Blog Coverage: Merck Receives European Commission Approval for the Treatment of Hodgkin Lymphoma
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LONDON, UK / ACCESSWIRE / May 8, 2017 / Active Wall St. blog coverage looks at the headline from Merck & Co., Inc. (NYSE: MRK) as the Company announced on May 05, 2017, that the European Commission has approved KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, for the treatment of adult patients, with relapsed or refractory classical Hodgkin lymphoma (cHL), who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. Register with us now for your free membership and blog access at:
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Merck stated that the approval was based on the results from the data from the KEYNOTE-087 and KEYNOTE-013 trials conducted on 241 patients. These multicenter, open-label studies evaluated patients with cHL who failed ASCT and BV, who were ineligible for ASCT, or who failed ASCT and did not receive BV. The major efficacy outcome measures, overall response rate (ORR) and complete remission rate (CRR), were assessed by blinded independent central review according to the 2007 revised International Working Group (IWG) criteria.
In KEYNOTE-087, 210 patients received KEYTRUDA (pembrolizumab) at a dose of 200 mg every three weeks until unacceptable toxicity or documented disease progression. Approximately 81% of the patients were refractory to at least one prior therapy, including 35% who were refractory to first-line therapy. Additionally, 61% of patients had undergone prior ASCT. Efficacy analysis showed an ORR of 69% with a CRR of 22% and a partial remission rate (PRR) of 47%. The median follow-up time was 10.1 months. Among the 145 responding patients, the median duration of response was 11.1 months, with 76% of responding patients having responses of six months or longer.
For the KEYNOTE-013 trials, 31 patients received KEYTRUDA at a dose of 10 mg/kg every two weeks until unacceptable toxicity or documented disease progression. 87% of patients were refractory to at least one prior therapy, including 39% who were refractory to first-line therapy. Efficacy analysis showed an ORR of 58% with a CRR of 19% and a PRR of 39%. The median follow-up time was 28.7 months. Among the 18 responding patients, the median duration of response was not reached with 80% of patients with a response of six months or longer and 70 percent of patients with a response of 12 months or longer.
Merck stated that the approval allows the Company to market KEYTRUDA in all 28 EU member states plus Iceland, Lichtenstein, and Norway, at the approved dose of 200 mg every three weeks until disease progression or unacceptable toxicity.
“Today's approval brings an important new treatment option to patients in Europe with classical Hodgkin lymphoma who have not responded to existing therapies,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, “This milestone underscores our commitment to evaluating KEYTRUDA in diseases with unmet need facing the Hematology community.”
What is Hodgkin Lymphoma?
Hodgkin lymphoma is a type of lymphoma that develops in the white blood cells, called lymphocytes, which are part of the immune system. As per the press release, in 2012, there were approximately 66,000 new cases of Hodgkin lymphoma and 25,500 people died from the disease worldwide.
Stock Performance
At the closing bell, on Friday, May 05, 2017, Merck's stock slightly climbed 0.93%, ending the trading session at $63.97. A total volume of 9.33 million shares were traded at the end of the day, which was higher than the 3-month average volume of 8.88 million shares. In the last six months and previous twelve months, shares of the Company have rallied 10.34% and 21.90%, respectively. Moreover, the stock gained 9.45% since the start of the year. The stock is trading at a PE ratio of 40.98 and has a dividend yield of 2.94%.
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