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Recent popular reports from Yimaike★ Hot nucleic acid drugs! Come and see what types of nucleic acid drugs are available.
Yimai Meng broke the news.
NK cell therapy of placenta origin, allogeneic and natural killer won the FDA orphan drug title for the treatment of glioblastoma Yimai Meng broke the news in 2021 April 17 / eMedClub News/--Classic Hodgkin's Lymphoma (cHL) is one of the most common malignant tumors in young people, so it has attracted more and more attention from the medical community and society.
Patients with relapsed/refractory cHL (R/R cHL) usually receive high-dose chemotherapy combined with autologous hematopoietic stem cell transplantation (ASCT), but the recurrence rate is high, the overall survival time is short, and there are serious treatment-related toxic and side effects.
Programmed death receptor 1 (PD-1) monotherapy has shown outstanding therapeutic effects in R/R cHL, but many patients will develop resistance to PD-1 inhibitors, and only some patients can achieve lasting remission .
Therefore, exploring new R/R cHL treatment options has important clinical significance.
Recently (April 5, 2021), the Journal for ImmunoTherapy of Cancer (JITC) published online a clinical research paper by Professor Han Weidong’s team at the PLA General Hospital, entitled "Improved clinical outcome in a randomized phase II study" of anti-PD-1 camrelizumab plus decitabine in relapsed/refractory Hodgkin lymphoma".
The study showed that in patients with R/R cHL, decitabine combined with the anti-PD-1 drug carrelizumab, compared with carrelizumab monotherapy, had a significant progression-free survival (PFS) extend.
Decitabine, as an epigenetic modifier, can reduce DNA methylation by inhibiting DNA methyltransferase.
Previously, Professor Han Weidong’s team found that low-dose decitabine can enhance T cell activity and improve the level of T cell exhaustion (Reference 3).
The combined use of Decitabine and PD-1 antibody has a synergistic effect and can improve the body's immune surveillance performance against tumors.
In 2019, the team published an article in the Journal of Clinical Oncology reporting the clinical efficacy of decitabine and PD1 antibody in combination with sensitization and potentiation of PD1 antibody in cHL (Reference 4).
In March of this year, further follow-up data from clinical trials were published in the Journal of Clinical Cancer Research, indicating that this combination therapy can achieve high remission rates and long-term benefits (Reference 2).
The study published on JITC included 61 patients with R/R cHL who were enrolled in a multi-center, phase 2 clinical trial (NCT02961101; NCT03250962) from January 2017 to July 2018.
These patients have failed second-line and above treatment options and have not received anti-PD-1 drug therapy in the past.
Patients were randomly assigned at a ratio of 1:2 and received carrelizumab (200 mg) monotherapy, or decitabine (10 mg/day, days 1-5) + carrelizumab ( 200mg, 8th day) combined treatment, every 3 weeks course of treatment.
▲ Study design (Image source: JITC) The median follow-up time of the study was 34.
5 months.
At the last follow-up, the complete response rate (CR) of the decitabine + carrelizumab combination treatment group was 79%, and the overall response rate (ORR) was 95%; the carrelizumab monotherapy group had CR Is 32% and ORR is 89%.
It is important that after long-term treatment, another patient in the decitabine + carrelizumab group achieved CR, and two of them achieved CR in the second year of the combined treatment.
Therefore, this report The data is higher than the previous study (Reference 4).
In the study, the median duration of response (DOR) was not reached in the combined treatment group, and the median DOR in the monotherapy group was 12.
7 months.
The proportion of patients in the combination therapy group who were still in remission at 2 years was 63%; in the monotherapy group, it was 35%.
▲DOR of CR and PR patients (picture source: JITC) The median progression-free survival (PFS) of the combined treatment group was 35 months, and that of the monotherapy group was 15.
5 months; the 2-year PFS rates of the two groups were 67 % And 42% (combination therapy group vs.
monotherapy group).
In most demographic and clinical subgroups, the PFS benefit observed with combination therapy is better than that of monotherapy, especially for patients with larger tumor burden and previous multiple-line therapy, in PD-1 therapy Adding decitabine can solve the urgent treatment needs of this population.
▲ In addition to the PFS of all 61 patients (picture source: JITC), the study also observed that with decitabine combined treatment, the percentage of circulating peripheral central memory T cells (Tcm) increased significantly, suggesting that this indicator is clinically relevant There is a direct correlation between remission and PFS, and it is expected to be an effective functional biomarker for predicting clinical remission and prognosis after decitabine+calorie combination therapy.
▲ Percentage of circulating peripheral central memory T cells (picture source: JITC) The safety characteristics of decitabine + carrelizumab are consistent with the team’s previous research results, which also shows that after long-term follow-up, adverse reactions ( The incidence and severity of AE) did not change.
The most common treatment-related adverse reaction (TRAE) in the study was reactive capillary endothelial cell proliferation (86% in the combination therapy group vs.
84% in the monotherapy group); the second was leukopenia (62% vs.
32%).
Reactive capillary endothelial cell proliferation is a benign and reversible skin disease, which is related to carrelizumab.
The incidence of grade 3 or above AEs was 21% in the combined treatment group and 16% in the single-agent treatment group.
There were no fatal AEs.
In general, after a long-term follow-up of patients, decitabine + carrelizumab is well tolerated, and it is better than carrelizumab in patients with relapsed/refractory cHL.
Improved clinical outcome.
The advantages of decitabine combined with carrelizumab are significant in a wide range of cHL patients, especially for patients with large tumor burden and patients who have progressed after ASCT or are not suitable for ASCT.
At the 2021 Biopharmaceutical Innovation Technology Conference (BPIT) held by Yimike this month, Professor Han Weidong visited the conference site in person to explain to the audience the application of decitabine-treated CAR-T therapy in lymphoma and demonstrated this Excellent clinical performance of innovative therapies.
As a cutting-edge biomedical industry media, Emic has always focused on breakthroughs in new technologies and promoted clinical transformation of technologies through industrial integration.
The NADD Forum 2021 nucleic acid drug development forum will kick off on May 7-8, 2021 at Hualuxe and Yiheng Hotel in Nanjing Yangtze River Boat! Nucleic acid drugs as super drugs will lead innovative drugs into a new era! Who will be the proud son of the next era, we will jointly foresee with you in Nanjing.
Yimai Meng broke the news.
NK cell therapy of placenta origin, allogeneic and natural killer won the FDA orphan drug title for the treatment of glioblastoma Yimai Meng broke the news in 2021 April 17 / eMedClub News/--Classic Hodgkin's Lymphoma (cHL) is one of the most common malignant tumors in young people, so it has attracted more and more attention from the medical community and society.
Patients with relapsed/refractory cHL (R/R cHL) usually receive high-dose chemotherapy combined with autologous hematopoietic stem cell transplantation (ASCT), but the recurrence rate is high, the overall survival time is short, and there are serious treatment-related toxic and side effects.
Programmed death receptor 1 (PD-1) monotherapy has shown outstanding therapeutic effects in R/R cHL, but many patients will develop resistance to PD-1 inhibitors, and only some patients can achieve lasting remission .
Therefore, exploring new R/R cHL treatment options has important clinical significance.
Recently (April 5, 2021), the Journal for ImmunoTherapy of Cancer (JITC) published online a clinical research paper by Professor Han Weidong’s team at the PLA General Hospital, entitled "Improved clinical outcome in a randomized phase II study" of anti-PD-1 camrelizumab plus decitabine in relapsed/refractory Hodgkin lymphoma".
The study showed that in patients with R/R cHL, decitabine combined with the anti-PD-1 drug carrelizumab, compared with carrelizumab monotherapy, had a significant progression-free survival (PFS) extend.
Decitabine, as an epigenetic modifier, can reduce DNA methylation by inhibiting DNA methyltransferase.
Previously, Professor Han Weidong’s team found that low-dose decitabine can enhance T cell activity and improve the level of T cell exhaustion (Reference 3).
The combined use of Decitabine and PD-1 antibody has a synergistic effect and can improve the body's immune surveillance performance against tumors.
In 2019, the team published an article in the Journal of Clinical Oncology reporting the clinical efficacy of decitabine and PD1 antibody in combination with sensitization and potentiation of PD1 antibody in cHL (Reference 4).
In March of this year, further follow-up data from clinical trials were published in the Journal of Clinical Cancer Research, indicating that this combination therapy can achieve high remission rates and long-term benefits (Reference 2).
The study published on JITC included 61 patients with R/R cHL who were enrolled in a multi-center, phase 2 clinical trial (NCT02961101; NCT03250962) from January 2017 to July 2018.
These patients have failed second-line and above treatment options and have not received anti-PD-1 drug therapy in the past.
Patients were randomly assigned at a ratio of 1:2 and received carrelizumab (200 mg) monotherapy, or decitabine (10 mg/day, days 1-5) + carrelizumab ( 200mg, 8th day) combined treatment, every 3 weeks course of treatment.
▲ Study design (Image source: JITC) The median follow-up time of the study was 34.
5 months.
At the last follow-up, the complete response rate (CR) of the decitabine + carrelizumab combination treatment group was 79%, and the overall response rate (ORR) was 95%; the carrelizumab monotherapy group had CR Is 32% and ORR is 89%.
It is important that after long-term treatment, another patient in the decitabine + carrelizumab group achieved CR, and two of them achieved CR in the second year of the combined treatment.
Therefore, this report The data is higher than the previous study (Reference 4).
In the study, the median duration of response (DOR) was not reached in the combined treatment group, and the median DOR in the monotherapy group was 12.
7 months.
The proportion of patients in the combination therapy group who were still in remission at 2 years was 63%; in the monotherapy group, it was 35%.
▲DOR of CR and PR patients (picture source: JITC) The median progression-free survival (PFS) of the combined treatment group was 35 months, and that of the monotherapy group was 15.
5 months; the 2-year PFS rates of the two groups were 67 % And 42% (combination therapy group vs.
monotherapy group).
In most demographic and clinical subgroups, the PFS benefit observed with combination therapy is better than that of monotherapy, especially for patients with larger tumor burden and previous multiple-line therapy, in PD-1 therapy Adding decitabine can solve the urgent treatment needs of this population.
▲ In addition to the PFS of all 61 patients (picture source: JITC), the study also observed that with decitabine combined treatment, the percentage of circulating peripheral central memory T cells (Tcm) increased significantly, suggesting that this indicator is clinically relevant There is a direct correlation between remission and PFS, and it is expected to be an effective functional biomarker for predicting clinical remission and prognosis after decitabine+calorie combination therapy.
▲ Percentage of circulating peripheral central memory T cells (picture source: JITC) The safety characteristics of decitabine + carrelizumab are consistent with the team’s previous research results, which also shows that after long-term follow-up, adverse reactions ( The incidence and severity of AE) did not change.
The most common treatment-related adverse reaction (TRAE) in the study was reactive capillary endothelial cell proliferation (86% in the combination therapy group vs.
84% in the monotherapy group); the second was leukopenia (62% vs.
32%).
Reactive capillary endothelial cell proliferation is a benign and reversible skin disease, which is related to carrelizumab.
The incidence of grade 3 or above AEs was 21% in the combined treatment group and 16% in the single-agent treatment group.
There were no fatal AEs.
In general, after a long-term follow-up of patients, decitabine + carrelizumab is well tolerated, and it is better than carrelizumab in patients with relapsed/refractory cHL.
Improved clinical outcome.
The advantages of decitabine combined with carrelizumab are significant in a wide range of cHL patients, especially for patients with large tumor burden and patients who have progressed after ASCT or are not suitable for ASCT.
At the 2021 Biopharmaceutical Innovation Technology Conference (BPIT) held by Yimike this month, Professor Han Weidong visited the conference site in person to explain to the audience the application of decitabine-treated CAR-T therapy in lymphoma and demonstrated this Excellent clinical performance of innovative therapies.
As a cutting-edge biomedical industry media, Emic has always focused on breakthroughs in new technologies and promoted clinical transformation of technologies through industrial integration.
The NADD Forum 2021 nucleic acid drug development forum will kick off on May 7-8, 2021 at Hualuxe and Yiheng Hotel in Nanjing Yangtze River Boat! Nucleic acid drugs as super drugs will lead innovative drugs into a new era! Who will be the proud son of the next era, we will jointly foresee with you in Nanjing.
