The MONET1 pivotal Phase 3 trial which evaluated motesanib administered together with paclitaxel and carboplatin to 1,090 patients with advanced non-squamous non-small cell lung cancer (NSCLC) did not meet its main goal of improving survival, a requirement for regulatory approval. Motesanib is made by Amgen Inc. and Takeda Pharmaceutical Co.

The majority of non-small cell lung cancers are of the non-squamous types. Non-small cell lung cancer is the most common form of lung cancer.

Amgen has been striving to come up with a novel treatment for cancer. Last year, denosumab was approved to delay bone fractures in patients with cancer. Among its three drugs in late-stage testing, Motesanib was the most promising, experts have said.

Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development, Amgen, said:

“We are disappointed with the results from this trial, but look forward to further analysis of the data which may ultimately help inform future research in this area.”

Nancy Simonian, M.D., chief medical officer, Millennium, said:

“We thank the patients, caregivers, and investigators for their participation and engagement in the clinical evaluation of motesanib worldwide. These disappointing results support the need for new treatments to address the unmet need in advanced non-squamous NSCLC.”

Motesanib blocks VEGF, a protein involved in the growth of blood vessels that supply tumors with the ingredients to survive.

In a communiqué, Amgen wrote “The trial did not meet its primary objective of demonstrating an improvement in overall survival (OS) (hazard ratio 0.90, 95 percent CI 0.78 – 1.04, p=0.14).”

According to the National Cancer Institute, USA, 157,000 Americans died of lung cancer in 2010. Approximately 223,000 new lung cancer diagnoses are made in the USA annually.

According to a joint statement by Amgen, Millennium and Taked, those on motesanib along with paclitaxel and carboplatin had a 10% smaller risk of dying during the study – the advantage “is not statistically significant”.

Written by Christian Nordqvist