Only anti-PD-1 therapy approved for the treatment of
patients with difficult-to-treat cHL regardless of prior stem cell
transplantation or use of brentuximab vedotina
Merck (MSD has announced that the FDA has approved
Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1)
therapy, for the treatment of adult and pediatric patients with refractory
classical Hodgkin lymphoma (cHL), or who have relapsed after three or more
prior lines of therapy.
Under the FDA’s accelerated approval regulations, this
indication is approved based on tumour response rate and durability of
response. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the confirmatory trials. In
refractory or relapsed cHL, Keytruda is approved for use in adult patients at a
fixed dose of 200 mg and in pediatric patients at a dose of 2 mg/kg (up to a
maximum of 200 mg). Keytruda is administered intravenously every 3 weeks until
disease progression or unacceptable toxicity, or up to 24 months in patients
without disease progression.
The approval is based on data in 210 patients from the
KEYNOTE-087 trial, which demonstrated an overall response rate (ORR) with
Keytruda (200 mg every 3 weeks) of 69% with a complete remission rate (CRR) of
22% and a partial remission rate (PRR) of 47%. The median follow-up time was
9.4 months. Among the 145 responding patients, the median duration of response
was 11.1 months.
“The results from KEYNOTE-087 showed that most
patients with relapsed or refractory classical Hodgkin lymphoma responded to
treatment with Keytruda, and 22% experienced complete remission,” said Dr Roger
M. Perlmutter, president, Merck Research Laboratories. “Today’s approval – the
first for Keytruda in a hematologic malignancy – reinforces the hope that
immunotherapy will prove useful in a wide variety of cancers.”
“For the patients with classical Hodgkin lymphoma who
are not cured with existing treatments, there are limited options, and treating
their disease becomes more challenging,” said Dr Craig Moskowitz, clinical
director, division of hematologic oncology, Memorial Sloan Kettering Cancer
Center. “This approval is an important step forward in treating these patients,
who are generally young and have a particularly poor prognosis, and gives us
the opportunity to help patients in their fight against this devastating
disease.”
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