Lilly lung cancer drug raises patient survival in trial

Eli Lilly and Co.’s experimental lung cancer medicine increased survival among patients compared with those on chemotherapy alone.

Shares in the Indianapolis-based drugmaker rose as much as 5.5 percent Tuesday morning after the announcement.

The drug, called necitumumab, met the primary endpoint of increasing overall survival in a trial involving 1,093 patients with non-small cell lung cancer whose disease had spread, the company said in a statement. Necitumumab was tested in patients with a type of tumor known as squamous cell carcinoma.

If approved, the drug would be a potent boost to Lilly’s product portfolio. It would also mean a critical new therapy for a cancer that’s proven difficult to treat with drugs such as Avastin that directly target tumors, as opposed to more broadly active chemotherapy drugs.

“This is a clear upside surprise,” Mark Schoenebaum, an analyst with ISI Group LLC, said in a note to clients.

Next year, Lilly plans to release full results from the study at a scientific meeting and anticipates submitting it to regulatory authorities. Non-small cell lung cancer accounts for about 85 percent of lung cancer, and patients with squamous cell carcinoma make up about 30 percent of those patients. Lung cancer is the leading cause of cancer death in the U.S.

“If apprved, necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer,” Richard Gaynor, vice president, product development and medical affairs for Lilly Oncology, said in a prepared statement.

Lilly shares were up 4.4 percent, to $55.93 each at 10:46 a.m. The shares have gained 26 percent in the last 12 months as of Monday’s close.

Analysts had “basically zero” expectations for necitumumab, Schoenebaum said in his note. The drug failed in a prior non-squamous lung cancer trial, he said.

“We really need to see the full data to understand risk/benefit,” Schoenebaum said.

The most common adverse events seen in the study included rash. Less frequent, yet serious, side effects included blood clotting, Lilly said.

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WellPoint raises forecast after profit surges

Business continued to improve at WellPoint Inc. in the second quarter, helping the health insurer beat Wall Street’s expectations and raise its profit forecast for the year.

The Indianapolis-based company reported Wednesday morning that it earned $2.64 per share in the three months ended June 30. Excluding investment gains, WellPoint earned $2.60 per share, a 27.5-percent increase over the same quarter a year ago.

Analysts were expecting earnings of $2.11 per share, according to a survey by Thomson Financial.

WellPoint raised its full-year profit forecast by 20 cents per share, excluding the impact of investments, to $8 per share.

Overall profit for the quarter rose 24 percent from a year ago to $800.1 million, as WellPoint’s customers continued to file modest amounts of medical claims. WellPoint spent 83.9 percent of its premium revenue on claims, a tick higher than in the first quarter but well below its predicted level of 85.5 percent for the year.

“We are pleased with our second quarter results and encouraged by the positive momentum we have across the organization. Our commercial businesses continue to perform well and we have achieved improvements in our Medicaid operations,” WellPoint CEO Joe Swedish said in a prepared statement.

WellPoint’s revenue for the quarter rose 16 percent to $17.8 billion. Those numbers were boosted by WellPoint’s acquisition of Virginia-based Amerigroup Corp. in December.

Analysts were expecting revenue of $17.9 billion.

WellPoint provided health benefits for 35.7 million Americans at the end of June, more than any other company in the United States. WellPoint lost 143,000 members from its health plans in the second quarter, primarily because its employer customers trimmed their staffs.

WellPoint shares closed Tuesday at $87.51 apiece. They have soared in value since WellPoint named Swedish as its next CEO in February, rising nearly 33 percent.

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Restless legs syndrome: Study raises hope for better drugs

Editor's Choice
Main Category: Restless Legs Syndrome
Also Included In: Neurology / Neuroscience
Article Date: 30 Jul 2013 - 8:00 PDT Current ratings for:
Restless legs syndrome: Study raises hope for better drugs

John Hopkins researchers may have discovered why insomnia persists in patients with restless legs syndrome (RLS), despite successful treatment of the condition. 

People with restless legs syndrome, sometimes called "jimmy legs," have an uncontrollable urge to move their legs. The condition varies in severity and can be painful, distressing and interrupt daily activities as well as disturb sleep. 

In spite of effective drugs to relieve RLS, studies have shown that they do not improve sleep outcomes and only treat the restless legs. 

A research team led by Dr. Richard Allen, associate professor of neurology at John Hopkins University School of Medicine, has looked into solving the sleep anomaly, using MRI to image the brain in a group of 28 RLS patients and 20 non-RLS patients. 

Glutamate, the neurotransmitter involved in arousal, was found in abnormally high levels in the RLS group. The higher the level of glutamate recorded in the brain of those with RLS, the worse the patient's sleep. 

The research team recorded MRI images and glutamate activity in the thalamus - the part of the brain involved with the regulation of consciousness, sleep and alertness. 

RLS patients included in the study had severe symptoms: 

On six or seven nights a weekPersisting for at least six monthsWith an average of at least 20 involuntary movements a night.

The second stage of the experiment involved a two-day sleep study. RLS patients were reported to have received 5.5 hours sleep on average. The researchers identified a direct link in this group between glutamate levels in the thalamus and the number of hours of sleep. There was no such association in the non-RLS control group. 

Dr. Richard Allen is hopeful that the team may have discovered the reason why restless legs syndrome also affects sleep. He says:

"We may have solved the mystery of why getting rid of patients' urge to move their legs doesn't improve their sleep.

We may have been looking at the wrong thing all along, or we may find that both dopamine and glutamate pathways play a role in RLS."

The results of the study could lead to developments in the way RLS is treated, potentially helping to eradicate sleepless nights for people with restless legs syndrome. 

Dopamine-related drugs do work for many people with RLS, yet some lose benefit and require ever-higher doses. If the dose is too high, medication can aggravate symptoms to a state worse than that prior to treatment.

Dr. Richard Allen points out that despite drugs already being available that can reduce glutamate levels in the brain, such as the anticonvulsive drug gabapentin enacarbil (Horizant), they have not been given as a first-line treatment for RLS patients.

Dr. Allen adds that as more is understood about the neurobiology, his findings could apply to some forms of insomnia as well as restless legs syndrome.

Dr. Richard Allen says:

"It's exciting to see something totally new in the field - something that really makes sense for the biology of arousal and sleep."

Written by Sally Burr

See Sally's blog

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today Visit our restless legs syndrome section for the latest news on this subject.

Allen RP, Barker PB, Horská A and Earley CJ, Neurology, 2013 vol. 80 no. 22, pp2028-2034. Abstract/summary

The study was funded in part by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (R01 NS075184 and NS044862), the National Institute on Aging (P10-AG21190) and the National Center for Research Resources (M01RR02719).

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