“Eli Lilly and Company (LLY) announced that data from several trials of CYRAMZA® (ramucirumab) will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, including a Phase II study of non-small cell lung cancer (NSCLC) patients in Japan. Other data, including those from global Phase III studies of CYRAMZA in gastric, non-small cell lung, and hepatocellular cancers, will also be presented at the meeting.
” ‘In just over a year, CYRAMZA received four full FDA approvals in advanced or metastatic forms of three of the world’s most common and deadly cancers – gastric, non-small cell lung, and colorectal. We believe this is a first for an oncology product, and our CYRAMZA ASCO disclosures supplement these clinical advances,’ said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. ‘Further data at the meeting show how we are investigating CYRAMZA in other difficult-to-treat cancers, such as hepatocellular carcinoma, to help address additional unmet needs for people battling this devastating disease.’ “
“AstraZeneca and Eli Lilly and Company (Lilly) today announced that they have entered into a clinical trial collaboration to evaluate the safety and preliminary efficacy of AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with ramucirumab (CYRAMZA®), Lilly’s VEGF Receptor 2 antiangiogenic cancer medicine. The planned study will assess the combination as a treatment for patients with advanced solid tumours.
“The Phase I study is expected to establish the safety and a recommended dosing regimen, with the potential to open expansion cohorts in various tumours of interest, for the combination of MEDI4736 and ramucirumab. Under the terms of the agreement, the trial will be sponsored by Lilly. Additional details of the collaboration, including tumour types to be studied and financial terms, were not disclosed.”
“Eli Lilly charges more than $13,000 a month for Cyramza, the newest drug to treat stomach cancer. The latest medicine for lung cancer, Novartis’s Zykadia, costs almost $14,000 a month. Amgen’s Blincyto, for leukemia, will cost $64,000 a month.
“Why? Drug manufacturers blame high prices on the complexity of biology, government regulations and shareholder expectations for high profit margins. In other words, they say, they are hamstrung. But there’s a simpler explanation.
“Companies are taking advantage of a mix of laws that force insurers to include essentially all expensive drugs in their policies, and a philosophy that demands that every new health care product be available to everyone, no matter how little it helps or how much it costs. Anything else and we’re talking death panels.
The gist: Cyramza, a drug recently approved for treating certain lung cancer patients, does not improve a standard treatment for stage IV non-small cell lung cancer (NSCLC). In a clinical trial, Cyramza was given to patients along with the drug pemetrexed (Alimta) and platinum chemotherapy. Some patients received only Alimta and platinum chemotherapy. None of the patients had yet been treated with chemotherapy. The researchers found that there was no significant difference between the two groups in terms of the amount of time that passed without their cancers worsening.
“In a study of patients with nonsquamous non–small cell lung cancer (NSCLC), the addition of ramucirumab (Cyramza) to pemetrexed (Alimta) and platinum chemotherapy did not significantly improve progression-free survival, according to a study by Doebele et al in Cancer. However, the investigators did suggest a possible clinical benefit of adding ramucirumab to established pemetrexed/platinum chemotherapy in patients with stage IV nonsquamous NSCLC not previously treated with chemotherapy.
“Studies have shown that patients with nonsquamous NSCLC who are treated with a combination of the platinum-containing agents pemetrexed and cisplatin have an overall survival of just 9 to 11 months. More recent studies in NSCLC have focused on the addition of targeted biologic agents, such as bevacizumab (Avastin), to platinum-containing chemotherapy to improve clinical outcomes. Bevacizumab, a humanized monoclonal antibody against the vascular endothelial growth factor ligand, is currently the only antiangiogenic agent approved for nonsquamous NSCLC. A correlation between VEGF receptor 2 (VEGFR2) expression and tumor microvessel density has been associated with a poor prognosis and lower relapse-free survival.
“With that in mind, Doebele and colleagues conducted a phase II study of the addition of ramucirumab to pemetrexed and platinum chemotherapy. Ramucirumab, a fully human immunoglobulin G1 monoclonal antibody, specifically binds to the extracellular domain of VEGFR2 with high affinity. The investigators wanted to determine whether the addition of ramucirumab to a standard first-line platinum-based combination chemotherapy regimen would result in prolonged progression-free survival….
“The results of this study indicate the addition of ramucirumab did not significantly prolong progression-free survival in patients with nonsquamous NSCLC. In addition, the overall response rate was not significantly improved for patients receiving ramucirumab vs those receiving only pemetrexed and platinum-based therapy. However, the investigators did suggest a possible clinical benefit of adding ramucirumab to established pemetrexed/platinum chemotherapy for the first-line treatment of nonsquamous NSCLC.”
The gist: A drug called Cyramza (aka ramucirumab) can now be taken by U.S. patients with metastatic, ALK-positive or EGFR-positive non-small cell lung cancer (NSCLC) that worsened after chemotherapy treatment. The drug is to be taken along with the chemotherapy drug docetaxel.
“The U.S. Food and Drug Administration today approved a new drug to treat non-small-cell lung cancer (NSCLC), offering patients new hope in fighting this difficult disease. Lung cancer is expected to lead to over 150,000 deaths in the United States this year alone, and NSCLC accounts for about 85 percent of all lung cancers.
“The drug, Cyramza (ramucirumab), was tested on more than 1,200 patients with NSCLC whose cancer worsened during or after first-line chemotherapy. The research was conducted as part of a multi-year, phase 3 clinical trial at UCLA and other centers in 26 countries on six continents. The study is the first in previously treated NSCLC patients to demonstrate a survival benefit in the entire study population in approximately a decade.
“Cyramza is an antibody that targets the extracellular domain of VEGFR-2, an important protein in the formation of vessels that supply blood to cancer cells. Patients were given the experimental drug in combination with docetaxel, a clinically approved therapy that is considered the cornerstone of second-line treatment in advanced NSCLC, said Dr. Edward Garon, the national principal investigator and a researcher at UCLA’s Jonsson Comprehensive Cancer Center.
“Results of the study were recently published by Dr. Garon and colleagues in The Lancet.”
The gist: A drug used to treat stomach cancer may also help treat people with advanced colorectal cancer. The drug, called Cyramza, was tested in a clinical trial—a research study with volunteer patients. The trial involved patients who had not been treated successfully with other approaches.
“Eli Lilly and Co’s LLY.N Cyramza stomach-cancer drug prolonged survival of patients with advanced colon cancer in a late-stage study, the U.S. drugmaker said on Friday.
“Based on favorable data from the Phase III study, Lilly said it would ask regulators in the first half of 2015 to approve Cyramza in patients with colorectal cancer that has spread to other parts of the body. It plans to present detailed results from the trial at a scientific meeting next year.
“The 1,000-patient global study, called RAISE, involved patients who had previously failed to adequately benefit from Roche Holding AG’s ROG.VX Avastin and other standard treatments.
“Patients taking Cyramza along with chemotherapy showed a statistical improvement in survival, compared with those in the study who took a placebo and chemotherapy.”
Editor’s note: This article covers the results of a clinical trial—a research study with volunteer patients. The goal of the trial was to test the effectiveness of adding a drug called ramucirumab (aka Cyramza) to treatment with the chemotherapy drug docetaxel. The patients who participated all had non-small cell lung cancer (NSCLC) that had worsened during platinum-based chemotherapy. The researchers found that ramucirumab provided patients with a small but significant improvement in survival time.
“In the phase III REVEL trial reported in The Lancet, Garon et al found that the addition of the antiangiogenic VEGFR-2 inhibitor ramucirumab (Cyramza) to docetaxel produced a statistically significant improvement in overall survival as second-line treatment in patients with stage IV non–small cell lung cancer (NSCLC) after progression on platinum-based therapy…
“In this double-blind trial, 1,253 patients with squamous or nonsquamous stage IV NSCLC from academic medical centers and community clinics in 26 countries on six continents were randomly assigned between December 2010 and January 2013 to receive docetaxel at 75 mg/m² and either ramucirumab at 10 mg/kg (n = 628) or placebo (n = 625) on day 1 of 21-day cycles until disease progression, unacceptable toxicity, withdrawal, or death. Patients had to have progressed during or after a single platinum-based chemotherapy regimen, with or without bevacizumab (Avastin) or maintenance therapy.
“Randomization was stratified by sex, region, performance status, and previous maintenance therapy. The primary endpoint was overall survival in the intent-to-treat population.”
“Researchers with UCLA’s Jonsson Comprehensive Cancer Centerreport that two new experimental drugs have shown great promise in the treatment of patients with non–small-cell lung cancer, which accounts for about 85 percent of all lung cancers. Lung cancer is the leading cause of cancer death in the United States.
“The drugs—ramucirumab and CO-1868—were shown in separate clinical trials to increase survival times with fewer toxic side effects than standard treatments. The findings were presented this week at the American Society of Clinical Oncology annual meeting in Chicago.”
Editor’s note: For more on the ramucirumab findings, see our previous news post. To learn more about targeted therapies like CO-1686 and ramucirumab, visit our lung cancer Basics.
“Cyramza™ (ramucirumab, IMC-1121B; Eli Lilly) is a human IgG1 monoclonal antibody directed against the extracellular domain of VEGFR-2. It was recently approved by the Food and Drug Administration (FDA) for advanced gastric cancer or gastroesophageal junction adenocarcinoma. On February 19, 2014, Lilly announced via press release that the REVEL trial was positive for both overall survival (OS) and progression-free survival (PFS) benefit. Results from the randomized, double-blind, placebo-controlled Phase III REVEL trial (NCT01168973) were reported at the 2014 annual meeting of the American Society of Clinical Oncology (ASCO). The trial evaluated docetaxel with or without Cyramza in squamous or non-squamous Stage IV non-small cell lung cancer (NSCLC) patients following disease progression after one prior platinum-based therapy.”
Editor’s note: A new targeted drug called Cyramza (aka ramucirumab) shows promise as a potential treatment for people with advanced non-small cell lung cancer (NSCLC). In a clinical trial, scientists tested the drug on volunteer patients with stage IV NSCLC. Compared to standard chemotherapy alone, patients who were treated with chemo plus Cyramza lived longer and had more time pass before their cancer worsened.
Update 6/9/14: According to Dr. Jack West of GRACE, the benefit of Cyramza is very minimal in the above-mentioned clinical trial, and is therefore not so promising.