By Bill Berkrot
(Reuters) - Eli Lilly and Co's cancer drug ramucirumab modestly extended survival in a large, late-stage study of patients with advanced, nonsmall cell lung cancer who had relapsed following initial treatment, according to data presented on Saturday.
In the 1,253-patient trial, those who received ramucirumab and the common chemotherapy drug docetaxel on average lived for 10.5 months compared with 9.1 months for those who got only the chemotherapy.
While the difference amounts to only about six weeks, it was deemed by researchers to be statistically significant and clinically meaningful due to the extremely poor survival prognosis for advanced lung cancer that comes back following initial treatment.
"This is the first treatment in approximately a decade to improve the outcome of patients" whose cancer has returned, Dr. Maurice Perol, the study's lead investigator and head of thoracic oncology at Cancer Research Center of Lyon in France, said in a statement.
Perol presented the data at the American Society of Clinical Oncology's annual meeting in Chicago.
Oncologists are looking for improved therapies known as second-line treatments for non-small cell lung cancer because virtually all patients eventually relapse.
Lung cancer is by far the leading cause of cancer death among men and women, according to the American Cancer Society. For 2014, it estimates there will be about 224,200 new cases of lung cancer and more than 159,200 deaths from the disease.
Ramucirumab, which won U.S. approval in April to treat advanced gastric cancer under the brand name Cyramza, is considered by Wall Street to be one of Lilly's most important new drugs. Investment bank Cowen and Co forecast annual sales for the medicine will reach $1.2 billion by 2020.
The biotech drug developed by Lilly's ImClone unit works by blocking the formation of blood vessels needed to feed tumor growth.
In addition to the survival data, the Lilly drug led to progression-free survival, the average time until the disease began to worsen, of 4.5 months versus three months for the control group. Tumor shrinkage was seen in 22.9 percent of the ramucirumab-plus-chemotherapy patients, compared with 13.6 percent for the chemotherapy-only group.
The survival benefit was consistent whether the patients had squamous or non-squamous forms of the disease, suggesting that the drug could be suitable for all major subtypes of nonsmall cell lung cancer, researchers said.
The drug's safety was consistent with medicines that work in a similar fashion, with no increase in the rate of lung bleeding, researchers said.
"Ramucirumab is an effective targeted agent when added to chemotherapy, with low toxicity," Dr. Gregory Masters, a lung cancer specialist, said in commenting on the research on behalf of the American Society of Clinical Oncology.
"This will be a significant benefit to those patients whose cancer progresses following initial chemotherapy," Masters, who is with Christiana Care Health System in Newark, Delaware, said in a statement.
(Editing by Jonathan Oatis)