monoclonal antibody – Oral Cancer News

FDA grants priority review to first-line Toripalimab regimen in advanced nasopharyngeal carcinoma

Source: www.cancernetwork.com Author: Hayley Virgil A priority review was granted to toripalimab by the FDA for 2 indications in patients with advanced nasopharyngeal carcinoma. A biologics license application (BLA) for the combination of toripalimab (Tuoyi) plus gemcitabine and cisplatin for patients with advanced recurrent or metastatic nasopharyngeal carcinoma was accepted by the FDA and granted priority review, according to a press release from developer Junshi Biosciences.1 The BLA also covered the use of toripalimab monotherapy for the treatment of recurrent or metastatic disease following a platinum-containing regimen in the second line and beyond. The application for the anti–PD-1 monoclonal antibody is supported by findings from both the phase 2 POLARIS-02 trial (NCT02915432), which assessed toripalimab in previously treated and recurrent or metastatic nasopharyngeal carcinoma, and the phase 3 JUPITER-02 trial (NCT03581786), examining gemcitabine and cisplatin with or without toripalimab in recurrent of metastatic nasopharyngeal carcinoma.2,3 POLARIS-02 revealed durable clinical responses in those treated with toripalimab and JUPITER-02 identified notable improvements in progression-free survival (PFS). The Prescription Drug User Fee Act action date is currently set for April 2022. “We are excited by the continued progress of toripalimab toward a first marketing authorization outside of China,” Patricia Keegan, chief medical officer at Junshi Biosciences, said in a press release. “With the earlier approval in China, toripalimab became the world’s first immune checkpoint inhibitor for the treatment of nasopharyngeal carcinoma, bringing a novel therapy to a disease that has long lacked new drug development. We will cooperate closely with our partner, Coherus, [...]

Oral Cancer Foundation News Team - A2021-11-04T10:38:02-07:00November, 2021|Oral Cancer News|

Using proteogenomics to improve the treatment of squamous cell carcinoma

Source: blogs.bcm.edu, Baylor College of Medicine Author: Molly Chiu Patients with head and neck squamous cell carcinoma (HNSCC), the sixth most common epithelial cancer worldwide, are treated with surgery, chemotherapy and radiotherapy. In addition, targeted agents, including an EGFR monoclonal antibody (mAb) inhibitor and two programmed cell death protein 1 (PD-1) inhibitors, have been approved by the U.S. Food and Drug Administration for HNSCC treatment, but response rates are moderate. In this study, researchers led by Baylor College of Medicine, Johns Hopkins University and the National Cancer Institute’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) investigated what new insight proteogenomic analysis might offer into understanding why certain patients respond to certain treatments while other patients do not. They propose that their findings may help better match patients to an appropriate course of treatment in the future. Building a proteogenomic profile The team profiled proteins, phosphosites (a site on a protein associated with phosphorylation) and signaling pathways in 108 human papillomavirus-negative HNSCC tumors in order to understand how genetic aberrations drive tumor behavior and response to therapies. “We found three subtypes of head and neck squamous cell carcinoma, and each subtype may be a good candidate for a different type of therapy – EGFR inhibitors, CDK inhibitors or immunotherapy,” said Dr. Bing Zhang, lead contact of the study and professor in the Lester and Sue Smith Breast Center and the Department of Molecular and Human Genetics at Baylor. “We also identified candidate biomarkers that could be used to match patients to effective [...]

Oral Cancer Foundation News Team - A2021-02-04T21:09:30-07:00February, 2021|Oral Cancer News|

Pembrolizumab immunotherapy effective in recurrent, metastatic head and neck cancer

Source: www.cancertherapyadvisor.com Author: Debra Hughes, MS Pembrolizumab immunotherapy is effective for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), results of the KEYNOTE-012 trial presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting have shown. At a fixed dose of 200 mg intravenously every 3 weeks, pembrolizumab “was well tolerated and demonstrated a clinically meaningful overall response rate of 24.8% in patients with recurrent/metastatic SCCHN,” reported Tanguy Y. Seiwert, MD, an assistant professor of medicine, and associate HNC program leader at The University of Chicago in Chicago, IL. However, “it is important to note that response rate may underestimate the rate of benefit in patients, and ultimately we need to assess survival,” said Dr. Seiwert in an ASCO press release. “We know from other diseases where the experience with immunotherapy is larger, that patients who have disease stabilization or even initially experience disease progression upon receiving immunotherapy ultimately may derive significant benefit that can translate into longer survival.” Pembrolizumab (MK-3475), a humanized monoclonal antibody that blocks interaction of PD-1 with its ligands, PD-L1 and PD-L2, promotes activity of tumor-specific effector T cells. Previously, the KEYNOTE 012 study had demonstrated clinical activity of pembrolizumab 10 mg/kg every 2 weeks in patients with recurrent/metastatic SCCHN enriched for PD-L1–positive tumors. Response rate was 20%. Dr. Seiwert reported on the study's larger SCCHN expansion cohort, irrespective of PD-L1 expression or HPV status, using a 3-weekly fixed dose. The primary end point was overall response rate [...]

Oral Cancer Foundation News Team - A2015-06-03T06:53:18-07:00June, 2015|Oral Cancer News|

Docetaxel regimen tops cisplatin in head and neck cancer

Source: www.cancernetwork.com Author: Anna Azvolinsky, PhD A phase II study has demonstrated that combining docetaxel-based chemoradiotherapy and the antibody cetuximab postoperatively in patients with high-risk squamous cell carcinoma of the head and neck led to improved disease-free and overall survival, with no unexpected toxicities. The results of the study were published in the Journal of Clinical Oncology. Two-hundred and thirty-eight stage III and IV patients were randomized to receive radiation therapy (60 Gy) plus cetuximab and either cisplatin (30 mg/m2) or docetaxel (15 mg/m2) once per week as part of the Radiation Therapy Oncology Group (RTOG) 0234 clinical trial. The 2-year overall survival (OS) was 69% in the cisplatin treatment arm and 79% in the docetaxel treatment arm. The 2-year disease-free survival (DFS) was 57% and 66% in the cisplatin and docetaxel arms, respectively. Previously, two large phase III trials, the RTOG 9501 and the European Organisation for Research and Treatment of Cancer (EORTC) 22931 trials, both showed a small but significant survival benefit for postoperative head and neck cancer patients who received adjuvant radiation and chemotherapy concurrently, resulting in the incorporation of cisplatin in an adjuvant regimen for high-risk patients. The drawback was that adding cisplatin to radiation therapy increased toxicity. Many of these patients are not candidates for the combination therapy due to poor performance status, older age, and renal insufficiency. The purpose of the current trial was to test whether combining a molecular therapy such as cetuximab with chemotherapy would improve survival with a better toxicity profile, [...]

Oral Cancer Foundation News Team - A2014-07-19T07:13:12-07:00July, 2014|Oral Cancer News|

Experimental EGFR inhibitor added nothing but rash

Source: www.oncologypractice.com Author: Neil Osterweil, Oncology Report Digital Network The addition of the experimental targeted agent zalutumumab to primary curative chemoradiation for head and neck cancers did not improve locoregional control, disease-specific survival, or overall survival at 3 years of follow-up. The only thing that zalutumumab added to therapy was a skin rash in the large majority of patients who received it, reported Dr. Jens Overgaard, of the department of experimental clinical oncology at Aarhus University, Denmark. Response to zalutumumab, a monoclonal antibody targeted to the epidermal growth factor receptor (EGFR), was not related to tumor human papillomavirus 16 (HPV/p16) status or to chemoradiotherapy, Dr. Overgaard reported at the Multidisciplinary Head and Neck Cancer Symposium. The results of the DAHANCA 19 trial echo those of the RTOG (Radiation Oncology Therapy Group) trial 0522, which found no benefit from the addition of the EGFR inhibitor cetuximab (Erbitux) to accelerated cisplatin-based chemoradiotherapy, said Dr. Paul Harari, an invited discussant from the University of Wisconsin, Madison. "Where I think we have a lot of unanswered questions is acknowledging how little we actually understand about EGFR biology, despite now 40 years of progressive knowledge," Dr. Harari said. "We’re now seeing very clearly in molecular and clinical correlate studies that the more we suppress the EGFR, the more we see collateral overexpression of additional RTKs [receptor tyrosine kinases], including members of the HER family, such as HER-3, that enable an escape mechanism for tumors that become resistant to EGFR inhibition," he said. Dr. Overgaard and [...]

Oral Cancer Foundation News Team - A2014-03-19T07:20:46-07:00March, 2014|Oral Cancer News|

Researchers discover potential biomarkers to identify patients with head and neck cancer

Published on June 1, 2013 at 4:16 AMSource: news-medical.net Researchers from Fox Chase Cancer Center will present data at the 49th Annual Meeting of the American Society of Clinical Oncology on Saturday, June 1, which shows the discovery of potential biomarkers that may be used to identify patients with head and neck cancer whose tumors are unlikely to respond to treatment by the targeted therapy cetuximab-a type of monoclonal antibody. The FDA approved the drug, in combination with radiation or as a second-line drug after chemotherapy had failed, in 2006. In 2011, the drug was approved as a first-line treatment for metastatic disease, in combination with chemotherapy. "Targeted therapies should optimally be used in patients who are selected for sensitivity or the absence of sensitivity, and we've been handicapped by not knowing the resistance in head and neck cancers," says Barbara Burtness, MD, chief of head and neck medical oncology at Fox Chase and chair of the Eastern Cooperative Oncology Group (ECOG), a National Cancer Institute-funded team of researchers who organize and carry out clinical trials. Before cetuximab, head and neck cancer patients' only options were conventional platinum-based chemotherapy and radiation, says Burtness. But since tumors in different people may have different biologies, not all patients respond to same treatment in the same ways. Those whose tumors do not respond to cetuximab suffer the drug's side effects without gaining benefits. Biomarkers can help providers match appropriate treatments to disease. They may also provide inroads toward re-sensitizing tumors to treatment by [...]

Charlotte Parker2013-06-03T10:31:21-07:00June, 2013|Oral Cancer News|

Roche scientist provides a look at drugmaker’s early pipeline

Source: www.nj.com/ Author: Susan Todd/The Star-Ledger Jean-Jacques Garaud, who heads Roche’s pharmaceutical research and early development efforts in Switzerland, visited the drugmaker’s Nutley campus in mid-December and spent some time speaking with The Star-Ledger about the company’s efforts in the laboratory. The talk with Garaud provided a rare glimpse of the giant Swiss drugmaker’s early-stage pipeline and highlighted the heavy bets it’s making on personalized medicine (drugs that are tailored to treat individuals whose genes or enzymes show specific biological signs of disease). If the strategy succeeds, Roche could eventually push out some breakthrough drugs for cancer, Alzheimer’s disease and depression. Garaud, a French-American who joined Roche five years ago, also opened up about a discovery made in Nutley that may represent a novel cancer treatment and the high hopes behind a project with the promise of altering the lives of individuals born with a syndrome that causes mental retardation. During the interview, Garaud talked about some medicines so early in development that they are still referred to by strange-sounding laboratory names. Q. Where do things stand with gantenerumab, the monoclonal antibody Roche is developing as a treatment for Alzheimer’s disease? A. This is in phase 2 and this is testing a patient population in the early stages of the disease or suffering from mild cognitive impairment. We believe this particular type of intervention may be more beneficial when it happens early in the disease so that it delays progression. This antibody targets the abnormal material called amyloid that deposits [...]

Oral Cancer Foundation News Team - A2012-01-02T06:41:44-07:00January, 2012|Oral Cancer News|

US FDA approval for expanded use of Erbitux

Source: www.pharmabiz.com Author: staff The US Food and Drug Administration (FDA) has approved Erbitux (cetuximab), in combination with platinum-based chemotherapy with 5-fluorouracil (CT), for the first-line treatment of recurrent locoregional or metastatic squamous cell carcinoma of the head and neck (SCCHN). The approval, which is based on data from the landmark EXTREME (ErbituX in first-line Treatment of REcurrent or MEtastatic head & neck cancer) trial, makes Erbitux plus CT the first treatment regimen approved in 30 years with extended overall survival in patients with recurrent locoregional or metastatic SCCHN. Erbitux (cetuximab) is a monoclonal antibody (IgG1 Mab) designed to inhibit the function of a molecular structure expressed on the surface of normal and tumour cells called the epidermal growth factor receptor (EGFR, HER1, c-ErbB-1). In vitro assays and in vivo animal studies have shown that binding of ERBITU Erbitux GFR blocks phosphorylation and activation of receptor-associated kinases, resulting in induction of apoptosis (cell death), inhibition of cell growth, and decreased matrix metalloproteinase and vascular endothelial growth factor production. In vitro, Erbitux can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain human tumor types. In vitro assays and in vivo animal studies have shown that Erbitux inhibits the growth and survival of tumour cells that express the EGFR. No anti-tumour effects of Erbitux were observed in human tumour xenografts lacking EGFR expression. EXTREME, which was previously published in the New England Journal of Medicine, was a phase III open label, randomized, multi-centre, controlled trial. This study was conducted outside the US by [...]

Oral Cancer Foundation News Team - A2011-11-09T06:24:41-07:00November, 2011|Oral Cancer News|

ASCO: Non-platinum regimen works in head, neck cancer

Source: www.medpagetoday.com Author: Michael Smith, North American Correspondent, MedPage Today A novel non-platinum-based regimen was efficacious in recurrent or metastatic squamous cell head and neck cancer, researchers said. The combination of pemetrexed (Alimta) and bevacizumab (Avastin) yielded a response rate of 30% in a small single-arm trial, according to Athanassios Argiris, MD, of the University of Pittsburgh, and colleagues. The combination also increased the length of time before patients progressed, and increased median overall survival, Argiris and colleagues reported in a poster discussion session at the annual meeting of the American Society of Clinical Oncology here. Patients with recurrent or metastatic disease typically have a poor prognosis, the researchers said, with median survival between six and nine months with standard chemotherapy. But, in other research, adding the monoclonal antibody cetuximab (Erbitux) to platinum-based chemotherapy increased survival, they said. Bevacizumab is a monoclonal antibody that targets the vascular epithelial growth factor (VEGF), which is expressed in squamous cell head and neck cancer; high levels of VEGF correlate with poor outcome, they noted. The researchers hypothesized that the antibody might enhance the activity of pemetrexed, which is a multi-targeted antifolate indicated for malignant pleural mesothelioma and non-small cell lung cancer. To test the idea, they analyzed results of treating 37 patients given 500 mg/m2 of pemetrexed and 15 mg/kg of bevacizumab intravenously every 21 days until disease progression. Patients were also given folic acid and vitamin B12. The primary endpoint of the study was time to progression, they said, but the researchers [...]

Oral Cancer Foundation News Team - A2010-06-06T07:32:19-07:00June, 2010|Oral Cancer News|

ASCO: Antibody improves head and neck cancer results

Source: www.medpagetoday.com Author: Michael Smith, North American Correspondent, MedPage Today A novel antibody improved outcomes for patients with advanced and inoperable squamous cell carcinoma of the head and neck, researchers reported. Combined with radiation or chemoradiation, the substance -- a fully humanized monoclonal antibody dubbed nimotuzumab -- significantly outperformed either modality alone in an open-label randomized trial, according to K. Govind Babu, MD, of Kidwai Memorial Institute of Oncology in Bangalore, India, and colleagues. At the same time, there was little serious toxicity -- such as debilitating skin rash -- attributed to the compound, the researchers reported in a poster discussion session at the annual meeting of the American Society of Clinical Oncology here. It's the first randomized study of the drug to show clinical benefit without the toxicities associated with similar antibodies, the researchers said. In general, neither radiation nor chemotherapy provides a good outcome for patients with inoperable stage III or IVa squamous cell carcinoma of the head and neck. However, substances such as cetuximab (Erbitux) that target the epidermal growth factor receptor (EGFR) -- overexpressed in such tumors -- have improved outcomes. Nimotuzumab, like cetuximab, targets EGFR, but is highly selective for tumor tissues, limiting toxicity, the researchers said. The study enrolled 92 patients, and 76 were evaluable for efficacy. They were treated with radiation or chemoradiation (with cisplatin), with or without nimotuzumab. The substance was given by intravenous infusion of 200 milligrams over a 60-minute period, once a week for six weeks. In group A -- [...]

Oral Cancer Foundation News Team - A2010-06-06T07:24:13-07:00June, 2010|Oral Cancer News|