The FDA Approved Pembrolizumab for Another Indication
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<strong>The</strong> <strong>FDA</strong> <strong>Approved</strong> <strong>Pembrolizumab</strong> <strong>for</strong> <strong>Another</strong> <strong>Indication</strong><br />
On March 14, 2017, the <strong>FDA</strong> approved pembrolizumab <strong>for</strong> the treatment of Classical Hodgkin<br />
lymphoma (CHL) indications of adults and children who have previously received therapies<br />
superior than third-line therapy. It won another “city” <strong>for</strong> immunotherapy in the anti-tumor "war".<br />
<strong>Pembrolizumab</strong> is the only PD-1 inhibitor that has currently been approved by the <strong>FDA</strong> <strong>for</strong><br />
Classical Hodgkin lymphoma (CHL) and is also available to patients who have previously<br />
received hematopoietic stem cell transplantation (HSCT) or Brentuximab therapy.<br />
Research Details<br />
<strong>The</strong> <strong>FDA</strong> approved the sample based on the KEYNOTE-087 study. This study enrolled 210<br />
patients, and gave them the treatment of 200 mg of pembrolizumab at 21d/cycle.<br />
Of the 210 enrolled patients, 58% received resistance to the previous regimen. 35% of the patients<br />
were diagnosed as refractory preliminarily. 14% of the patients were resistant to all previous<br />
regimens. 61% of patients had received HSCT previously. 17% of the patients had not previously<br />
received brentuximab treatment. 36% of the patients received radiotherapy previously.<br />
Results<br />
<strong>The</strong> median follow-up time was 9.4 months. <strong>The</strong> overall response rate (ORR: PR + CR) was 69%.<br />
<strong>The</strong> complete remission rate was 22%.<br />
<strong>The</strong> median response duration (DoR) was 11.1 months.<br />
In terms of safety, 5% of the patients discontinued the treatment due to side effects. 26% of them<br />
interrupted the treatment. 5% of them needed systemic hormone therapy because of side effects.<br />
<strong>The</strong> most common side effects were fatigue (26%), fever (24%), cough (24%) and skeletal muscle<br />
pain (21%), diarrhea (20%) and rashes (20%).
Severe side effects occurred in 16% of patients with the common ones including pneumonia, fever,<br />
dyspnea, graft-versus-host disease (GVHD) and herpes zoster.<br />
Two patients died due to disease progression. One died of GVHD after allotransplant, and the<br />
other died of septic shock.<br />
Summary<br />
KEYNOTE-087 indicates that <strong>Pembrolizumab</strong> is effective in treating most recurrent or resistant<br />
Classical Hodgkin lymphoma.<br />
Craig, professor of Memorial Sloan-Kettering Cancer Center, and Roger, professor of Merck<br />
Research Laboratories commented on this study.<br />
Professor Roger said that <strong>Pembrolizumab</strong>'s approval today showed that immune checkpoint<br />
inhibitors might have potential to be used widely in many cancers.<br />
As <strong>for</strong> children, <strong>Pembrolizumab</strong> has limited data on the treatment of children with Hodgkin's<br />
lymphoma and its validity is based on an exploration of adult trials.<br />
Safety considerations <strong>for</strong> pediatric use are based on a mixed study of 40 advanced, PD-L1-positive<br />
advanced melanomas, recurrent or refractory solid tumors or lymphoma.<br />
Drug safety is similar <strong>for</strong> both adults and children. Among children, the incidence of side effects<br />
increased by about 15%, which mainly include fatigue, nausea, abdominal pain, hyperlipidemia,<br />
hyponatremia and so on.<br />
Professor Craig pointed out that CHLs which cannot be treated with existing therapies offer<br />
particularly limited choices and great challenges <strong>for</strong> patients. <strong>Pembrolizumab</strong>'s approval gave<br />
CHL patients a chance. After all, most of these patients are very young, while the prognosis is still<br />
poor. <strong>The</strong>re<strong>for</strong>e, they need such disease-resistant weapon.
About Author<br />
Creative Biolabs is a biotech company specialized in providing custom biotechnology and<br />
pharmaceutical services that cover the full scope of biotechnology needs of early antibody drug<br />
discovery and development, such as biosimilar monoclonal antibodies, fab antibodies, etc.<br />
http://www.medicalmingle.com/biotech/blog/2017/12/14/the_fda_approved_pembrolizumab_<strong>for</strong>_<br />
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