http://www.bloomberg.com/apps/news?pid=20601087&sid=aYskrh56aY10&refer=home

Bayer, Onyx Stop Nexavar Test on Lung-Cancer Patients (Update3)

By Eva von Schaper and Angela Cullen

Feb. 18 (Bloomberg) -- Bayer AG, Germany's biggest drugmaker, and Onyx
Pharmaceuticals Inc. stopped a study of the Nexavar cancer drug against
lung tumors because the product failed to help patients live longer than
standard treatment.

Analysis of the test, dubbed ESCAPE, found a higher mortality rate in
patients with the squamous cell form of lung cancer who were taking
standard chemotherapy coupled with Nexavar then in those taking just
standard chemotherapy alone, the companies said. ESCAPE looked at more
than 900 patients with non- small cell lung cancer.

Bayer and Emeryville, California-based Onyx are reviewing the findings to
determine what effect ESCAPE may have on other lung-cancer trials.

Nexavar is targeted to block proteins on tumor cells to stop them from
proliferating and to cut off the blood supply to tumors, while leaving
healthy tissue unaffected.

The companies won approval from the Food and Drug Administration in
November as a liver-cancer treatment. Nexavar kept liver-cancer patients
alive almost three months longer than those on a placebo.
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Nexavar and liver cancer -  study involved 602 people
<
http://www.cancer.org/docroot/NWS/content/NWS_1_1x_Nexavar_Improves_Survival_in_
Advanced_Liver_Cancer.asp

People on Nexavar lived nearly 11 months, while those on placebo lived
about 8 months. It also took significantly longer for the liver tumors to
begin growing again in the patients on Nexavar: 5.5 months compared to 2.8
months for those on placebo.

Overall, side effects were similar in the two groups. People taking
Nexavar had more cases of diarrhea and skin reactions on the hands and
feet.
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http://www.fda.gov/bbs/topics/NEWS/2007/NEW01748.html
November 19, 2007        FDA Approves Nexavar for Patients with
Inoperable Liver Cancer
This type of cancer can be difficult to remove completely using surgery.
If all of the cancer cannot be removed, the disease is usually fatal
within three to six months.
A total of 602 patients were studied. Each patient received Nexavar or a
placebo. Both groups were comparable with regard to age, gender, race, the
stage and other characteristics of their cancer, and the types of cancer
treatment they had received before entering the clinical trial.

The most common adverse reactions that have been observed in patients
taking Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are
fatigue, weight loss, rash or superficial skin shedding, hand or foot skin
reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty
percent or more of patients had experienced at least one of these
reactions. In patients with hepatocellular carcinoma, diarrhea was
reported in 55 percent of patients who received Nexavar. Inadequate blood
supply to the heart or heart attack were reported in 2.7 percent of
patients who received Nexavar, compared to 1.3 percent for patients who
received placebo. New high blood pressure was reported in 9 percent of
patients who received Nexavar, compared to 4 percent of patients who
received placebo.

Elevated serum lipase, an enzyme that measures liver function, occurred in
40 percent of patients who received Nexavar, compared to 37 percent of
patients who received placebo, and hypophosphatemia, or low blood levels
of phosphate, occurred in 35 percent of patients who received Nexavar,
compared to 11 percent of patients who received placebo.