Please login to the form below

Not currently logged in
Email:
Password:

Trial backs Keytruda use first-line in lung cancer

Suggests Merck & Co’s drug is more effective than chemotherapy for NSCLC patients

Merck & CoMerck & Co's PD-1 inhibitor Keytruda is more effective than chemotherapy when used first-line in previously-untreated patients with non-small cell lung cancer (NSCLC), according to a new study.

The company - known as MSD outside the US - did not reveal details but said top-line results from the KEYNOTE-024 trial showed Keytruda (pembrolizumab) improved both progression-free survival and overall survival compared to platinum-based chemotherapy.

The data monitoring committee for the study had recommended it be stopped early after a clear benefit of Keytruda emerged, said Merck, allowing patients not on its drug to switch to the checkpoint inhibitor. It now plans to share the data with regulatory authorities in a bid to expand Keytruda's labelling in NSCLC.

Roger Perlmutter, president of Merck Research Laboratories, said the KEYNOTE-024 findings "have the potential to change the therapeutic paradigm in first-line treatment of NSCLC".

The positive results are a boost for Merck in its ongoing rivalry in the PD-1 inhibitor class with Bristol-Myers Squibb and its Opdivo (nivolumab) product, which is currently ahead in the market in terms of sales.

Both Keytruda and Opdivo are approved for second-line treatment after chemotherapy in NSCLC patients, but Merck is the first of the two companies to have first-line data in hand. BMS' first-line trial - called CheckMate-026 - is due to generate its first results in November.

The trial involved 305 patients whose tumours had a high proportion of PD-L1-expressing cells (50% or more). That is a slightly different population from CheckMate-026, which includes patients with a broader range of PD-L1 expression levels. PD-L1 is the ligand that binds to PD-1 receptors on cells.

At the moment BMS' drug has an edge over Keytruda in NSCLC as it is approved for second-line therapy regardless of the PD-L1 status of patients, while Merck's drug is indicated for high PD-L1 expressors only and so requires diagnostic testing before use.

In the first-line setting all patients will likely be required to have their PD-L1 status checked before the checkpoint inhibitors can be prescribed, pitting the two drugs in an even fight and potentially handing a first-mover advantage to Keytruda.

At this year's American Society of Clinical Oncology (ASCO) conference, Merck also presented data from a first-line NSCLC treatment trial looking at the combination of Keytruda and chemotherapy, which suggested remarkable efficacy.

Response rates ranged from 48% to 71%, with the highest effects seen in patients given a combination of Keytruda and Eli Lilly's blockbuster NSCLC therapy Alimta (pemetrexed).

Article by
Phil Taylor

17th June 2016

From: Research

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Creative Medical Research

Specialising in medical device market research and participant recruitment human factors research, our approach is people-centric. We thrive on making...

Latest intelligence

Solaris Health looks at the gene therapy revolution
Gene therapies are bringing new hope for many people with diseases caused by genetic disorders...
PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...

Infographics