Regorafenib drug improves survival rates in patients with hepatocellular carcinoma

 In continuation of my update on Regorafenib

Oral multikinase inhibitor regorafenib achieves significantly improved survival rates compared to placebo in patients with hepatocellular carcinoma, according to data from the phase III RESORCE trial, presented at the ESMO 18th World Congress of Gastrointestinal Cancer in Barcelona, Spain.

"Systemic treatment for hepatocellular carcinoma has long consisted of just one agent - sorafenib -which was shown to provide a significant improvement in life expectancy almost 10 years ago, but no other agent has surpassed its benefits," said the study's principal investigator Dr Jordi Bruix, Head of the BCLC group at the Hospital Clínic and Scientific Director of the Network for Biomedical Research for Hepatic and Digestive Diseases (CIBEREHD).

While the last decade has seen many potential new agents for hepatocellular carcinoma fail in clinical trials, phase I and II data from early regorafenib trials were promising, and led to the initiation of this international, multi-center phase III trial.

Researchers enrolled 573 patients with intermediate or advanced stage hepatocellular carcinoma, who had all been previously treated with sorafenib, and randomized them 2:1 to 160mg oral regorafenib or placebo once daily for 1-3 of each four week cycle, in addition to best supportive care.

After a median of 3.6 months of treatment, patients on regorafenib showed a 38% reduction in the risk of death and a 54% reduction in the risk of progression or death compared to placebo.

Mean progression-free survival was 3.1 months with regorafenib and 1.5 months with placebo, while median overall survival was 10.6 months for regorafenib and 7.8 months with placebo.

Overall, 65.2% of patients on regorafenib showed complete or partial response or stable disease, compared to 36.1% of the placebo group.

Regorafenib had a similar safety and side effect profile to sorafenib, with hypertension, hand-foot skin reaction, fatigue and diarrhea all being significantly more common in patients taking the drug.

Dr Bruix said that the benefits of the drug were evident regardless of the cause or stage of the tumor, but analysis of biomarkers would reveal whether there might be certain sub-groups of patients likely to derive even greater benefit from this treatment.

"This is a very difficult to treat cancer but now we have an effective second-line agent, which is good news for the patients and also for the field as interest in further developments will be stimulated," Dr Bruix said.

Ref : http://www.esmo.org/Press-Office/Press-Releases/Regorafenib-Shows-Significant-Survival-Gains-in-Refractory-Liver-Cancer

New drug, regorafenib overcomes resistance in patients with rare sarcoma, study suggests

In continuation of my update on regorafenib

A new targeted drug demonstrated its ability to control metastatic gastrointestinal stromal tumor, an uncommon and life-threatening form of sarcoma, after the disease had become resistant to all existing therapies, report investigators at Dana-Farber Cancer Institute who led the worldwide clinical trial.

The oral drug regorafenib (see structure), which inhibits several cancer-promoting kinase enzymes, was able to control GIST for nearly four months longer than placebo in patients for whom Gleevec and Sutent were no longer effective, a result that was highly significant statistically.

"When added to best supportive care, regorafenib significantly improves disease control, as measured by progression-free survival time in patients with GIST after progression which represents failure of all other therapies," said George Demetri, MD, of Dana-Farber, principal investigator of this clinical trial.

Demonstrating the aggressive nature of this resistant disease, the study found that tumors objectively grew in less than a month, on average, in GIST patients who were initially randomized to receive a placebo. The study's "cross-over" design made it possible to treat those patients whose tumors grew, and 85 percent of the patients initially on placebo were able to receive regorafenib, which then controlled the disease in these patients as well.

Because of the study's cross-over design, Demetri said, it was not expected to prove that the patients initially randomized to receive regorafenib survived longer -- the researchers would have had to withhold the drug from the placebo patients to demonstrate that difference. "But there is no question that people are living longer" with regorafenib treatment, he said, based on the results of this trial.

An application to have regorafenib approved for use in resistant GIST is under an accelerated review by the Food and Drug Administration, Demetri said.

New drug overcomes resistance in patients with rare sarcoma, study suggests

Experimental Drug Might Help Some a Bit With Colon Cancer

In continuation of my update on regorafenib

 

The experimental cancer drug regorafenib appears to extend survival slightly in patients with metastatic colorectal cancer, a new trial indicates.

 

Regorafenib is a so-called multikinase inhibitor, which targets several of the ways cancer develops and grows, researchers said.

"The drug was tested on patients with metastatic colorectal cancer who had progressed after standard therapies, meaning they had no treatment options available," lead researcher Dr. Axel Grothey, a professor of oncology at the Mayo Clinic. 

The investigators found that patients taking regorafenib survived an average of 6.4 months, compared with five months for those receiving a placebo -- an increase in survival of 29 percent.

In addition, 44 percent of the patients taking regorafenib responded to the drug or had their cancer slowed, compared with 15 percent of the patients receiving placebo, they reported.

 

Ref : http://gicasym.org/GastrointestinalCancersSymposiumDailyNews/GI385.aspx

Phase III Trial of Regorafenib in Metastatic Colorectal Cancer Meets Primary Endpoint of Improving Overall Survival...

Bayer HealthCare Pharmaceuticals, announced the results from its Phase III trial evaluating its investigational compound regorafenib (see structure below, BAY 73-4506) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies: The trial met its primary endpoint of statistically significant improvement in overall survival. 

This is the result of a pre-planned interim analysis conducted by an independent Data Monitoring Committee (DMC) of the CORRECT (Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard t herapy) trial. Per the recommendation of the DMC, the study has been unblinded and patients in the placebo arm will be offered treatment with regorafenib. In this trial, the safety and tolerability of regorafenib were generally as expected.

"These data are significant because they demonstrate that regorafenib increased overall survival in patients with heavily pretreated metastatic colorectal cancer, an area of high unmet medical need," said Kemal Malik .....

Ref : http://www.bayer.com/en/news-detail.aspx?newsid=15124