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Pembrolizumab (PEM) has been approved by the US Food and Drug Administration (FDA) for the treatment of relapsed/refractory classic Hodgkin lymphoma (R/R cHL).
However, its efficacy in newly diagnosed cHL patients is still unknown.
Professor Pamela B.
Allen and others carried out a multi-center, single-arm, phase II clinical study to evaluate the short-term sequential AVD (doxorubicin, vinblastine, and dacarbazine) in the early stage of PEM monotherapy.
Prognostic factors and efficacy and safety in newly diagnosed cHL patients in advanced stage.
The preliminary analysis results of the study reported at the 2019 ASH Annual Meeting showed that after patients received PEM and sequential 2-cycle AVD treatment, the complete metabolic remission (CMR) rate according to mid-term PET-CT assessment reached 100%.
Recently, the final results of its related research have been announced, and the editor has compiled its main contents as follows for the reference of readers.
Research Method The NU16H08 trial is a multi-center, single-arm, phase II clinical study initiated by investigators to evaluate the efficacy and safety of sequential AVD chemotherapy after PEM monotherapy in the treatment of newly diagnosed cHL patients.
The patients included in the study were ≥18 years of age and newly diagnosed cHL, including early patients (according to NCCN criteria) and advanced patients with at least one adverse prognostic factor.
All patients received 3 cycles of PEM in order (a single dose of 200 mg, once every 3 weeks is a treatment cycle), and after the end of the PEM treatment, they received mid-term PET-CT (PET2) to evaluate the efficacy.
Subsequently, the patient received 4-6 cycles of AVD chemotherapy, and after 2 cycles of AVD chemotherapy, a mid-term PET-CT (PET3) examination was performed to evaluate the efficacy.
In addition, the patient needs to repeat PET-CT (PET4) examination at the end of the entire treatment to evaluate the efficacy.
According to the Lugano efficacy evaluation criteria and the total tumor metabolic volume (TMV) decline, the efficacy of PEM monotherapy was evaluated.
The study recommends but mandates that patients who are PET3 positive after 2 cycles of AVD chemotherapy should be replaced with dose-escalated BEACOPP regimens (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, carbachol and Prednisone) continue treatment.
Study results From September 2017 to March 2019, a total of 30 patients were enrolled.
The median age of the enrolled patients was 30 years old (range: 21-77 years old), and 4 patients were older than 60 years old.
Eleven patients were male, and most patients (83%) were white.
Twelve patients had early-stage prognostic diseases (6 patients had higher erythrocyte sedimentation rate [ESR], B symptoms, and large mediastinal masses).
18 patients had advanced disease (5 in stage III, 13 in stage IV; International Prognostic Score System-IPS score: 7 patients with a score of 3-4 and 10 patients with a score of 1-2).
Adverse risk factors for all patients (30 cases) included large masses or mediastinal masses (n=12), B symptoms (n=14), and extranodal diseases (n=16).
All patients in the study completed the planned treatment, including PEM monotherapy and AVD chemotherapy, and were followed up.
Eight early patients received four cycles of AVD treatment, and four of them had large mass disease at baseline.
The remaining 22 patients received 6 cycles of AVD treatment.
The overall treatment tolerance of the patients was good, and most of the adverse events (AE) were grade 1-2, of which 8 patients had grade 3-4 AEs and no grade 5 AEs were observed.
Grade 3-4 AEs related to PEM treatment include 1 case of immune-related transaminase elevation after the first AVD chemotherapy, 3 cases of grade 4 neutropenia, 1 case of grade 3 lymphopenia, and 1 case of grade 3 Diarrhea and 1 case of Grade 3 Bell's palsy.
At the end of PEM monotherapy, the patient’s CMR rate was 37% (11/30), of which the PET-CT Deauville 5-point method (D5-PS) was 1 point (n=2), 2 points (n=2) Or 3 points (n=7); in addition, 7/28 patients (25%) showed a TMV decrease of >90% in PET2.
All patients (n=30; 100%) achieved CMR after 2 cycles of AVD chemotherapy, and the CMR rate of patients at the end of treatment (EOT) was still 100%.
The median follow-up time from the patient's entry into the study was 22.
5 months (range 14.
2-30.
6 months), and the median follow-up time from the last treatment was 15.
4 months (range 6.
6-24.
9 months).
No patient progressed, died or received follow-up treatment.
The patient's median progression-free survival (PFS) and overall survival (OS) were not reached.
As of this analysis, the patients' PFS rate and OS rate were both 100%.
Research conclusions The study shows that in newly diagnosed cHL patients with poor early prognosis and advanced stage (including large mass disease), the AVD regimen after PEM monotherapy for a short period of time has amazing efficacy and good safety.
References: Pamela B Allen, Hatice Savas, Andrew M Evens, et al.
Pembrolizumab followed by AVD in untreated early unfavorable and advanced-stage classical Hodgkin lymphoma.
Blood.
2021 Mar 11;137(10):1318-1326.
Poke” Read the original ", we make progress together
However, its efficacy in newly diagnosed cHL patients is still unknown.
Professor Pamela B.
Allen and others carried out a multi-center, single-arm, phase II clinical study to evaluate the short-term sequential AVD (doxorubicin, vinblastine, and dacarbazine) in the early stage of PEM monotherapy.
Prognostic factors and efficacy and safety in newly diagnosed cHL patients in advanced stage.
The preliminary analysis results of the study reported at the 2019 ASH Annual Meeting showed that after patients received PEM and sequential 2-cycle AVD treatment, the complete metabolic remission (CMR) rate according to mid-term PET-CT assessment reached 100%.
Recently, the final results of its related research have been announced, and the editor has compiled its main contents as follows for the reference of readers.
Research Method The NU16H08 trial is a multi-center, single-arm, phase II clinical study initiated by investigators to evaluate the efficacy and safety of sequential AVD chemotherapy after PEM monotherapy in the treatment of newly diagnosed cHL patients.
The patients included in the study were ≥18 years of age and newly diagnosed cHL, including early patients (according to NCCN criteria) and advanced patients with at least one adverse prognostic factor.
All patients received 3 cycles of PEM in order (a single dose of 200 mg, once every 3 weeks is a treatment cycle), and after the end of the PEM treatment, they received mid-term PET-CT (PET2) to evaluate the efficacy.
Subsequently, the patient received 4-6 cycles of AVD chemotherapy, and after 2 cycles of AVD chemotherapy, a mid-term PET-CT (PET3) examination was performed to evaluate the efficacy.
In addition, the patient needs to repeat PET-CT (PET4) examination at the end of the entire treatment to evaluate the efficacy.
According to the Lugano efficacy evaluation criteria and the total tumor metabolic volume (TMV) decline, the efficacy of PEM monotherapy was evaluated.
The study recommends but mandates that patients who are PET3 positive after 2 cycles of AVD chemotherapy should be replaced with dose-escalated BEACOPP regimens (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, carbachol and Prednisone) continue treatment.
Study results From September 2017 to March 2019, a total of 30 patients were enrolled.
The median age of the enrolled patients was 30 years old (range: 21-77 years old), and 4 patients were older than 60 years old.
Eleven patients were male, and most patients (83%) were white.
Twelve patients had early-stage prognostic diseases (6 patients had higher erythrocyte sedimentation rate [ESR], B symptoms, and large mediastinal masses).
18 patients had advanced disease (5 in stage III, 13 in stage IV; International Prognostic Score System-IPS score: 7 patients with a score of 3-4 and 10 patients with a score of 1-2).
Adverse risk factors for all patients (30 cases) included large masses or mediastinal masses (n=12), B symptoms (n=14), and extranodal diseases (n=16).
All patients in the study completed the planned treatment, including PEM monotherapy and AVD chemotherapy, and were followed up.
Eight early patients received four cycles of AVD treatment, and four of them had large mass disease at baseline.
The remaining 22 patients received 6 cycles of AVD treatment.
The overall treatment tolerance of the patients was good, and most of the adverse events (AE) were grade 1-2, of which 8 patients had grade 3-4 AEs and no grade 5 AEs were observed.
Grade 3-4 AEs related to PEM treatment include 1 case of immune-related transaminase elevation after the first AVD chemotherapy, 3 cases of grade 4 neutropenia, 1 case of grade 3 lymphopenia, and 1 case of grade 3 Diarrhea and 1 case of Grade 3 Bell's palsy.
At the end of PEM monotherapy, the patient’s CMR rate was 37% (11/30), of which the PET-CT Deauville 5-point method (D5-PS) was 1 point (n=2), 2 points (n=2) Or 3 points (n=7); in addition, 7/28 patients (25%) showed a TMV decrease of >90% in PET2.
All patients (n=30; 100%) achieved CMR after 2 cycles of AVD chemotherapy, and the CMR rate of patients at the end of treatment (EOT) was still 100%.
The median follow-up time from the patient's entry into the study was 22.
5 months (range 14.
2-30.
6 months), and the median follow-up time from the last treatment was 15.
4 months (range 6.
6-24.
9 months).
No patient progressed, died or received follow-up treatment.
The patient's median progression-free survival (PFS) and overall survival (OS) were not reached.
As of this analysis, the patients' PFS rate and OS rate were both 100%.
Research conclusions The study shows that in newly diagnosed cHL patients with poor early prognosis and advanced stage (including large mass disease), the AVD regimen after PEM monotherapy for a short period of time has amazing efficacy and good safety.
References: Pamela B Allen, Hatice Savas, Andrew M Evens, et al.
Pembrolizumab followed by AVD in untreated early unfavorable and advanced-stage classical Hodgkin lymphoma.
Blood.
2021 Mar 11;137(10):1318-1326.
Poke” Read the original ", we make progress together
