© 2019 HSP News Service, L.L.C.
In a systematic review and meta-analysis reported in JAMA Oncology, Lu et al found that multiplex immunohistochemistry/immunofluorescence (mIHC/IF) assays appeared to have greater accuracy vs other types of assays in predicting response to anti–programmed cell death protein 1/programmed cell...
In the phase III ECOG-ACRIN 5508 trial, reported in the Journal of Clinical Oncology by Ramalingam et al, maintenance pemetrexed or bevacizumab was associated with no significant improvement in overall survival vs the bevacizumab control group alone, and was associated with greater toxicity in...
Huntsman Cancer Institute (HCI) at the University of Utah is the first Regence provider designated as a national Blue Distinction Center for Cellular Immunotherapy. Chimeric antigen receptor (CAR) T-cell therapy (CAR–T)-designated hospitals must be certified by a Risk Evaluation and Mitigation...
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a...
Microsatellite instability (MSI) is an important predictive biomarker of response to immune checkpoint blockade in solid cancers. However, despite recommendations by clinical practice guidelines, MSI is often not assessed, usually due to tissue insufficiency, unavailability, or infeasibility....
In an interim analysis of the phase III E1912 trial reported in The New England Journal of Medicine, Shanafelt et al found that ibrutinib/rituximab improved progression-free and overall survival vs standard chemoimmunotherapy in patients 70 years old or younger with previously untreated chronic...
In a phase I trial reported in the Journal of Clinical Oncology, Hont et al found that treatment of relapsed or refractory solid tumors with ex vivo expanded autologous multiantigen-associated specific cytotoxic T cells—or, tumor-associated antigen cytotoxic T cells—was safe and showed...
Immunotherapy as a treatment for advanced solid cancers has rapidly evolved over the past decade—often yielding remarkable results. However, its use has also given way to new adverse effects, including drug-induced gastrointestinal and liver toxicities. “Checkpoint inhibitors are a game changer...
This week, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to bempegaldesleukin in combination with nivolumab for advanced melanoma and cleared an investigational new drug application for a phase I trial of SB 11285 in advanced solid tumors. Breakthrough...
In a post hoc 5-year follow-up of the KEYNOTE-006 trial reported in The Lancet Oncology, Robert et al found that pembrolizumab maintained overall and progression-free survival benefits over ipilimumab in patients with advanced melanoma. In the primary analysis from the trial, both pembrolizumab...
In the first stage of a phase II trial reported in JAMA Oncology, O’Reilly et al found poor activity of durvalumab with or without tremelimumab in metastatic pancreatic ductal adenocarcinoma. Owing to the lack of efficacy, study expansion was not pursued. The lead-in open-label safety ...
In a phase II study reported in The Lancet Oncology, Adkins et al found that the combination of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib and the EGFR inhibitor cetuximab showed activity in patients with either platinum- or cetuximab-resistant human papillomavirus...
On July 30, the U.S. Food and Drug Administration (FDA) approved the programmed cell death protein 1 inhibitor pembrolizumab (Keytruda) as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed ...
As reported in the Journal of Clinical Oncology by Bachy et al, 9-year follow-up of the phase III PRIMA trial indicated a maintained progression-free survival benefit of maintenance rituximab vs observation following first-line induction therapy for follicular lymphoma. As in the prior reports from ...
As reported by Topalian et al in JAMA Oncology, long-term follow up of patients from a phase I expansion cohort study indicated 5-year overall survival rates of 34.2%, 27.7%, and 15.6% among patients who received nivolumab monotherapy for advanced melanoma, renal cell carcinoma (RCC), and...
Recently, the U.S. Food and Drug Administration (FDA) approved the inclusion of overall survival from the PACIFIC trial in the U.S. prescribing information for durvalumab and accepted applications for a new drug in the treatment of epithelioid sarcoma and two orphan drugs in the treatment of acute...
In a Dutch phase II study reported in JAMA Oncology, Theelen et al found that although use of stereotactic body radiotherapy prior to pembrolizumab increased the objective response rate vs pembrolizumab alone in metastatic non–small cell lung cancer (NSCLC), the difference did not meet study...
The 2019 ASCO Annual Meeting provided attendees with an abundance of clinically relevant abstracts in gastrointestinal cancers. Briefly featured here are clinical trial updates on pembrolizumab in the second-line treatment of hepatocellular carcinoma (KEYNOTE-240 trial), laparoscopic vs open...
ON JUNE 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-bvzr (Zirabev), a biosimilar to bevacizumab (Avastin), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung...
ON JUNE 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the anti– programmed cell death protein 1 (PD-1) therapy pembrolizumab (Keytruda) as monotherapy for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based...
At the 2019 ASCO Annual Meeting, two pivotal breast cancer trials reported final or additional analyses: one confirmed the negative results seen in earlier reports,1 and the other supported a new survival benchmark.2 KRISTINE: Neoadjuvant T-DM1/Pertuzumab Sara A. Hurvitz, MD, of the David Geffen...
Commenting for The ASCO Post, melanoma expert Vernon K. Sondak, MD, Chair of the Department of Cutaneous Oncology at Moffitt Cancer Center, Tampa, maintained that the association between immunotherapy-related toxicity and better outcomes is not yet clear. He first noted the impact of novel...
In the EORTC 1325/KEYNOTE-054 trial of adjuvant pembrolizumab in patients with stage III melanoma, recurrences were reduced by 44% in the immunotherapy arm, vs placebo, but this benefit increased to a 63% reduction in risk among patients developing an immune-related adverse event on treatment.1...
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the programmed cell death protein 1 inhibitor pembrolizumab in combination with the multiple kinase inhibitor lenvatinib for the potential first-line treatment of patients with advanced unresectable...
In a single-center phase II trial reported in JAMA Oncology, Bauml et al found that pembrolizumab given after locally ablative therapy appeared to be associated with improved outcomes in patients with oligometastatic non–small cell lung cancer (NSCLC). In the study, 45 evaluable...
In an Italian phase II trial reported in JAMA Oncology, Pietrantonio et al found that maintenance panitumumab alone was inferior in terms of progression-free survival (PFS) compared to maintenance panitumumab plus fluorouracil/leucovorin in RAS wild-type metastatic colorectal cancer. Study Details ...
Results from a phase IB trial expansion stage reported in The Lancet Oncology by Herbst et al showed the combination of ramucirumab plus pembrolizumab had manageable toxicity and antitumor activity in previously treated advanced gastroesophageal cancer, non–small cell lung cancer (NSCLC), and ...
In a study reported in the Journal of Oncology Practice, Van Tine et al found that infusion-related reactions occurred in 14.4% of patients receiving olaratumab in clinical trials, with grade ≥ 3 events occurring in 2.3%. (Olaratumab was withdrawn from the global market on April 25, 2019, based...
In a study reported in JAMA Oncology, Simonaggio et al found that rechallenge with an immune checkpoint inhibitor after occurrence of immune-related adverse events was associated with occurrence of an immune-related adverse event in approximately half of patients, with no increase in severity....
As reported in The Lancet Oncology, Hervé Tilly, MD, and colleagues found that the combination of polatuzumab vedotin, an antibody-drug conjugate targeting the CD79b component of the B-cell receptor, with immunochemotherapy showed high response rates in the phase II portion of a phase I/II study in ...
Despite an avalanche of novel therapies approved by the U.S. Food and Drug Administration (FDA) over the past decade in the treatment of multiple myeloma, including proteasome inhibitors and immunomodulatory drugs, this blood cancer remains largely incurable, and nearly 13,000 people are expected...
Many elderly and medically complex patients with metastatic renal cell carcinoma (RCC)—who are often underrepresented in clinical trials—saw overall survival benefits from treatment with targeted therapies, according to a study that analyzed 13 years of data on Medicare patients...
The final overall survival analysis of the phase III GOG-0218 trial, reported in the Journal of Clinical Oncology by Tewari et al, showed no benefit of adding bevacizumab to chemotherapy in women with newly diagnosed, incompletely resected, advanced ovarian cancer. The trial included 1,873 women...
Unlike non–small cell lung cancer (NSCLC), which has seen a paradigm shift in treatment modalities with the discovery of genetic signatures (including EGFR mutations) that are responsive to targeted drugs, systemic treatment of small cell lung cancer (SCLC) has remained largely unchanged for over...
In the phase III SOPHIA trial of 536 heavily pretreated patients with HER2-positive metastatic breast cancer, the novel anti-HER2 antibody margetuximab plus chemotherapy led to significant improvements in progression-free survival, response, and clinical benefit compared with...
A phase II study found that treatment with the antibody-drug conjugate enfortumab vedotin achieved responses in 44% of patients with locally advanced or metastatic urothelial cancer previously treated with platinum chemotherapy and a checkpoint inhibitor. This is a noteworthy study because it...
In a population of patients with metastatic colorectal cancer deemed to be at high risk by the presence of circulating tumor cells (CTCs), first-line treatment with FOLFOXIRI plus bevacizumab improved progression-free survival by about 3 months, compared with modified FOLFOX plus bevacizumab,...
In a pooled analysis of the phase I/II TOPACIO/KEYNOTE-162 study reported in JAMA Oncology, Konstantinopoulos et al found evidence of activity of combined niraparib and pembrolizumab in a cohort of patients with recurrent ovarian carcinoma. Study Details The analysis included 60 evaluable women...
Neoadjuvant immunotherapy had encouraging activity and demonstrated favorable safety in patients with resectable early-stage non–small cell lung cancer (NSCLC), according to two studies presented at the 2019 ASCO Annual Meeting.1,2 This approach has the potential to boost the survival rate in...
In a study reported in the Journal of Clinical Oncology, Phillips et al found that immune-related cutaneous adverse events in patients receiving immune checkpoint inhibitors generally responded to symptom- and phenotype-directed dermatologic therapies, and that biologic therapies were effective in...
As reported in The Lancet Oncology by Long et al, the phase III ECHO-301/KEYNOTE-252 trial showed no improvement in progression-free or overall survival with the addition of the IDO1 inhibitor epacadostat to pembrolizumab in unresectable stage III or stage IV melanoma. Study Details In the...
New research published in JNCCN—Journal of the National Comprehensive Cancer Network and presented by Jarushka Naidoo, MBBCh, at the NCCN 2019 Annual Conference suggests that institutions and networks that utilize immunotherapy should consider establishing multidisciplinary teams for...
Today, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received approval ...
Final analyses from the ALCANZA study, a phase III trial investigating brentuximab vedotin vs physician’s choice for the treatment of CD30-positive cutaneous T-cell lymphoma (CTCL), were presented by Horwitz et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract...
In a single-center study reported in the Journal of Clinical Oncology, Ricciuti et al found better outcomes with immune checkpoint inhibitor treatment among patients with advanced non–small cell lung cancer (NSCLC) receiving baseline prednisone equivalent of ≥ 10 mg daily for...
In the phase II TOPACIO/KEYNOTE-162 trial reported in JAMA Oncology, Vinayak et al found evidence of activity of combined niraparib and pembrolizumab in a cohort of patients with advanced or metastatic triple-negative breast cancer, with higher response rates seen in patients with BRCA mutations or ...
The MAVORIC study—presented by Scarisbrick et al at the 15th International Conference on Malignant Lymphoma (ICML; Abstract 034)—examined the efficacy of mogamulizumab, a monoclonal antibody that targets the CC chemokine receptor 4 (CCR4), in patients with previously treated mycosis...
In an analysis of the phase II GETUG-AFU 26 NIVOREN study reported in the Journal of Clinical Oncology, Flippot et al found that nivolumab had limited activity in patients with previously untreated brain metastases from clear cell renal cell carcinoma. The study assessed nivolumab in patients with ...
Recent technologic improvements in radiotherapy now offer an unprecedented opportunity to enhance immune response, and going forward, may play a role in the definitive treatment of head and neck cancer, according to William Stokes, MD, Assistant Professor in the Department of Radiation Oncology at...
Patients with human papillomavirus (HPV)-related head and neck cancer stand to benefit greatly from immunotherapy, according to Nabil F. Saba, MD, FACP, Director, Head and Neck Medical Oncology Program, Winship Cancer Institute of Emory University, Atlanta. He added, immunotherapy will likely play...