Friday, July 11, 2014

ASCO 2014 kicks off with news on lenvatinib,....

The 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO) began on Friday in Chicago, providing a platform for the release of thousands of scientific abstracts and highly anticipated cancer research news. The meeting continues through Monday June 2, but here are some highlights from the earlier sessions.
Eisai’s lenvatinib shows promise in differentiated radioiodine-resistant thyroid cancer
Results from a recent study show that the drug lenvatinib could become a new, effective treatment option for patients with differentiated thyroid cancer that is resistant to standard radioiodine (RAI) therapy. Lenvatinib (E7080), produced by Japanese drug major Eisai (TYO: 4523) is a multi-kinase inhibitor being investigated for the treatment of various types of cancer.
In this study, 392 patients with differentiated thyroid cancer that was RAI resistant and had worsened within a year received either lenvatinib or an inactive treatment called a placebo. Patients receiving the placebo were offered treatment with lenvatinib if the cancer worsened.
About 65% of the patients receiving lenvatinib had the tumors shrink, usually within the first two months of treatment. Only 3% of patients receiving the placebo had the tumors shrink. In addition, researchers found that it took about 18 months for the disease to worsen for patients who received lenvatinib, compared with about four months for those who received the placebo.
The side effects of lenvatinib include high blood pressure, diarrhea, decreased appetite, decreased weight, and nausea. About 79% of patients needed to have their doses of lenvatinib reduced due to the side effects, although the lead author noted that these patients still benefitted from the lower doses.
“We are confident that, based on our findings, lenvatinib will eventually become a standard treatment for radioiodine-resistant thyroid cancer,” said lead study author Martin Schlumberger, a professor of oncology at the University Paris Sud in Paris, France. “As little as a year ago, this group of patients had no effective treatment options. It’s remarkable that today we now have two targeted therapies that could be potential options.” The targeted therapy sorafenib (Nexavar, from Bayer) is currently the only option outside of clinical trials available for patients with this type of thyroid cancer. It was approved by the US Food and Drug Administration in 2013 and by the European Commission last week. Lenvatinib is not currently approved by the FDA.


Results from a new study show that combining the targeted therapy ramucirumab (Cyramza) with standard chemotherapy lengthens the lives of patients with non-small cell lung cancer (NSCLC).
Cyramza is under development by US pharma major Eli Lilly (NYSE: LLY) and was approved in the USA for gastric cancer. Investment bank Cowen and Co forecast annual sales for the drug will reach $1.2 billion by 2020.
In this study, ramucirumab was combined with a current standard chemotherapy, docetaxel (Docefrez, Taxotere), as a second-line therapy, ie, after the first treatments, called first-line therapy, stop working. There are few treatments approved as second-line therapy for NSCLC, and those that are currently available do not often work very well, with patients living about seven to nine months.
The 1,253 patients who participated in this study had stage IV NSCLC that had worsened while receiving chemotherapy. They received either ramucirumab plus chemotherapy with docetaxel or an inactive treatment called a placebo plus docetaxel. Researchers found that almost 23% of patients who received ramucirumab plus docetaxel had the tumors shrink, compared with about 14% of those who received the placebo plus docetaxel. In addition, patients who received ramucirumab plus docetaxel lived about one and a half months longer than those who received the placebo plus docetaxel, ten and a half months compared with nine months.
“This is the first treatment in approximately a decade to improve the outcomes for patients in the second-line setting,” said lead study author Maurice Perol, head of Thoracic Oncology at Cancer Research Center of Lyon in France. “The survival improvement is significant because patients with advanced NSCLC typically have a very short survival time following second-line therapy,” he added,


In a recent study, researchers found that the combination of olaparib and cediranib (Recentin) - both from Anglo-Swedish drug major AstraZeneca (LSE: AZN) - kept recurrent ovarian cancer from worsening for almost nine months longer than treatment with olaparib alone. Recurrent ovarian cancer is cancer that has come back after the initial treatment.
The current standard treatment for recurrent ovarian cancer is chemotherapy, which can cause severe side effects and may not work very well because the cancer often develops a resistance to chemotherapy, meaning that the chemotherapy that was used initially can no longer control the cancer’s growth. This is why researchers have been studying other ways to treat recurrent ovarian cancer, such as the use of olaparib and cediranib.
“The significant activity that we saw with the combination suggests that this could potentially be an effective alternative to standard chemotherapy,” said lead study author Joyce Liu, an instructor in medical oncology at Dana-Farber Cancer Institute in Boston, USA, adding: “At the same time, this approach is not yet ready for clinical practice as neither of these drugs is currently FDA approved for ovarian or any other cancer. We also need additional clinical trials to confirm the findings of this study to see how this combination compares to standard treatment.”
In a Phase III ICON 6 trial, also presented at ASCO, cediranib demonstrated significant improvements in progression free survival and overall survival in platinum sensitive relapsed ovarian cancer, when given during and after chemotherapy, compared to chemotherapy alone.
AstraZeneca has consulted with regulatory agencies in the USA and European Union to understand how the results of the ICON 6 study conducted by the UK Medical Research Council (MRC) can best support a potential regulatory submission for approval of cediranib in ovarian cancer. As a result of these interactions, AstraZeneca is working with the MRC to conduct relevant analyses of cediranib data with a view to potential regulatory submissions later this year.
Eisai, Lenvatinib, Eli Lillly, Cyramza, Ramucirumab, AstraZeneca, Olaparib, Recentin, ASCO 2014

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