Amgen melanoma drug fails to improve overall survival rates

Fri Apr 4, 2014 11:34am EDT

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(Reuters) - Amgen Inc said its experimental drug to treat a deadly form of skin cancer did not significantly improve overall survival rates in patients enrolled in a late-stage study.

The company said the drug met the study's main goal of shrinking tumors, as it had previously reported, but did not meet the secondary goal of improving overall survival in patients with melanoma.

The most common serious adverse events observed in the trial include disease progression, a bacterial skin infection and fever, the company said.

ISI Group analyst Mark Schoenebaum said the drug's failure to significantly improve survival rates could affect its chances for approval and limit its commercial opportunity as a single therapy.

Amgen said in June that data from the pivotal study showed that the drug improved survival by 21 percent for patients with advanced forms of melanoma compared with a standard white blood cell-boosting drug.

The company first reported in March last year that the drug,

talimogene laherparepvec, met the study's main goal of inducing a durable response rate (DRR) — defined as a complete or partial tumor shrinkage lasting at least six months — in 16 percent of patients.

Also known as T-Vec, the drug is injected directly into a tumor and is designed to replicate until the cancer cells rupture. It then activates the body's immune response to fight cancer cells that have spread to other areas.

Amgen is also testing the drug in combination with Bristol-Myers Squibb Co's melanoma drug Yervoy.

Skin cancer is the most common type of cancer in the United States, but melanoma, which begins in skin cells that make the pigment melanin, accounts for less than 2 percent of skin-cancer cases.

The American Cancer Society estimates that 76,100 new cases of melanoma will be diagnosed this year, and that the disease will kill about 9,710 patients.

The company's shares were little changed at $122.20 in morning trading on the Nasdaq on Friday. They closed at $124.13 on Thursday.

(Reporting by Vrinda Manocha in Bangalore; Editing by Simon Jennings)

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Comments (2)
BChinnian wrote:
This article is extremely misleading.

The test-group patients, who got Amgen’s experimental drug, indeed survived substantially longer than the control-group patients, who received an FDA approved drug. The hazard ratio was about 0.8.

The result was substantial but not statistically significant. The term “statistically significant” would apply if the p-value of the trial was .5 or below. Amgen’s trial had a p-value of .51, missing this arbitrary standard by only .001 . If the same average survival results had been obtained in a slightly larger number of patients (or if the patients had been split into groups 1:1 instead of 2:1), then the result would have been called “statistically significant” and heralded as a success.

When planning the trial Amgen needed to pick a large enough number of patients to determine whether the drug worked, but not so many that the trial took too long or was too expensive. It seems that Amgen picked almost the right number of patients to prove a survival advantage, but not quite enough.

That said, if a cancer patient in late-stage disease were to be presented the choice of Amgen T-vec or GM-CSF (the other drug in the trial) then he would clearly choose Amgen’s drug if his goal was to live longer.

Should another study be conducted to confirm this survival advantage? Yes. Was it a failure? No.

Apr 04, 2014 10:49pm EDT  --  Report as abuse
BChinnian wrote:
It should be remembered that Amgen’s press release of Nov 18, 2013 showed much better results for patients who were stage III and IV M1a (very sick patients comprising about 50% of the treatment group) as opposed to the other 50% (who were even sicker). Similarly, the drug performed better in comparison to the control drug in the subset of patients who hadn’t received prior therapy, with a hazard ratio of .49!

This difference was not surprising, since patients at an earlier stage have more time for T-vec to successfully attract the immune system’s attention to the cancer.

In particular, Amgen’s T-vec should be expected to perform even better in earlier-stage disease than were considered in this trial.

Apr 06, 2014 2:28am EDT  --  Report as abuse
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