June 19, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Amgen , headquartered in Thousand Oaks, Calif., announced yesterday that its Phase III study of Vectibix (panitumumab) had met its primary endpoint in the treatment of chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC).
The study was designed to determine the survival benefit of Vectibix and best supportive care (BSC) in comparison to BSC alone in patient with mCRC. Overall survival (OS) was the endpoint. Secondary endpoints included progression-free survival (PFS). In the treatment arm receiving Vectibix, patients showed statistically significant improvement in OS.
“Amgen has been at the forefront of researching personalized approaches to treating cancer, and the Vectibix clinical program continues to underscore the importance of identifying options for patients based on their cancer’s genetic makeup,” said Sean Harper, executive vice president of research and development at Amgen in an statement.
“These positive overall survival results for Vectibix reinforce the importance of KRAS and RAS biomarkers in making treatment decisions in metastatic colorectal cancer.”
Vectibix was approved by the U.S. Food and Drug Administration (FDA) in 2006 for the standalone treatment of metastatic colorectal cancer. In 2014 it was approved along with the chemotherapy drug, Folfox, as a first-line therapy for a form of metastatic colorectal cancer.
This is more good news for Amgen, following last week’s unanimous recommendation for approval of Amgen’s Repatha (evolocumab) by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC).
Although that panel voted 15-0 recommending that Repatha be approved to treat homozygous familial hypercholesterolemia (HoFH), the committee expressed some reservations that although the drug appeared very effective at lowering the so-called bad cholesterol, LDL, it wanted more evidence that the drug would actually decreases incidents of heart attacks and strokes, which would typically require a larger outcomes clinical trial.
If finally approved later this summer, Repatha could be a billion-dollar drug in the hotly contested cholesterol market.
At the moment that market is dominated by statins, such as Pfizer Inc. ’s Lipitor and Merck & Co. ’s Zocor. Amgen’s Repatha and a similar product by Regeneron Pharmaceuticals, Inc. called Praluent, which is also expected to be approved later this summer, are a new type of drug that are injected rather than swallowed and use a different method of action than statins.
Amgen’s stock took a small bump at the news of the cancer trial success.
It was selling for $155.65 on June 18 and is currently selling for $161.34. It spiked on news of the FDA panel for Repatha on June 11 as well, selling for $154.80 on June 9 and jumping to $157.96 on June 11. For the last year it’s been mostly on the rise, having sold for $115.39 on July 17, 2014 and rising to a high of $170.17 on Dec. 19, 2014.
These approvals are particularly good news given that Amgen killed a major deal with AstraZeneca PLC in May over psoriasis drug brodalumab. During trials, a patient developed suicidal thoughts and behavior. This would require special restrictive labeling if it met final approval. Amgen pulled out of the deal, although there is some evidence AstraZeneca may continue the program.
After AstraZeneca CMO Abruptly Quits, Where Could He Be Headed?
This week the chief medical officer of British drugmaker AstraZeneca PLC abruptly quit his post to become the chief executive officer of an unnamed, smaller biotech company. That’s lead BioSpace to wonder, with his background in R&D and in large companies like Pfizer Inc. , where will Briggs Morrison wind up? We want to know your thoughts.
