(Corrects spelling of name in eighth paragraph of story published Aug. 13.)
An experimental lung cancer drug from Eli Lilly & Co. (LLY:US) increased survival among patients with advanced disease compared with those on chemotherapy alone, a study showed. The shares gained 2.6 percent.
The drug, called necitumumab, met the primary endpoint of increasing survival in a trial involving 1,093 patients with non-small cell lung cancer whose disease had spread, the Indianapolis-based drugmaker said today in a statement. Necitumumab was tested in patients with a type of tumor known as squamous cell carcinoma.
If cleared for sale, 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.
“Squamous cell is an unmet medical need and there haven’t been many new therapies in quite some time,” Roy Herbst, the chief of medical oncology at the Yale Cancer Center in New Haven, Connecticut, said in a telephone interview. “The fact that this is a positive trial can only be a good thing. What we don’t know is how positive it is, and what the toxicity profile is.”
It’s also good news for Lilly, as investors weren’t anticipating a positive result. “This is a clear upside surprise,” Mark Schoenebaum, an analyst with ISI Group LLC, said today in a note to clients.
Lilly rose $1.40 to $54.96 at 4 p.m. New York time. The shares have gained 28 percent (LLY:US) in the past 12 months.
Next year, Lilly plans to release full results from the study at a scientific meeting and anticipates submitting the drug 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.
“Up until a couple years ago, we had no sense that squamous cell lung cancer had anything targetable,” Paul Paik, a doctor at Memorial Sloan-Kettering Cancer Center in New York, said in a telephone interview. “This trial is timely, in terms of figuring out if there’s anything else we can add to chemotherapy to make it better.” Paik was an investigator on the trial for Lilly.
If approved, the drug would be the first biologic therapy to treat patients with squamous lung cancer, Richard Gaynor, vice president, product development and medical affairs for Lilly Oncology, said in the statement.
Yale’s Herbst compared the drug with Erbitux, which is made by Lilly and sold by Bristol-Myers Squibb Co. in the U.S. Erbitux was derived partly from mouse antibodies, and could occasionally produce allergic reactions. Lilly’s new drug is fully human, he said, meaning the potential for side-effects could be lower.
Analysts had “basically zero” expectations for necitumumab, Schoenebaum said today 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 in this note.
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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