To March 14, 2017, pharmaceutical giant Merck announced that its immunotherapy drug Keytruda (Pembrolizumab) FDA approved for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma, or accept the three line and multi line treatment after disease recurrence of classical Hodgkin lymphoma (cHL) patients.
This approval is mainly based on the rate of tumor remission and the duration of remission.
KEYNOTE-087 entry group:
A KEYNOTE-087 clinical trial was approved to include 210 patients with recurrent or refractory cHL, with a median follow-up of 9.4 months.
The exclusion criteria include active, non infectious pneumonia, or over the past five years (or more than 5 years.
GVHD symptoms include allogeneic stem cell transplantation, active autoimmune disease, immunosuppressive therapy, and active systemic infection.
In the 58% patients with poor efficacy in the last treatment, including 35% of the refractory patients and 14% were resistant to all existing chemotherapy patients. In addition, 61% of the patients had received autologous stem cell transplantation, 17% of them had not received Brentuximab Vedotin (SGN35) treatment, and 36% had received radiotherapy.
utility
The overall remission rate of KEYTRUDA (200mg/3 weeks) was 69%, of which the complete remission rate was 22%, and the partial remission rate (over 30% of the tumor rate) was 47%. 145 of the remission patients, the median remission duration reached 11.1 months.
Approved dose:
The dosage of children and adults is different. Adults have a fixed dose of 200mg, and children are 2mg/kg (maximum dose 200mg). They are used once a week for 3 weeks until the disease progresses or is not tolerable, or they are used for 24 months without progression.
Side effect：
In 210 patients with cHL approved test in 5% patients because of adverse reaction of Keytruda and 26% of patients discontinued medication because of adverse temporary withdrawal, 15% patients appeared to accept systemic adverse reactions of corticosteroid treatment, 16% patients had serious adverse reaction.
The most common side effects (&ge, 20%) were fatigue (26%), fever (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%%).
Side effects of children:
In the case of adverse reactions, the experience of this clinical trial is very limited in pediatric patients. The efficacy of pediatric patients is deduced from the clinical results of the adult cHL population.
In the study of 40 children, including advanced melanoma, PD-L1 positive late relapse or male paper solid tumor or lymphoma, the median of Keytruda treatment in children was 43 days (1-414 days), and 24 children received treatment for 42 days or more. The safety of Keytruda is similar to that of adults in the performance of children.
The incidence of adverse events was higher in children than adults under 65 years old (&ge, 15%), mainly fatigue (45%), vomiting (38%), abdominal pain (28%), hyperaminotransferase (28%) and hyponatremia (18%).
About Keytruda
Keytruda has been approved for the treatment of classic Hodgkin's lymphoma, which again seems to prove that the drug may be brilliant in the treatment of a variety of cancers.
Prior to this, the drug has been approved for metastatic head and neck squamous cell carcinoma in the treatment of advanced melanoma, non-small cell lung cancer, even in 2016, success beyond chemotherapy, FDA approved for the treatment of PD-L1 among the high [removed]>50%) as first-line therapy for metastatic non-small cell lung cancer.
In addition, Keytruda is effective not only in the above three approved cancer treatments, but also in many other types of tumors, such as colon cancer, bladder cancer, multiple myeloma and so on. In 2016, Merck in the ASCO meeting that the trial of Keytruda has involved more than 30 types of cancer, the number of more than 270. Of these, nearly one hundred clinical trials are combined with the combination of Keytruda and other therapies, and some of the studies have shown preliminary results.
New treatment and children's tumor:
In fact, despite immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors, tumor immunotherapy attempts in children never ceased, such as immunity in patients with advanced neuroblastoma in treatment plays a very important role, in addition, such as CAR-T, molecular scissors and other miracle gene editing technology are also in the treatment of children with cancer in bring us one after another. It is hoped that the approval of this PD-1 inhibitor will lead to more clinical trials and more hope and possibility for children.
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