab vedotin (Adcetris) as part of a front-line chemotherapy regimen for previously untreated advanced classic...
Today, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental Biologics License Application (sBLA) for tisagenlecleucel (Kymriah) suspension for intravenous infusion (formerly CTL019) for the treatment of adult patients with relapsed or refractory diffuse large...
The phase III KEYNOTE-189 trial—investigating pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and cisplatin or carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC)—met its dual primary endpoints of...
Desmoplastic melanoma is a rare subtype of melanoma that is commonly found on sun-exposed areas, such as the head and neck, and usually seen in older patients. Treatment is difficult, as these tumors are often resistant to chemotherapy and lack actionable mutations commonly found in other types of...
As reported in the Journal of Clinical Oncology by Robert and colleagues, a high proportion of patients with metastatic melanoma achieving complete response on pembrolizumab (Keytruda) in the phase Ib KEYNOTE-001 trial maintained complete response for prolonged durations after treatment...
On January 9, Eisai and Merck announced that they received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor lenvatinib (Lenvima) in combination with Merck's anti–programmed cell death protein 1...
On January 8, Merck and the European Organisation for Research and Treatment of Cancer (EORTC) announced that the phase III EORTC1325/KEYNOTE-054 trial investigating pembrolizumab (Keytruda) as monotherapy for surgically resected high-risk melanoma met its primary endpoint of recurrence-free...
The phase III IMvigor211 trial showed no survival benefit for atezolizumab (Tecentriq) vs physician's choice of chemotherapy in platinum-treated locally advanced or metastatic urothelial carcinoma with programmed death-ligand 1 (PD-L1) expression ≥ 5%. Findings were reported in The Lancet by...
On January 2, the U.S. Food and Drug Administration (FDA) accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The FDA also...
On December 21, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to avelumab (Bavencio) in combination with axitinib (Inlyta) for treatment-naive patients with advanced renal cell carcinoma. “A combination approach with an immunotherapy, whose activity may ...