Featured Research

from universities, journals, and other organizations

Ipilimumab in advanced melanoma: Added benefit for non-pretreated patients not proven

Date:
March 18, 2014
Source:
Institute for Quality and Efficiency in Health Care
Summary:
In 2012, researchers determined a considerable added benefit for ipilimumab in pretreated patients. However, there were no suitable data for non-pretreated patients. Since the treatment effects presented by the manufacturer were not interpretable, an added benefit of ipilimumab in non-pretreated patients with advanced melanoma is not proven.

The German Institute for Quality and Efficiency in Health Care (IQWiG) already assessed the added benefit of ipilimumab in advanced melanoma in 2012. A considerable added benefit was found for patients who had already received previous treatment. In the new dossier compiled by the drug manufacturer, the drug was now compared with the appropriate comparator therapy dacarbazine specified by the Federal Joint Committee (G-BA) also for non-pretreated patients.

Again, the manufacturer claimed a noticeable gain in survival time and thus an added benefit. This time, IQWiG did not concur with the interpretation: The effect was estimated on the basis of an indirect comparison of individual patient data. The data were very uncertain and, moreover, by unilaterally excluding patients with particularly unfavourable prognosis, the effect was biased in favour of ipilimumab. Hence an added benefit of ipilimumab in advanced melanoma for non-pretreated patients is not proven.

Approval expanded

Ipilimumab is a monoclonal antibody used in melanoma if the disease is so advanced that the melanoma can no longer be surgically removed or has formed metastases. In 2012, the manufacturer presented informative data from a randomized controlled trial for pretreated patients. These data indicated a major advantage of ipilimumab in survival time, which was associated with major risk of harm, however.

After the European approval was expanded in 2013 to include patients who have not been treated for their advanced melanoma, the manufacturer now claimed an added benefit versus the appropriate comparator therapy dacarbazine specified by the G-BA also for this group.

Indirect comparison of low quality

However, the manufacturer neither presented a direct comparison nor a so-called adjusted indirect comparison between the study participants who received ipilimumab or the appropriate comparator therapy. Instead, it based its assessment on an indirect comparison of individual patient data from different studies on ipilimumab and on one single study on dacarbazine, from which it chose those patients who had not received previous treatment of advanced melanoma.

It can be assumed in these unadjusted indirect comparisons that patients on both sides of the comparison differ from each other with regards to important confounders, which can entail a systematic bias of the treatment effect. The manufacturer tried to account for these differences with a statistical method.

Results biased in favour of ipilimumab

However, the manufacturer only included those patients in its comparison for whom data on all confounders considered were available. Because of this, considerably more patients were excluded from the comparison on the ipilimumab side than on the dacarbazine side -- e.g. 40% compared to not even 1% in the outcome "overall survival." In the outcome "side effects," the numbers were even further apart. Many patients with particularly poor prognosis were apparently excluded from the analysis on the ipilimumab side. The effects were therefore highly biased in favour of ipilimumab.

Analysis did not consider all confounding variables

Furthermore, the manufacturer did not consider known confounders like the presence of visceral metastases, i.e. metastases in internal organs, or the time since the diagnosis of the melanoma in the analysis presented. The certainty of results, which was already low, was further downgraded because of this.

Since the treatment effects presented by the manufacturer were therefore not interpretable, an added benefit of ipilimumab in non-pretreated patients with advanced melanoma is not proven.


Story Source:

The above story is based on materials provided by Institute for Quality and Efficiency in Health Care. Note: Materials may be edited for content and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Ipilimumab in advanced melanoma: Added benefit for non-pretreated patients not proven." ScienceDaily. ScienceDaily, 18 March 2014. <www.sciencedaily.com/releases/2014/03/140318140801.htm>.
Institute for Quality and Efficiency in Health Care. (2014, March 18). Ipilimumab in advanced melanoma: Added benefit for non-pretreated patients not proven. ScienceDaily. Retrieved July 23, 2014 from www.sciencedaily.com/releases/2014/03/140318140801.htm
Institute for Quality and Efficiency in Health Care. "Ipilimumab in advanced melanoma: Added benefit for non-pretreated patients not proven." ScienceDaily. www.sciencedaily.com/releases/2014/03/140318140801.htm (accessed July 23, 2014).

Share This




More Health & Medicine News

Wednesday, July 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Courts Conflicted Over Healthcare Law

Courts Conflicted Over Healthcare Law

AP (July 22, 2014) Two federal appeals courts issued conflicting rulings Tuesday on the legality of the federally-run healthcare exchange that operates in 36 states. (July 22) Video provided by AP
Powered by NewsLook.com
Why Do People Believe We Only Use 10 Percent Of Our Brains?

Why Do People Believe We Only Use 10 Percent Of Our Brains?

Newsy (July 22, 2014) The new sci-fi thriller "Lucy" is making people question whether we really use all our brainpower. But, as scientists have insisted for years, we do. Video provided by Newsy
Powered by NewsLook.com
Scientists Find New Way To Make Human Platelets

Scientists Find New Way To Make Human Platelets

Newsy (July 22, 2014) Boston scientists have discovered a new way to create fully functioning human platelets using a bioreactor and human stem cells. Video provided by Newsy
Powered by NewsLook.com
Gilead's $1000-a-Pill Drug Could Cure Hep C in HIV-Positive People

Gilead's $1000-a-Pill Drug Could Cure Hep C in HIV-Positive People

TheStreet (July 21, 2014) New research shows Gilead Science's drug Sovaldi helps in curing hepatitis C in those who suffer from HIV. In a medical study, the combination of Gilead's Hep C drug with anti-viral drug Ribavirin cured 76% of HIV-positive patients suffering from the most common hepatitis C strain. Hepatitis C and related complications have been a top cause of death in HIV-positive patients. Typical medication used to treat the disease, including interferon proteins, tended to react badly with HIV drugs. However, Sovaldi's %1,000-a-pill price tag could limit the number of patients able to access the treatment. TheStreet's Keris Lahiff reports from New York. Video provided by TheStreet
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins