The results of the retrospective analysis of data from the Phase III CRYSTAL trial in metastatic colorectal cancer (mCRC) were published in 2011. The new analysis examined the benefits of first-line treatment with Erbitux® in combination with standard chemotherapy (FOLFIRI) in KRAS wild-type patients, dependent on metastatic site. Results showed that in patients with advanced metastatic disease that had spread beyond the liver, the additional administration of Erbitux® compared to chemotherapy alone led to a significant increase in overall survival of more than five months in palliative treatment.
In 2011, a further analysis of the randomized Phase II OPUS trial demonstrated an association between early tumor shrinkage and long-term median overall survival of more than two years in metastatic colorectal cancer patients with KRAS wild-type tumors who were treated with Erbitux® in combination with the standard chemotherapy FOLFOX. These results confirm earlier outcomes of a similar analysis of the pivotal Phase III CRYSTAL trial.
In 2011, recruitment was completed into the pivotal Phase III EXPAND clinical trial investigating the efficacy of Erbitux® in patients with advanced gastric cancer. This international study has recruited more than 870 patients since commencing enrollment in 2008.
Since 2007, we have been studying the efficacy and safety of the cancer immunotherapy Stimuvax® in patients with inoperable stage III non-small cell lung cancer in the pivotal Phase III START trial. We completed patient recruitment in 2011.
Merck Serono entered into two collaboration agreements with Ono Pharmaceutical to strengthen its multiple sclerosis and cancer franchises. The oncology agreement provides Ono with rights to co-develop and co-market Stimuvax® in Japan.
We completed patient enrollment into the global pivotal Phase III clinical study CENTRIC in June. In this trial, we are assessing the safety and efficacy of cilengitide in glioblastoma, the most aggressive type of brain tumor. Cilengitide is the first integrin inhibitor in oncology to have entered Phase III clinical development.
In December 2010, we signed a worldwide research and development agreement with sanofi-aventis U.S. Inc. This collaboration provides mutual access to experimental compound combinations. The novel combinations include one of our MEK inhibitors as well as two early-stage development compounds from sanofi-aventis. The trials in solid tumors are in Phase I.
Overall, we are investigating five projects in Phase I trials in patients with solid tumors and hematological malignancies. A further four Phase II trials are underway in head and neck cancer, non-small cell lung cancer, colorectal cancer as well as prostate cancer.
In order to be able to forge ahead with the most promising projects, we intend to terminate or transfer to partners projects with risk-benefit profiles that do not meet our requirements. We therefore discontinued clinical development of Erbitux® in triple-negative breast cancer as well as of the immunomodulator IMO-2055. Clinical development of one of the two c-Met kinase inhibitors in Phase I was also terminated based on the available comparative data.
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