Amgen (NASDAQ:AMGN) is looking at two great opportunities. The company's brightest immune-oncology prospect is giving mixed results on its own, but a valuable partnership seems likely. In the race to produce a next-generation cholesterol reducer, high marks from a difficult to treat population put Amgen in the pole position. Let's take a closer look at what look like the two biggest opportunities facing Amgen.
When it works... it really works
Most of the excitement surrounding cancer immunotherapies has shifted from vaccines to more promising immune checkpoint regulators. Amgen isn't in the anti-PD-1 checkpoint race, but it may have a chance to share in the success with talimogene laherparepvec, or T-vec.
This virus replicates inside infected tumor cells until they burst, while attracting an immune response. Recently presented data at this year's American Society of Clinical Oncology meeting suggests it could be an important part of combination therapies.
In a mid-stage trial, advanced melanoma patients were given a combination of T-Vec and Yervoy from Bristol-Myers Squibb. Tumors either shrank in size or were no longer detectable in more than half of patients when T-vec was given prior to and in combination with Yervoy. Given the tolerability of the combo and the advanced state of disease treated, eliciting a response from any patients would be impressive, but more than half is just incredible.
Not only does T-Vec help elicit responses from advanced patients, those responses are often durable. Amgen also presented data from a separate late-stage trial with T-vec as a monotherapy. When the advanced melanoma patients responded to T-Vec, the chances of that response lasting 12 months or longer was 65%.
Amgen's cancer virus/vaccine really needed the image boost. A failure to significantly improve overall survival in the monotherapy trial overshadowed the impressive response data. On its own, T-Vec treatment helped patients show a trend toward increased survival, but just below what would be considered statistically significant.
Amgen investors will want to keep an eye open for survival data from upcoming combination studies. Luckily, Bristol-Myers isn't the only company lining up to try its new cancer therapies alongside the novel virus. Earlier this year Merck (NYSE:MRK) agreed to test its anti-PD1 therapy pembrolizumab -- the antibody formerly known as MK-3475 -- with T-Vec in a phase 1-2 study with untreated advanced melanoma patients.
Last month the FDA accepted Merck's application for pembrolizumab to treat advanced melanoma. The company is expecting a response from the FDA in late October. If approved, it could help clear a path for a possible combination with T-Vec in the future.
Statin-less cholesterol control
Amgen's positives for the week didn't stop at oncology. The company scored another big win in the race to develop a next-generation low-density lipoprotein cholesterol, or LDL-C lowering drug. Evolocumab is an injectable antibody that inhibits PCSK9 -- a protein that regulates the liver's rate of LDL-C absorption.
Amgen is testing the new class of therapy in a wide range of patients, but the latest results come from perhaps the most difficult treatment profile. Homozygous familial hypercholesterolemia, or HoFH, is an extremely rare genetic condition marked by a lack of viable LDL-C receptors. Using evolocumab to slow reabsorption of the few receptors these patients do have, significantly reduced LDL-C.
The observed 31% LDL-C reduction from baseline could cause big trouble for Aegerion Pharmaceuticals (NASDAQ:AEGR). Its only marketed product Juxtapid is approved solely for the treatment of HoFH patients. While Juxtapid will likely remain necessary for most of the population, these results suggest Aegerion could lose in the years ahead. Amgen hasn't priced its PCSK9 therapy, but I think we can assume it will be far below Juxtapid's $300,000 per year. Given the extremely limited number of HoFH patients, every patient that opts for evoculamab over Juxtapid is going to sting.
On the cholesterol front, evolucumab's efficacy within an extremely difficult patient population is highly encouraging. The HoFH population is limited, but the results put Amgen another step ahead of competitors racing to develop a PCSK9 inhibitor.
Not long ago, Amgen's lack of late-stage anti-PD1 candidates was a concern for its overall oncology program. T-Vec's improved chance of becoming part of at least one anti-PD-1 combination therapy could give the company a much needed boost.