Merck PETACC-8 Study of Erbitux as Adjuvant Treatment in Colon Cancer Shows no Benefit

11-May-2012 - Germany

Merck announced results from an interim analysis of the Phase III clinical trial PETACC-81. The study investigated the potential clinical utility of Erbitux® (cetuximab) for the adjuvant treatment of stage III colon cancer after complete surgical removal of the primary tumor. The pre-specified interim analysis of the study did not support benefit in disease free survival for patients given Erbitux plus standard chemotherapy (FOLFOX 4) compared with patients treated with FOLFOX 4 alone. Therefore this interim analysis does not support the use of Erbitux for the adjuvant treatment of stage III colon cancer in this setting. PETACC-8 is a randomized, controlled, multinational European trial sponsored and coordinated by the Fédération Francophone de Cancérologie Digestive (FFCD), Dijon, France.

“We are disappointed not to see an improvement in disease free survival after 3.3 years of median follow up” said Professor Julien Taïeb from the Hôpital Européen Georges Pompidou, Paris, and the PETACC-8 Principal Investigator. “Unfortunately, since the introduction of FOLFOX as standard treatment, all attempts to further improve prevention of disease recurrence have proved unsuccessful. We look forward to sharing our data at future scientific congresses.”

The PETACC-8 trial was conducted in 2,559 European patients, including 1,602 whose tumors were KRAS wild-type, all with stage III colon cancer that had been fully resected (surgically removed). Patients were given either Erbitux plus FOLFOX 4 for six months or FOLFOX 4 alone. The pre-specified analysis was conducted when all patients had been followed up for a median of 3.3 years. In the adjuvant setting, the overall clinical goal is to destroy any cancer cells that may remain after the tumor has been surgically removed.

“While these results are disappointing, we continue to invest in expanding the science behind Erbitux to ensure its appropriate and safe use for patients living with cancer,” said Dr. Annalisa Jenkins, Head of Global Drug Development and Medical for the Merck Serono division.

Erbitux is indicated for the treatment of patients with KRAS wild-type metastatic colorectal cancer, and these results do not alter the current utility of Erbitux in its approved indications in metastatic colorectal cancer.

https://www.bionity.com/en/news/137861/merck-petacc-8-study-of-erbitux-as-adjuvant-treatment-in-colon-cancer-shows-no-benefit.html