The big news of the last 12 hours has been Amgen’s (AMGN) Denosumab (Deno). AMGN released top-line data last night showing that Deno had not only met its primary endpoint of reducing or delaying Skeletal Related Events (SRE) in breast cancer patients with bone mets, but was also better than Novartis’ (NVS) Zometa, currently the gold standard.

The news sent AMGN shares up almost 13% after-hours (currently up‎ $8.37‎ (16.03%‎) to $60.60 in pre-market trading)

AMGN also reported “infrequent” occurrences of osteonecrosis of the jaw for patients on either drug.

The data is clearly a positive for patients, AMGN and investors, the latter of which have been disappointed in recent months with the decrease in AMGN’s stock price.

On the flip side, there was no further mention of the potential safety issues that have surrounded Deno in recent months. Back in March, IguanaBio reported that Dr. Mike Lewiecki, an assistant professor of medicine at the University of New Mexico School of Medicine and an investigator on the Deno trial, warned that the FDA might request a black box because of the infection risk. He also mentioned a chance of the FDA asking for additional data.

Roger Perlmutter, head of Amgen’s R&D, said he did not expect the drug’s efficacy to be questioned, but noted that safety issues would come under scrutiny and that Deno patients had a higher rate of serious skin infections that required hospitalization.

The above statements, however, were over Deno’s post-menopausal osteoporosis indication, which comes under advisory panel on August 13th.

Here were Perlmutter’s comments on yesterday’s positive news:

“We are extremely pleased with the outcome of this important study, which shows that denosumab can reduce or delay the serious complications of bone metastases in breast cancer patients better than the current standard of care, and with a favorable benefit/risk profile.”

Overall, the news is extrememly positive and in a cancer setting, the benefits of delayed SRE’s here clearly outweigh any infection risk.

Stay tuned…

Anonymous Tip? Comments? Contact us: hr AT iguanabio DOT com

Related Posts