The FDA Approved Pembrolizumab for Another Indication

On March 14, 2017, the FDA approved pembrolizumab for the treatment of Classical Hodgkin
lymphoma (CHL) indications of adults and children who have previously received therapies
superior than third-line therapy. It won another “city” for immunotherapy in the anti-tumor "war".

Pembrolizumab is the only PD-1 inhibitor that has currently been approved by the FDA for
Classical Hodgkin lymphoma (CHL) and is also available to patients who have previously
received hematopoietic stem cell transplantation (HSCT) or Brentuximab therapy.

Research Details

The FDA approved the sample based on the KEYNOTE-087 study. This study enrolled 210
patients, and gave them the treatment of 200 mg of pembrolizumab at 21d/cycle.

Of the 210 enrolled patients, 58% received resistance to the previous regimen. 35% of the patients
were diagnosed as refractory preliminarily. 14% of the patients were resistant to all previous
regimens. 61% of patients had received HSCT previously. 17% of the patients had not previously
received brentuximab treatment. 36% of the patients received radiotherapy previously.

Results

The median follow-up time was 9.4 months. The overall response rate (ORR: PR + CR) was 69%.
The complete remission rate was 22%.

The median response duration (DoR) was 11.1 months.

In terms of safety, 5% of the patients discontinued the treatment due to side effects. 26% of them
interrupted the treatment. 5% of them needed systemic hormone therapy because of side effects.

The most common side effects were fatigue (26%), fever (24%), cough (24%) and skeletal muscle
pain (21%), diarrhea (20%) and rashes (20%).
Severe side effects occurred in 16% of patients with the common ones including pneumonia, fever,
dyspnea, graft-versus-host disease (GVHD) and herpes zoster.

Two patients died due to disease progression. One died of GVHD after allotransplant, and the
other died of septic shock.

Summary

KEYNOTE-087 indicates that Pembrolizumab is effective in treating most recurrent or resistant

Classical Hodgkin lymphoma.

Craig, professor of Memorial Sloan-Kettering Cancer Center, and Roger, professor of Merck
Research Laboratories commented on this study.

Professor Roger said that Pembrolizumab's approval today showed that immune checkpoint
inhibitors might have potential to be used widely in many cancers.

As for children, Pembrolizumab has limited data on the treatment of children with Hodgkin's
lymphoma and its validity is based on an exploration of adult trials.

Safety considerations for pediatric use are based on a mixed study of 40 advanced, PD-L1-positive
advanced melanomas, recurrent or refractory solid tumors or lymphoma.

Drug safety is similar for both adults and children. Among children, the incidence of side effects
increased by about 15%, which mainly include fatigue, nausea, abdominal pain, hyperlipidemia,
hyponatremia and so on.

Professor Craig pointed out that CHLs which cannot be treated with existing therapies offer
particularly limited choices and great challenges for patients. Pembrolizumab's approval gave
CHL patients a chance. After all, most of these patients are very young, while the prognosis is still
poor. Therefore, they need such disease-resistant weapon.
About Author

Creative Biolabs is a biotech company specialized in providing custom biotechnology and

pharmaceutical services that cover the full scope of biotechnology needs of early antibody drug
discovery and development, such as biosimilar monoclonal antibodies, fab antibodies, etc.

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