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News on March 18, 2021 /bioon.
com" target="_blank">/ --Merck & Co recently announced that the European Commission (EC) has approved the anti-PD-1 therapy Keytruda (generic name: pembrolizumab, pembrolizumab) label extension: as a monotherapy , Used to treat age ≥3 years old, accept autologousbioon.
com/course_video/gan-xi-bao-zhi-liao-ji-qi-gui-fan-hua678956.
html">bioon.
com/tags/%E5%B9%B2%E7%BB%86%E8%83%9E/">Adult and pediatric patients with relapsed or refractory classic Hodgkin’s lymphoma (r/r cHL) who have failed the treatment of bioon.
com/tags/%E5%B9%B2%E7%BB%86%E8%83%9E/">stem cell transplantation (ASCT) or have received at least 2 previous therapies when ASCT is not suitable as a treatment option .
It is worth mentioning that this is the first pediatric indication for Keytruda approved by the European Union.
bioon.com" target="_blank">/ --Merck & Co recently announced that the European Commission (EC) has approved the anti-PD-1 therapy Keytruda (generic name: pembrolizumab, pembrolizumab) label extension: as a monotherapy , Used to treat age ≥3 years old, accept autologousbioon.
com/course_video/gan-xi-bao-zhi-liao-ji-qi-gui-fan-hua678956.
html">bioon.
com/tags/%E5%B9%B2%E7%BB%86%E8%83%9E/">Adult and pediatric patients with relapsed or refractory classic Hodgkin’s lymphoma (r/r cHL) who have failed the treatment of bioon.
com/tags/%E5%B9%B2%E7%BB%86%E8%83%9E/">stem cell transplantation (ASCT) or have received at least 2 previous therapies when ASCT is not suitable as a treatment option .
It is worth mentioning that this is the first pediatric indication for Keytruda approved by the European Union.
com" target="_blank">bioon.
com/course_video/gan-xi-bao-zhi-liao-ji-qi-gui-fan-hua678956.
html">bioon.
com/tags/%E5%B9%B2%E7%BB%86%E8%83%9E/">Stem cell This is the first pediatric indication for Keytruda approved by the European Union.
In October 2020, the US FDA approved Keytruda as a single-drug therapy for second-line treatment of relapsed or refractory classic Hodgkin lymphoma (r/r cHL) adult patients.
Keytruda is the first anti-PD-L1 therapy approved for adult patients with relapsed or refractory cHL after receiving first-line treatment.
In addition, the bioon.
com/fda/" target="_blank">FDA has also approved the update of Keytruda's pediatric indications for the treatment of children with refractory cHL, or children with cHL who have relapsed after receiving 2 or more therapies.
bioon. Keytruda is the first anti-PD-L1 therapy approved for adult patients with relapsed or refractory cHL after receiving first-line treatment.
In addition, the bioon.
com/fda/" target="_blank">FDA has also approved the update of Keytruda's pediatric indications for the treatment of children with refractory cHL, or children with cHL who have relapsed after receiving 2 or more therapies.
com/fda/" target="_blank">FDA
The EU approval is based on the results of the key head-to-head key phase III KEYNOTE-204 trial (NCT02684292).
The data shows that in patients with r/r cHL, Keytruda will progress or die compared with the standard care drug Adcetris (Chinese trade name: Anshili, generic name: brentuximab vedotin, BV, vedotin for injection) The risk was significantly reduced by 35% (HR=0.
65[95%CI:0.
48-0.
88]; p=0.
00271), and the progression-free survival (PFS) was significantly prolonged (median PFS: 13.
2 months vs 8.
3 months).
The data shows that in patients with r/r cHL, Keytruda will progress or die compared with the standard care drug Adcetris (Chinese trade name: Anshili, generic name: brentuximab vedotin, BV, vedotin for injection) The risk was significantly reduced by 35% (HR=0.
65[95%CI:0.
48-0.
88]; p=0.
00271), and the progression-free survival (PFS) was significantly prolonged (median PFS: 13.
2 months vs 8.
3 months).
These data are particularly meaningful because approximately 15%-20% of patients with cHL (the most common type of Hodgkin’s lymphoma) usually do not get remission after first-line treatment.
These patients are generally very young, and if remission cannot be achieved, the prognosis will be poor.
Data from the KEYNOTE-204 trial shows that Keytruda monotherapy has the potential to change the current treatment model for cHL patients.
These patients are generally very young, and if remission cannot be achieved, the prognosis will be poor.
Data from the KEYNOTE-204 trial shows that Keytruda monotherapy has the potential to change the current treatment model for cHL patients.
In addition, the EU approval is also based on supporting data from the latest analysis of the KEYNOTE-087 trial.
This trial supports the previous European Commission (EC) approval of Keytruda for the treatment of r/r cHL adult patients who have failed ASCT and BV or are not eligible for transplantation and BV has failed.
This trial supports the previous European Commission (EC) approval of Keytruda for the treatment of r/r cHL adult patients who have failed ASCT and BV or are not eligible for transplantation and BV has failed.
Dr.
Vicki Goodman, Vice President of Clinical Research at Merck Research Laboratories, said: "The European Commission approved the expansion of Keytruda use, which provides an alternative treatment option for adults and pediatric patients with cHL who have disease progression or relapse after transplantation after early treatment.
We are committed to advancing treatment to help improve the prognosis of blood cancer patients, including those with relapsed or refractory cHL.
"
Vicki Goodman, Vice President of Clinical Research at Merck Research Laboratories, said: "The European Commission approved the expansion of Keytruda use, which provides an alternative treatment option for adults and pediatric patients with cHL who have disease progression or relapse after transplantation after early treatment.
We are committed to advancing treatment to help improve the prognosis of blood cancer patients, including those with relapsed or refractory cHL.
"
Classical Hodgkin's Lymphoma (cHL, image source: atlasgeneticsoncology.
org)
org)
Adcetris (Chinese trade name: comfortable advantage, injection cloth rituximab) is Takeda Pharmaceuticals and Seattle bioon.
com/course_video/zhong-guo-ren-qun-ying-yang-he-yi-chuan-yin416058.
html">Genetic study developed a targeting CD30 antibody drug conjugate (ADC), the treatment of r / r cHL of Standard care medicine.
In China, Adcetris was officially approved by the National Food and Drug Administration (NMPA) in mid-May 2020 to treat relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) or CD30-positive Hodgkin lymphoma Adult patients with tumors (HL).
bioon. com/course_video/zhong-guo-ren-qun-ying-yang-he-yi-chuan-yin416058.
html">Genetic study developed a targeting CD30 antibody drug conjugate (ADC), the treatment of r / r cHL of Standard care medicine.
In China, Adcetris was officially approved by the National Food and Drug Administration (NMPA) in mid-May 2020 to treat relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) or CD30-positive Hodgkin lymphoma Adult patients with tumors (HL).
com/course_video/zhong-guo-ren-qun-ying-yang-he-yi-chuan-yin416058.
html">Genetic
KEYNOTE-204 is the first phase III trial to evaluate an anti-PD-1 therapy for the treatment of r/r cHL with positive results.
This is a randomized, open-label, head-to-head Phase III trial that evaluates the efficacy and safety of Keytruda monotherapy and BV in the treatment of r/r cHL.
The trial enrolled 304 adult patients ≥18 years of age.
These patients were randomly assigned to receive Keytruda (200 mg intravenous infusion, administered on the first day of each cycle, every 3 weeks as a cycle, and 35 cycles of treatment ) Or BV (1.
8mg/kg [maximum dose 180mg], administered on the first day of each cycle, every 3 weeks as a cycle, 35 cycles of treatment) treatment.
The common primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS).
Key secondary endpoints include objective response rate (ORR), complete response rate (CR), and safety.
This is a randomized, open-label, head-to-head Phase III trial that evaluates the efficacy and safety of Keytruda monotherapy and BV in the treatment of r/r cHL.
The trial enrolled 304 adult patients ≥18 years of age.
These patients were randomly assigned to receive Keytruda (200 mg intravenous infusion, administered on the first day of each cycle, every 3 weeks as a cycle, and 35 cycles of treatment ) Or BV (1.
8mg/kg [maximum dose 180mg], administered on the first day of each cycle, every 3 weeks as a cycle, 35 cycles of treatment) treatment.
The common primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS).
Key secondary endpoints include objective response rate (ORR), complete response rate (CR), and safety.
The results showed that the study reached one of the dual primary endpoints of progression-free survival (PFS).
According to an interim analysis conducted by the Independent Data Monitoring Committee (DMC), in this patient population, the Keytruda treatment group achieved a statistically significant and clinically significant improvement in PFS compared with the BV treatment group.
The specific data are: Compared with the BV group, the risk of disease progression or death in the Keytruda group was significantly reduced by 35% (HR=0.
65 [95%CI: 0.
48-0.
88], p=0.
00271), and PFS was significantly prolonged (median PFS: 13.
2) Months vs.
8.
3 months) and one-year progression-free survival rate improved (53.
9% vs 35.
6%).
In addition, the ORR of the Keytruda group was 65.
6% and that of the BV group was 35.
6%; the partial response rate (PR) of the Keytruda group was 41.
1%, and that of the BV group was 30.
1%.
The median duration of response (DOR) in the Keytruda group was 20.
7 months (range: 0.
0+ to 33.
2+), and that in the BV group was 13.
8% (range: 0.
0+ to 33.
9+).
According to an interim analysis conducted by the Independent Data Monitoring Committee (DMC), in this patient population, the Keytruda treatment group achieved a statistically significant and clinically significant improvement in PFS compared with the BV treatment group.
The specific data are: Compared with the BV group, the risk of disease progression or death in the Keytruda group was significantly reduced by 35% (HR=0.
65 [95%CI: 0.
48-0.
88], p=0.
00271), and PFS was significantly prolonged (median PFS: 13.
2) Months vs.
8.
3 months) and one-year progression-free survival rate improved (53.
9% vs 35.
6%).
In addition, the ORR of the Keytruda group was 65.
6% and that of the BV group was 35.
6%; the partial response rate (PR) of the Keytruda group was 41.
1%, and that of the BV group was 30.
1%.
The median duration of response (DOR) in the Keytruda group was 20.
7 months (range: 0.
0+ to 33.
2+), and that in the BV group was 13.
8% (range: 0.
0+ to 33.
9+).
According to the pre-specified analysis plan, in this interim analysis, the other common primary endpoint, OS, was not formally tested.
The study will continue to evaluate OS.
In terms of safety, the incidence of treatment-related adverse events (TRAE) was similar in the Keytruda group (74.
3%) and the BV group (77.
0%).
The incidence of grade 3-5 TRAE was lower in the Keytruda group (19.
6%) than in the BV group (25.
0%).
One treatment-related death (pneumonia) occurred in the Keytruda group.
()
The study will continue to evaluate OS.
In terms of safety, the incidence of treatment-related adverse events (TRAE) was similar in the Keytruda group (74.
3%) and the BV group (77.
0%).
The incidence of grade 3-5 TRAE was lower in the Keytruda group (19.
6%) than in the BV group (25.
0%).
One treatment-related death (pneumonia) occurred in the Keytruda group.
()
Original source: European Commission app roves Expanded Indication for Merck's KEYTRUDA? (pembrolizumab) in Adult and Pediatric Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)
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