The phase three clinical trials of another potential anti-cancer drug have been halted. Eli Lilly and Company (Lilly) and Bristol-Myers Squibb Company (BMS) announced today that they have stopped enrollment in one of their two global Phase III studies evaluating necitumumab. Phase III trials started early last year in lung cancer, and necitumumab already had a long way to go before BMS and Lilly we confident whether they are backing a winner.

The two companies share development costs and any potential commercialization within the U.S., Canada and Japan, while Lilly has exclusive commercialization rights in all other countries.

In a statement released by Lilly in February 2010, they addressed the complex business relationship:

“In January 2010, we restructured the collaboration agreement executed by ImClone and BMS in 2001 to allow for the co-development and co-commercialization of necitumumab, which is currently in Phase III clinical testing for non-small cell lung cancer. Within this restructured arrangement, we and BMS have agreed to share in the cost of developing and potentially commercializing necitumumab in the U.S., Canada, and Japan. We maintain exclusive rights to necitumumab in all other markets. We will fund 45 percent of the development costs for studies that will be used only in the U.S., and 72.5 percent for global studies. We will be responsible for the manufacturing of API and BMS will be responsible for manufacturing the finished product. We could receive a payment of $250.0 million upon approval in the U.S. In the U.S. and Canada, BMS will record sales and we will receive 45 percent of the profits for necitumumab, while we will provide 50 percent of the selling effort. In Japan, we and BMS will share costs and profits evenly.”

Necitumumab is a fully human IgG1 monoclonal antibody, and targets epithelial growth factor receptor, or EGFR. Theoretically this could mean it is safer than competitors, for example with fewer hypersensitivity side effects such as skin rash, and need dosing less frequently. The companies also hoped to prove it is better at fighting tumors.

The decision to stop enrollment followed an independent Data Monitoring Committee (DMC) recommendation that no new or recently enrolled patients continue treatment in the trial because of safety concerns related to blood clots in the experimental arm of the study, as the drug is injected. The DMC also noted that patients who have already received two or more cycles of necitumumab appear to have a lower ongoing risk for these safety concerns. These patients may choose to remain on the trial, after being informed of the additional potential risks.

If you were not aware, a Data Monitoring Committee is an independent body consisting of physicians and statisticians. Their responsibility is to review interim analysis data from clinical trials and make a decision on whether the trial is still set up correctly or needs modifications.

However, the DMC recommended necitumumab continues to be studied in a Phase III trial named SQUIRE. This study is evaluating necitumumab as a potential treatment for a different type of lung cancer called squamous non-small cell lung cancer in combination with GEMZAR® (gemcitabine HCl for injection) and cisplatin.

Richard Gaynor, M.D., vice president, oncology product development and medical affairs for Lilly states:

“Patient safety is paramount. While stopping enrollment in one of the two Phase III trials is disappointing, the SQUIRE Phase III study of necitumumab in lung cancer continues. Lilly remains committed to developing new medicines that can help treat this devastating disease.”

Source: Eli Lilly and Company

Written By Sy Kraft, B.A.