TheStreet) -- The addition of
(LLY - Get Report) Cyramza to standard chemotherapy reduced the risk of death by 14% compared to standard chemotherapy alone in lung cancer patients no longer responding to initial, or first-line, therapy, according to phase III study results announced Saturday at the American Society of Clinical Oncology (ASCO) annual meeting.
With these results, doctors may start prescribing Cyramza to their lung cancer patients as a second-line therapy, although how Cyramza competes with already approved, second-line therapies such as Roche's (RHHBY) Tarceva or Lilly's own Alimta isn't entirely clear. Experimental cancer immunotherapies from Bristol-Myers Squibb (BMY) and Merck (MRK), among others, are also expected to soon have a role in treating lung cancer patients, based on early, promising clinical data.
Cyramza is a monoclonal antibody which blocks a protein known as VEGF responsible for the growth of new blood vessels to tumors. This is the same mechanism by which Roche's cancer drug Avastin works. Avastin is approved for first-line treatment of non-small cell lung cancer, although most patients enrolled in Lilly's Cyramza study weren't treated with it. The FDA approved in April Cyramza to treat gastric cancer. Lilly is expected to seek FDA approval to expand the drug's use into lung cancer.
In the phase III study, 1,253 patients with advanced lung cancer no longer responding to first-line chemotherapy were treated with Cyramza plus docetaxel or docetaxel and a placebo. Twenty-six percent of the patients enrolled had the squamous subtype of lung cancer, which is considered harder to treat.
The median overall survival in the Cyramza/docetaxel patients was 10.5 months compared to 9.1 months for patients in the study's control arm. The almost 1.5-month survival benefit for Cyramza was statistically significant and equated to a hazard ratio of 0.86, or a 14% reduction in the risk of death.
Median progression-free survival was 4.5 months for the Cyramza patients compared to 3 months for the control patients. Almost 23% of Cyramza patients reported a tumor response compared to 13.6% of patients in the control arm.
"This is the first treatment in approximately a decade to improve the outcome of patients in the second line setting," said Dr. Maurice Perol of France's Cancer Research Center of Lyon, in a statement. "The survival improvement is significant because patients with advanced non-small cell lung cancer typically have a very short survival time following second-line therapy."
Perol noted that the survival benefit favoring Cyramza was "consistent" in the major subgroups of patients enrolled in the study, including the squamous subtype. Roche's Avastin is also effective in squamous lung cancer patients but is not used because of an unacceptably high risk of bleeding.
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