Merck is a leader in personalizing cancer care and remains committed to offering patients therapies tailored to their cancer. We are not only developing new, targeted therapies, but are also making an important contribution to the increasingly important field of biomarker research. Findings in this area will help to further personalize therapies and predict the clinical response of patients to treatments – as is possible, for example, with our targeted oncology drug Erbitux® and the KRAS wild-type status of tumors in patients with metastatic colorectal cancer (mCRC). In this way, we want to enhance efficacy, patient benefit and health economic performance.
In September, the latest results of the CRYSTAL study showed how successful this approach is. They demonstrate that the addition of Erbitux® to the standard first-line chemotherapy regimen FOLFIRI significantly improved overall survival in metastatic colorectal cancer patients with KRAS wild-type tumors. In patients with KRAS wild-type tumors who received Erbitux® in addition to FOLFIRI, median overall survival was extended by 3.5 months compared to patients receiving chemotherapy alone. This was the first time an overall survival benefit had been demonstrated with a targeted therapy in combination with FOLFIRI in this disease setting. The risk of disease progression was reduced by 30% while the likelihood of achieving a tumor response doubled overall to 57%.
Focusing on new indications for Erbitux®
Merck is supporting PETACC-8, an independent colorectal cancer trial that is being coordinated by the Fédération Francophone de Cancérologie Digestive (FFCD). This Phase III clinical trial is investigating the efficacy of Erbitux® plus standard chemotherapy in the adjuvant setting, meaning after complete surgical removal of the primary tumor, in patients with stage III colorectal cancer whose tumors were KRAS wild-type. The aim of the study is to determine whether the addition of Erbitux® to a standard chemotherapy regimen can lower the recurrence rate and prolong disease-free survival. The recruitment of 2,566 patients for the PETACC-8 study was completed in 2009.
In addition, Merck is investigating the efficacy of Erbitux® in gastric cancer in the pivotal Phase III EXPAND trial. This trial is investigating the benefit of Erbitux® in combination with standard chemotherapy in first-line treatment of patients with advanced and metastatic gastric cancer.
Cancer vaccine Stimuvax® being studied in breast and lung cancer
The therapeutic cancer vaccine Stimuvax® (liposomal vaccine BLP25) is currently being studied in two indications in three Phase III clinical trials. It is designed to induce an immune response to cancer cells that express MUC1 protein, an antigen that is over-expressed on the surface of tumor cells for example in advanced breast cancer and non-small-cell lung cancer (NSCLC) – the indications we are investigating.
We are currently conducting START, a Phase III trial to evaluate the efficacy and safety of treatment with Stimuvax® in patients with inoperable stage III non-small-cell lung cancer. The primary endpoint of the START trial, which began in 2007, is overall survival. The decision to initiate this trial was based on the results of a randomized Phase IIb study, in which Stimuvax® showed an increase in the survival time of a subset of patients with locoregional stage IIIb NSCLC from 13.3 months in the control group to 30.6 months in the treatment group. In December we initiated INSPIRE, a Phase III trial in NSCLC, in five Asian regions.
In addition, we started STRIDE, our first global Phase III clinical study of Stimuvax® in patients with advanced, inoperable breast cancer, in June 2009. The study will determine if Stimuvax® can extend progression-free survival in patients treated with hormonal therapy who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. Overall survival, quality of life, tumor response and safety will also be assessed in this study. STRIDE will enroll more than 900 patients with advanced breast cancer at an estimated 180 centers in over 30 countries – within North America, Europe, Asia and Australia.
Further oncology projects in the development pipeline
With the development of cilengitide, Merck is focusing on a new class of experimental cancer drugs. Cilengitide is the first integrin inihibitor to have entered Phase III clinical development (CENTRIC) in glioblastoma multiforme (GMB) – the most aggressive form of brain tumor. Integrin inhibitors are thought to work by targeting tumor cells and the vascular network required to nourish the tumor and promote cancer cell growth. Data from an independent and randomized Phase II study published in May show that in combination with chemoradiotherapy, cilengitide can extend survival in patients with newly diagnosed glioblastoma.
Apart from the GMB indication, we are investigating the efficacy of cilengitide in lung cancer as well as in head and neck tumors in two separate Phase II clinical trials.
In addition, we began studying the efficacy of the monoclonal anti-integrin antibody DI17E6 in colorectal cancer in a Phase II clinical trial in 2009. In December the immunomodulator IMO-2055 for the treatment of head and neck cancer entered Phase II clinical development.
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