FDA Review of Lilly’s Experimental Cancer Treatment shows Clot Risk amid Encouraging Results

7/8/2015

The U.S. Food and Drug Administration (FDA) released the results of a 1093-patient study on Tuesday of drugmaker, Eli Lilly’s experimental drug necitumumab, aimed at treating a certain form of lung cancer. The information comes as the FDA will be conducting a panel of outside experts on Thursday, July 9^th that will review the study and decide whether or not to recommend the drug for approval. Although the FDA is not obligated to take the panel’s advice, it generally follows its recommendations. While the study produces evidence that the drug can be successful in extending life by over six weeks on average, there were significantly more occurrences of adverse events, and specifically regarding clotting. Although the potential dangers will be a major item of concern for the panel, the limited selection of lung cancer drugs on the market added to the measureable extension of life attributed to necitumumab, Eli Lilly is still optimistic it will receive a passing grade. If the drug does meet FDA approval, industry analysts estimate that the drug could generate $567 million in annual sales by 2020.

The clinical trial involved 1093 patients with advanced squamous non-small cell lung cancer, which is a subset of the most common form of lung cancer. Squamous lung cancer accounts for roughly 25 to 30 percent of all types of lung cancer. Necitumumab is intended to be taken with other chemotherapy drugs. In the clinical trial, patients who took the drug in combination with the medications, gemcitabine and cisplatin, lived an average of 11.5 months compared to a control group taking only the chemotherapy medications living an average of 9.9 months. 48 percent of patients in the necitumumab group experienced serious side-effects however; compared to 38 percent in the control group. This includes serious clotting among 9 percent of patients in the necitumumab group, as opposed to only 5 percent in the group only taking the chemotherapy drugs. 66 deaths occurred in the necitumumab group, with 15 of them declared drug-related, a 3 percent rate. The control group experienced 57 deaths, 10 of which were attributed to medications, a 2 percent rate. Eli Lilly also attempted but abandoned clinical trials for the drug on non-squamous lung cancer patients due to a high number of patients experiencing clotting. Before the study was closed, 11 percent of patients who used necitumumab experienced clotting compared to 6 percent in the control group, with no measurable differences in life expectancy.

Even though the risk/reward ratio of necitumumab may not compare well with most drugs seeking FDA approval, Eli Lilly executives and medical experts believe the drug merits approval. Fred Hirch, a researcher at the University of Colorado Cancer Center, and one of the principle investigators for the study concluded, “This is an improvement. Based on this large prospective study in first-line therapy of squamous lung cancer, a subtype of lung cancer where there is an urgent unmet need for treatment improvement, the drug warrants approval.” Lilly also has another drug on the market for small cell lung cancer, Cyramza, which was approved last year after demonstrating it could extend life by an average of six weeks. Company CEO John Lechleiter rebuffed critics who believe that the life-extending benefits are minimal, telling the Financial Times in February, “I get irked when some well-meaning commentator says two months (OS) isn’t much–they’re probably not dying of cancer.” Both Roche and Bristol-Myers Squibb currently have similar drugs on the market, Roche’s Avastin and Bristol’s Opdivo. The latter, recently approved for lung cancer treatment in March, demonstrated a 3.2-month additional survival rate in its clinical trials. The FDA will likely rule on the drug’s approval before the end of the year.

Sources:

Bloomberg Business – Anna Edney

Fierce Biotech – John Carroll

Reuters – Toni Clarke