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▎The content team editor of WuXi AppTec today, ADC Therapeutics announced its new antibody conjugate drug (ADC) camidanlumab tesirine (Cami) targeting CD25 for the treatment of relapsed/refractory Hodgkin and non-Hodgkin’s lymphoma The patient's Phase 1 clinical trial results were published on The Lancet Haematology.
The results of the trial showed that in patients with Hodgkin’s lymphoma treated with the recommended starting dose of Cami in the Phase 2 clinical trial, Cami achieved an overall response rate (ORR) of 86%.
ADC is a new type of drug consisting of a monoclonal antibody targeting a specific tumor-associated antigen and a payload coupled to the antibody, combining the targeted delivery of monoclonal antibodies with the tumor-killing potential of the payload.
Cami is produced by coupling a monoclonal antibody that binds to CD25 and a dimer of pyrrole benzodiazepine (PBD).
Once bound to cells expressing CD25, it will be internalized by the cell.
There, the protease releases the PBD-based payload, killing the cell.
This process may also kill neighboring tumor cells and has also been shown to induce immunogenic cell death.
All these properties of Cami may enhance immune-mediated anti-tumor activity.
In April of this year, ADC Therapeutics developed the CD19-targeting antibody conjugate drug Zynlonta (loncastuximab tesirine-lpyl), which was approved by the FDA for accelerated listing.
It also uses the unique cytotoxin of PBD dimer.▲The pyrrole benzodiazepine (PBD) dimer cytotoxin has a unique mechanism of action (picture source: ADC Therapeutics official website) This multi-center, open-label, single-group phase 1 clinical trial enrolled 133 adult patients, of which 77 cases (58%) had classic Hodgkin’s lymphoma, and 56 cases (42%) had non-Hodgkin’s lymphoma.
The key results of the trial include: the ORR of the total patient group was 58%, and 38 of the 130 patients (29%) achieved complete remission.
Among patients with Hodgkin's lymphoma treated with different doses of Cami, the ORR was 71%, and 32 of 77 patients (42%) achieved complete remission.
Specifically, in patients with Hodgkin’s lymphoma who received 45 μg/kg (the recommended starting dose for the Phase 2 trial), the ORR was 86%, and 18 of the 37 patients had a complete remission.
In addition, in patients with Hodgkin's lymphoma who received 30 μg/kg, the ORR was 55%, and 7 of the 20 patients had a complete remission.
Among patients with non-Hodgkin's lymphoma, the ORR was 38%, and 5 of 53 patients achieved complete remission.
The total median duration of remission for all patients with Hodgkin’s lymphoma was 6.
6 months, compared to 7.
2 months for patients with Hodgkin’s lymphoma who received the 45 μg/kg dose.
In terms of safety, Cami has acceptable safety.
The most common adverse events include elevated liver enzymes (without liver synthesis dysfunction), skin rash, fatigue, edema or fluid accumulation, and nausea.
In addition, the ongoing key phase 2 clinical trial interim data shows that Cami's anti-tumor activity as a single agent is encouraging, with an ORR of 83%, a complete remission rate of 38%, and no new safety signals.
.
These data highlight Cami's potential to address the unmet needs of patients who have received multiple pre-treatments.
The lead author of the paper, Professor Mehdi Hamadani, said: “There is still a significant unmet medical need for novel therapies to improve the prognosis of patients with relapsed/refractory Hodgkin’s lymphoma.
This patient group usually has received a large number of preliminary treatments.
In this study, the median number of patients who have received systemic treatments in the past is 5 times.
The results of the Phase 1 study prove that Cami has inspiring potential and can provide a new treatment option for patients with relapsed/refractory Hodgkin's lymphoma.
"Reference: [1] ADC Therapeutics Announces Online Publication of Camidanlumab Tesirine Phase 1 Results in The Lancet Haematology.
May 26, 2021, fromNote: The purpose of this article The introduction of medical and health research progress is not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital for treatment.
The results of the trial showed that in patients with Hodgkin’s lymphoma treated with the recommended starting dose of Cami in the Phase 2 clinical trial, Cami achieved an overall response rate (ORR) of 86%.
ADC is a new type of drug consisting of a monoclonal antibody targeting a specific tumor-associated antigen and a payload coupled to the antibody, combining the targeted delivery of monoclonal antibodies with the tumor-killing potential of the payload.
Cami is produced by coupling a monoclonal antibody that binds to CD25 and a dimer of pyrrole benzodiazepine (PBD).
Once bound to cells expressing CD25, it will be internalized by the cell.
There, the protease releases the PBD-based payload, killing the cell.
This process may also kill neighboring tumor cells and has also been shown to induce immunogenic cell death.
All these properties of Cami may enhance immune-mediated anti-tumor activity.
In April of this year, ADC Therapeutics developed the CD19-targeting antibody conjugate drug Zynlonta (loncastuximab tesirine-lpyl), which was approved by the FDA for accelerated listing.
It also uses the unique cytotoxin of PBD dimer.▲The pyrrole benzodiazepine (PBD) dimer cytotoxin has a unique mechanism of action (picture source: ADC Therapeutics official website) This multi-center, open-label, single-group phase 1 clinical trial enrolled 133 adult patients, of which 77 cases (58%) had classic Hodgkin’s lymphoma, and 56 cases (42%) had non-Hodgkin’s lymphoma.
The key results of the trial include: the ORR of the total patient group was 58%, and 38 of the 130 patients (29%) achieved complete remission.
Among patients with Hodgkin's lymphoma treated with different doses of Cami, the ORR was 71%, and 32 of 77 patients (42%) achieved complete remission.
Specifically, in patients with Hodgkin’s lymphoma who received 45 μg/kg (the recommended starting dose for the Phase 2 trial), the ORR was 86%, and 18 of the 37 patients had a complete remission.
In addition, in patients with Hodgkin's lymphoma who received 30 μg/kg, the ORR was 55%, and 7 of the 20 patients had a complete remission.
Among patients with non-Hodgkin's lymphoma, the ORR was 38%, and 5 of 53 patients achieved complete remission.
The total median duration of remission for all patients with Hodgkin’s lymphoma was 6.
6 months, compared to 7.
2 months for patients with Hodgkin’s lymphoma who received the 45 μg/kg dose.
In terms of safety, Cami has acceptable safety.
The most common adverse events include elevated liver enzymes (without liver synthesis dysfunction), skin rash, fatigue, edema or fluid accumulation, and nausea.
In addition, the ongoing key phase 2 clinical trial interim data shows that Cami's anti-tumor activity as a single agent is encouraging, with an ORR of 83%, a complete remission rate of 38%, and no new safety signals.
.
These data highlight Cami's potential to address the unmet needs of patients who have received multiple pre-treatments.
The lead author of the paper, Professor Mehdi Hamadani, said: “There is still a significant unmet medical need for novel therapies to improve the prognosis of patients with relapsed/refractory Hodgkin’s lymphoma.
This patient group usually has received a large number of preliminary treatments.
In this study, the median number of patients who have received systemic treatments in the past is 5 times.
The results of the Phase 1 study prove that Cami has inspiring potential and can provide a new treatment option for patients with relapsed/refractory Hodgkin's lymphoma.
"Reference: [1] ADC Therapeutics Announces Online Publication of Camidanlumab Tesirine Phase 1 Results in The Lancet Haematology.
May 26, 2021, fromNote: The purpose of this article The introduction of medical and health research progress is not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital for treatment.