Please login to the form below

Not currently logged in
Email:
Password:

Keytruda hits primary endpoint in confirmatory lymphoma trial

Interim analysis demonstrates improvement in progression-free survival

Merck

Merck & Co/MSD’s Keytruda has hit the primary endpoint in a confirmatory phase 3 trial in classical Hodgkin lymphoma (cHL), three years after scoring approval for the treatment of this type of cancer.

In March 2017, Keytruda (pembrolizumab) picked up a conditional approval for the treatment of adult and paediatric patients with refractory cHL, or who have relapsed after three or more prior lines fo therapy.

It was the first green light for the drug in a haematological cancer, and Keytruda has since gone on to receive approval in primary mediastinal B-cell lymphoma, a rare form of B-cell non-Hodgkin lymphoma.

Merck scored the cHL approval on the back of the phase 2 KEYNOTE-087 trial, with this most recent phase 3 trial – KEYNOTE-204 – providing more detailed results that demonstrate the checkpoint inhibitor has a solid effect in the blood cancer.

The trial compared Keytruda to Seattle Genetic’s antibody-drug conjugate Adcetris – a standard treatment for relapsed and refractory lymphoma.

Merck’s drug beat Adcetris in terms of progression-free survival (PFS), according to an interim review by an independent data monitoring committee.

As this is just an interim analysis, the detailed results of just how much Keytruda topped its rival are not yet available, but PFS is a primary endpoint of the study, so its a success all the same for Merck.

“Patients with classical Hodgkin lymphoma are generally young and when they do not achieve remission following standard treatment, their cancer is challenging to treat,” said Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories.

“These pivotal phase 3 data indicate a statistically significant and clinically meaningful improvement in progression-free survival with Keytruda compared, in head to head fashion, with the currently approved therapy of Adcetris,” he added.

The other dual primary endpoint of the study – the more robust overall survival rate – was not tested at the interim analysis.

Keytruda’s main growth indication is undoubtedly non-small cell lung cancer, a therapy area which will likely help the PD-1 inhibitor to win $22.5bn in sales by 2025, as predicted by GlobalData.

CHL is, in comparison to Keytruda’s other indications, not quite as important. Still, this trial works to confirm the drug’s efficacy in the blood cancer, and the results are an encouraging sign for Merck, which has two other cHL trials for Keytruda currently underway.

That includes evaluating Keytruda in combination with chemotherapy in children and young adults in first-line cHL and in the post-Adcetris treatment setting.

Article by
Lucy Parsons

5th March 2020

From: Research

Share

Tags

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Health Unlimited

Health Unlimited is a global health consultancy and communications agency built by specialists with unmatched experience, perspective and expertise. For...

Latest intelligence

reaching HCPs during pandemic
Reaching patients and HCPs during the pandemic
COVID-19 has caused unprecedented disruption to drug launches, but some pharma companies avoided costly delays by quickly pivoting to digital channels...
#DemandDiversity: Black history in clinical trials: It's more than just Tuskegee [Infographic]
Take a look at this infographic showing some of the most notorious clinical trials and medical research in history....
Looking back at the year when everything changed
COVID-19 has impacted every aspect of our lives, from the way we shop for groceries to the way we conduct work and interact with healthcare providers and our families....

Infographics