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Keytruda closes in on Opdivo's lead in Hodgkin lymphoma

KEYNOTE-087 trial shows an overall response rate of 69 percent

Merck and CoFor a few months Bristol-Myers Squibb's Opdivo has been the only checkpoint inhibitor approved for Hodgkin lymphoma, but rival Merck & Co is working to close the gap.

Merck filed for approval of Keytruda (pembrolizumab) as a treatment for relapsed or refractory Hodgkin lymphoma a few days ago, and has just reported the clinical data behind that marketing application at the American Society of Hematology (ASH) conference in San Diego.

In the KEYNOTE-087 trial, Keytruda achieved an overall response rate of 69%, with just over 22% of patients going into complete remission. Meanwhile, two-year follow-up data from another trial (KEYNOTE-013) showed an overall response rate of 58% and 19% of patients in complete remission.

"As the data matures from these two studies, we continue to be encouraged by the response rates, including complete remission and durable responses, in patients with relapsed or refractory classical Hodgkin lymphoma," commented Merck's Roger Dansey, who leads the company's late-stage cancer development programmes.

Keytruda has already been awarded breakthrough designation in Hodgkin lymphoma and if all goes according to plan could get a green light from the FDA by 15 March next year for patients who have relapsed after three or more prior lines of therapy. 

Opdivo (nivolumab) was approved in the US for Hodgkin lymphoma last May, getting the go-ahead for use in adult patients who have previously received an autologous stem cell transplant and treatment with Seattle Genetics/Takeda's Adcetris (brentuximab vedotin) - the current standard of care.

If approved, Keytruda will edge closer to Opdivo (nivolumab) in the market, although with only around 8,500 new cases per year in the US, Hodgkin lymphoma will not be a game-changer. BMS' drug has outsold its rival to date thanks largely to a speedier roll-out of new indications and - more recently - weaker data in the big non-small cell lung cancer (NSCLC) therapeutic category.

Keytruda brought in $919m in revenues for Merck in the first nine months of the year - up 161% on the same period of 2015 - while Opdivo grew five-fold to $2.46bn.

Article by
Phil Taylor

6th December 2016

From: Research

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