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Migraine: CGRP-mAb class switch beneficial among nonresponders or those experiencing gradual loss of efficacy
Key clinical point: Switching calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) may benefit patients with episodic migraine (EM) or chronic migraine (CM) who had failed to respond to the first CGRP-mAb or experienced a loss of efficacy over time.
Major finding: Overall, 71.9% of patients responded to the first CGRP-mAb, 42.3% of those who did not respond or experienced a loss of efficacy over time to the first CGRP-mAb responded to the second CGRP-mAb, and 28.6% of patients who received the third CGRP-mAb showed a response.
Study details: Findings are from a retrospective, real-world case series including 171 patients with EM or CM who received one (n = 137), two (n = 27), or all three(n = 7) CGRP-mAb as migraine preventive therapy.
Disclosures: This study received no specific funding from any source. Some authors declared receiving personal fees, unrestricted grants, honoraria, or travel grants from various sources.
Source: Kaltseis K et al. Monoclonal antibodies against CGRP (R): Non-responders and switchers: Real world data from an Austrian case series. BMC Neurol. 2023;23(1):174 (Apr 28). doi: 10.1186/s12883-023-03203-9
Key clinical point: Switching calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) may benefit patients with episodic migraine (EM) or chronic migraine (CM) who had failed to respond to the first CGRP-mAb or experienced a loss of efficacy over time.
Major finding: Overall, 71.9% of patients responded to the first CGRP-mAb, 42.3% of those who did not respond or experienced a loss of efficacy over time to the first CGRP-mAb responded to the second CGRP-mAb, and 28.6% of patients who received the third CGRP-mAb showed a response.
Study details: Findings are from a retrospective, real-world case series including 171 patients with EM or CM who received one (n = 137), two (n = 27), or all three(n = 7) CGRP-mAb as migraine preventive therapy.
Disclosures: This study received no specific funding from any source. Some authors declared receiving personal fees, unrestricted grants, honoraria, or travel grants from various sources.
Source: Kaltseis K et al. Monoclonal antibodies against CGRP (R): Non-responders and switchers: Real world data from an Austrian case series. BMC Neurol. 2023;23(1):174 (Apr 28). doi: 10.1186/s12883-023-03203-9
Key clinical point: Switching calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) may benefit patients with episodic migraine (EM) or chronic migraine (CM) who had failed to respond to the first CGRP-mAb or experienced a loss of efficacy over time.
Major finding: Overall, 71.9% of patients responded to the first CGRP-mAb, 42.3% of those who did not respond or experienced a loss of efficacy over time to the first CGRP-mAb responded to the second CGRP-mAb, and 28.6% of patients who received the third CGRP-mAb showed a response.
Study details: Findings are from a retrospective, real-world case series including 171 patients with EM or CM who received one (n = 137), two (n = 27), or all three(n = 7) CGRP-mAb as migraine preventive therapy.
Disclosures: This study received no specific funding from any source. Some authors declared receiving personal fees, unrestricted grants, honoraria, or travel grants from various sources.
Source: Kaltseis K et al. Monoclonal antibodies against CGRP (R): Non-responders and switchers: Real world data from an Austrian case series. BMC Neurol. 2023;23(1):174 (Apr 28). doi: 10.1186/s12883-023-03203-9
Galcanezumab shows sustained response in episodic, chronic, and treatment-resistant migraine
Key clinical point: A higher proportion of patients with episodic migraine (EM), chronic migraine (CM), or treatment-resistant migraine receiving galcanezumab vs placebo achieved a ≥50% response within the first 3 months of treatment, which was sustained for 4-6 months.
Major finding: Galcanezumab vs placebo was associated with higher odds of clinical response in patients with EM (120 mg galcanezumab: odds ratio [OR] 2.7) and CM (120 mg galcanezumab: OR 19.4; all P < .001), with a higher proportion of galcanezumab- vs placebo-treated patients maintaining ≥50% response for 3-6 months of the double-blind treatment period (P < .001).
Study details: This post hoc analysis included 3348 patients with EM (EVOLVE-1 and EVOLVE-2 trials), CM (REGAIN trial), or EM or CM with 2-4 prior treatment failures (CONQUER trial) who received galcanezumab or placebo.
Disclosures: This study was funded by Eli Lilly and Company or one of its subsidiaries, Indianapolis, IN, USA. Three authors declared being employees of Eli Lilly. SJ Tepper declared ties with various sources, including Eli Lilly.
Source: Tepper SJ et al. Sustained response of galcanezumab in migraine prevention: Patient-level data from a post hoc analysis in patients with episodic or chronic migraine. Headache. 2023 (May 3). doi: 10.1111/head.14494
Key clinical point: A higher proportion of patients with episodic migraine (EM), chronic migraine (CM), or treatment-resistant migraine receiving galcanezumab vs placebo achieved a ≥50% response within the first 3 months of treatment, which was sustained for 4-6 months.
Major finding: Galcanezumab vs placebo was associated with higher odds of clinical response in patients with EM (120 mg galcanezumab: odds ratio [OR] 2.7) and CM (120 mg galcanezumab: OR 19.4; all P < .001), with a higher proportion of galcanezumab- vs placebo-treated patients maintaining ≥50% response for 3-6 months of the double-blind treatment period (P < .001).
Study details: This post hoc analysis included 3348 patients with EM (EVOLVE-1 and EVOLVE-2 trials), CM (REGAIN trial), or EM or CM with 2-4 prior treatment failures (CONQUER trial) who received galcanezumab or placebo.
Disclosures: This study was funded by Eli Lilly and Company or one of its subsidiaries, Indianapolis, IN, USA. Three authors declared being employees of Eli Lilly. SJ Tepper declared ties with various sources, including Eli Lilly.
Source: Tepper SJ et al. Sustained response of galcanezumab in migraine prevention: Patient-level data from a post hoc analysis in patients with episodic or chronic migraine. Headache. 2023 (May 3). doi: 10.1111/head.14494
Key clinical point: A higher proportion of patients with episodic migraine (EM), chronic migraine (CM), or treatment-resistant migraine receiving galcanezumab vs placebo achieved a ≥50% response within the first 3 months of treatment, which was sustained for 4-6 months.
Major finding: Galcanezumab vs placebo was associated with higher odds of clinical response in patients with EM (120 mg galcanezumab: odds ratio [OR] 2.7) and CM (120 mg galcanezumab: OR 19.4; all P < .001), with a higher proportion of galcanezumab- vs placebo-treated patients maintaining ≥50% response for 3-6 months of the double-blind treatment period (P < .001).
Study details: This post hoc analysis included 3348 patients with EM (EVOLVE-1 and EVOLVE-2 trials), CM (REGAIN trial), or EM or CM with 2-4 prior treatment failures (CONQUER trial) who received galcanezumab or placebo.
Disclosures: This study was funded by Eli Lilly and Company or one of its subsidiaries, Indianapolis, IN, USA. Three authors declared being employees of Eli Lilly. SJ Tepper declared ties with various sources, including Eli Lilly.
Source: Tepper SJ et al. Sustained response of galcanezumab in migraine prevention: Patient-level data from a post hoc analysis in patients with episodic or chronic migraine. Headache. 2023 (May 3). doi: 10.1111/head.14494
Eptinezumab lowers monthly migraine days in patients with multiple treatment failures
Key clinical point: Eptinezumab led to significantly greater reductions in monthly migraine days (MMD) in patients with migraine who previously failed multiple migraine preventive treatments.
Major finding: Reduction in monthly migraine days over 1-12 weeks was significantly higher with 100 mg eptinezumab (−4.8 days) and 300 mg eptinezumab (−5.3 days) vs placebo (−2.1 days; both P < .0001), with reductions sustained or improved over 13-24 weeks and the odds of achieving ≥50% and ≥75% reduction in MMD favoring eptinezumab over placebo (P < .05).
Study details: This subgroup analysis of the DELIVER trial included 299, 293, and 298 patients with migraine and multiple unsuccessful treatments who were randomly assigned to receive 100 mg eptinezumab, 300 mg eptinezumab, and placebo, respectively.
Disclosures: This study was funded by H. Lundbeck A/S. Some authors declared receiving personal fees or honoraria or serving as consultants or on advisory board for various sources. The other authors declared being full-time employees of H. Lundbeck A/S or one of its subsidiary companies.
Source: Ashina M et al. Efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures: Subgroup analysis of the randomized, placebo-controlled DELIVER study. Cephalalgia. 2023 (Apr 26). doi: 10.1177/03331024231170807
Key clinical point: Eptinezumab led to significantly greater reductions in monthly migraine days (MMD) in patients with migraine who previously failed multiple migraine preventive treatments.
Major finding: Reduction in monthly migraine days over 1-12 weeks was significantly higher with 100 mg eptinezumab (−4.8 days) and 300 mg eptinezumab (−5.3 days) vs placebo (−2.1 days; both P < .0001), with reductions sustained or improved over 13-24 weeks and the odds of achieving ≥50% and ≥75% reduction in MMD favoring eptinezumab over placebo (P < .05).
Study details: This subgroup analysis of the DELIVER trial included 299, 293, and 298 patients with migraine and multiple unsuccessful treatments who were randomly assigned to receive 100 mg eptinezumab, 300 mg eptinezumab, and placebo, respectively.
Disclosures: This study was funded by H. Lundbeck A/S. Some authors declared receiving personal fees or honoraria or serving as consultants or on advisory board for various sources. The other authors declared being full-time employees of H. Lundbeck A/S or one of its subsidiary companies.
Source: Ashina M et al. Efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures: Subgroup analysis of the randomized, placebo-controlled DELIVER study. Cephalalgia. 2023 (Apr 26). doi: 10.1177/03331024231170807
Key clinical point: Eptinezumab led to significantly greater reductions in monthly migraine days (MMD) in patients with migraine who previously failed multiple migraine preventive treatments.
Major finding: Reduction in monthly migraine days over 1-12 weeks was significantly higher with 100 mg eptinezumab (−4.8 days) and 300 mg eptinezumab (−5.3 days) vs placebo (−2.1 days; both P < .0001), with reductions sustained or improved over 13-24 weeks and the odds of achieving ≥50% and ≥75% reduction in MMD favoring eptinezumab over placebo (P < .05).
Study details: This subgroup analysis of the DELIVER trial included 299, 293, and 298 patients with migraine and multiple unsuccessful treatments who were randomly assigned to receive 100 mg eptinezumab, 300 mg eptinezumab, and placebo, respectively.
Disclosures: This study was funded by H. Lundbeck A/S. Some authors declared receiving personal fees or honoraria or serving as consultants or on advisory board for various sources. The other authors declared being full-time employees of H. Lundbeck A/S or one of its subsidiary companies.
Source: Ashina M et al. Efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures: Subgroup analysis of the randomized, placebo-controlled DELIVER study. Cephalalgia. 2023 (Apr 26). doi: 10.1177/03331024231170807
Late response to CGRP monoclonal antibodies is frequent in migraine
Key clinical point: Half of the patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who did not respond to anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) at 12 weeks were indeed late responders, suggesting the need for extension of treatment duration beyond 12 months.
Major finding: At 12 weeks, 34.4% were nonresponders, of which 55.1% showed response between 13 and 24 weeks and were classified as late responders. Compared with responders, late responders had a higher body mass index (P = .024), more frequent prior treatment failures (P = .017), and psychiatric comorbidities (P = .041).
Study details: This was a prospective, real-life study including 771 patients with HFEM or CM who received anti-CGRP mAb for ≥24 weeks.
Disclosures: This study was partially supported by the Italian Ministry of Health, IRCCS San Raffaele Roma, and Fondazione Italiana Cefalee. Some authors declared receiving travel grants or honoraria for advisory board participations or serving on speaker panels or clinical investigation studies for various sources.
Source: Barbanti P et al for the Italian Migraine Registry study group. Late response to anti-CGRP monoclonal antibodies in migraine: A multicenter, prospective, observational study. Neurology. 2023 (Apr 18). doi: 10.1212/WNL.0000000000207292
Key clinical point: Half of the patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who did not respond to anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) at 12 weeks were indeed late responders, suggesting the need for extension of treatment duration beyond 12 months.
Major finding: At 12 weeks, 34.4% were nonresponders, of which 55.1% showed response between 13 and 24 weeks and were classified as late responders. Compared with responders, late responders had a higher body mass index (P = .024), more frequent prior treatment failures (P = .017), and psychiatric comorbidities (P = .041).
Study details: This was a prospective, real-life study including 771 patients with HFEM or CM who received anti-CGRP mAb for ≥24 weeks.
Disclosures: This study was partially supported by the Italian Ministry of Health, IRCCS San Raffaele Roma, and Fondazione Italiana Cefalee. Some authors declared receiving travel grants or honoraria for advisory board participations or serving on speaker panels or clinical investigation studies for various sources.
Source: Barbanti P et al for the Italian Migraine Registry study group. Late response to anti-CGRP monoclonal antibodies in migraine: A multicenter, prospective, observational study. Neurology. 2023 (Apr 18). doi: 10.1212/WNL.0000000000207292
Key clinical point: Half of the patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who did not respond to anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAb) at 12 weeks were indeed late responders, suggesting the need for extension of treatment duration beyond 12 months.
Major finding: At 12 weeks, 34.4% were nonresponders, of which 55.1% showed response between 13 and 24 weeks and were classified as late responders. Compared with responders, late responders had a higher body mass index (P = .024), more frequent prior treatment failures (P = .017), and psychiatric comorbidities (P = .041).
Study details: This was a prospective, real-life study including 771 patients with HFEM or CM who received anti-CGRP mAb for ≥24 weeks.
Disclosures: This study was partially supported by the Italian Ministry of Health, IRCCS San Raffaele Roma, and Fondazione Italiana Cefalee. Some authors declared receiving travel grants or honoraria for advisory board participations or serving on speaker panels or clinical investigation studies for various sources.
Source: Barbanti P et al for the Italian Migraine Registry study group. Late response to anti-CGRP monoclonal antibodies in migraine: A multicenter, prospective, observational study. Neurology. 2023 (Apr 18). doi: 10.1212/WNL.0000000000207292
Long-term follow-up confirms sustained efficacy of pembrolizumab in heavily pretreated PMBCL
Key clinical point: Pembrolizumab offers potent and sustained efficacy with an acceptable safety profile in heavily pretreated patients with relapsed or refractory primary mediastinal B-cell lymphoma (PMBCL).
Major finding: After a median follow-up of 48.7 months, the median progression-free survival and overall survival were 4.3 (95% CI 2.8-13.8) months and 22.3 (95% CI 7.3-not reached) months, respectively. The objective response rate was 41.5%. Grade 3 or 4 treatment-related adverse events occurred in 22.6% of patients.
Study details: Findings are from the final analysis of the phase 2 KEYNOTE-170 trial including 53 adult patients with relapsed or refractory PMBCL whose disease progressed after or who were ineligible for (after ≥2 prior lines of therapy) autologous stem cell transplantation and received pembrolizumab every 3 weeks for up to 2 years.
Disclosures: The KEYNOTE-170 trial was funded by Merck Sharp & Dohme (MSD). Some authors reported ties with various organizations, including MSD. Three authors declared being employees of and holding stock or stock options in MSD.
Source: Zinzani PL et al. Pembrolizumab in relapsed or refractory primary mediastinal large B-cell lymphoma: Final analysis of KEYNOTE-170. Blood. 2023 (May 2). Doi: 10.1182/blood.2022019340
Key clinical point: Pembrolizumab offers potent and sustained efficacy with an acceptable safety profile in heavily pretreated patients with relapsed or refractory primary mediastinal B-cell lymphoma (PMBCL).
Major finding: After a median follow-up of 48.7 months, the median progression-free survival and overall survival were 4.3 (95% CI 2.8-13.8) months and 22.3 (95% CI 7.3-not reached) months, respectively. The objective response rate was 41.5%. Grade 3 or 4 treatment-related adverse events occurred in 22.6% of patients.
Study details: Findings are from the final analysis of the phase 2 KEYNOTE-170 trial including 53 adult patients with relapsed or refractory PMBCL whose disease progressed after or who were ineligible for (after ≥2 prior lines of therapy) autologous stem cell transplantation and received pembrolizumab every 3 weeks for up to 2 years.
Disclosures: The KEYNOTE-170 trial was funded by Merck Sharp & Dohme (MSD). Some authors reported ties with various organizations, including MSD. Three authors declared being employees of and holding stock or stock options in MSD.
Source: Zinzani PL et al. Pembrolizumab in relapsed or refractory primary mediastinal large B-cell lymphoma: Final analysis of KEYNOTE-170. Blood. 2023 (May 2). Doi: 10.1182/blood.2022019340
Key clinical point: Pembrolizumab offers potent and sustained efficacy with an acceptable safety profile in heavily pretreated patients with relapsed or refractory primary mediastinal B-cell lymphoma (PMBCL).
Major finding: After a median follow-up of 48.7 months, the median progression-free survival and overall survival were 4.3 (95% CI 2.8-13.8) months and 22.3 (95% CI 7.3-not reached) months, respectively. The objective response rate was 41.5%. Grade 3 or 4 treatment-related adverse events occurred in 22.6% of patients.
Study details: Findings are from the final analysis of the phase 2 KEYNOTE-170 trial including 53 adult patients with relapsed or refractory PMBCL whose disease progressed after or who were ineligible for (after ≥2 prior lines of therapy) autologous stem cell transplantation and received pembrolizumab every 3 weeks for up to 2 years.
Disclosures: The KEYNOTE-170 trial was funded by Merck Sharp & Dohme (MSD). Some authors reported ties with various organizations, including MSD. Three authors declared being employees of and holding stock or stock options in MSD.
Source: Zinzani PL et al. Pembrolizumab in relapsed or refractory primary mediastinal large B-cell lymphoma: Final analysis of KEYNOTE-170. Blood. 2023 (May 2). Doi: 10.1182/blood.2022019340
Survival outcomes after early termination of R-CHOP in diffuse large B-cell lymphoma
Key clinical point: Among patients with diffuse large B-cell lymphoma (DLBCL) who do not complete the recommended six cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) combination chemotherapy, those who do vs do not achieve primary response or complete ≥3 chemotherapy cycles have better survival.
Major finding: The 5-year overall survival rate was significantly higher in patients who did vs did not complete ≥3 cycles of R-CHOP (58.5% vs 24.2%; P < .001) and in those who did vs did not achieve complete or partial response after R-CHOP (56.9% vs 14.1%; P < .001).
Study details: Findings are from a single-center real-world retrospective study including 165 patients with DLBCL who did not receive the planned 6 cycles of R-CHOP.
Disclosures: No information on the source of funding was provided. SS Yoon declared serving as an advisor for and receiving research grants from various organizations.
Source: Yoon J et al. Clinical outcomes after incomplete cycles of R-CHOP for diffuse large B-cell lymphoma: 10 years' real-world experience in a single institute. Ann Hematol. 2023;102:1467-1476 (Apr 26). Doi: 10.1007/s00277-023-05179-5
Key clinical point: Among patients with diffuse large B-cell lymphoma (DLBCL) who do not complete the recommended six cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) combination chemotherapy, those who do vs do not achieve primary response or complete ≥3 chemotherapy cycles have better survival.
Major finding: The 5-year overall survival rate was significantly higher in patients who did vs did not complete ≥3 cycles of R-CHOP (58.5% vs 24.2%; P < .001) and in those who did vs did not achieve complete or partial response after R-CHOP (56.9% vs 14.1%; P < .001).
Study details: Findings are from a single-center real-world retrospective study including 165 patients with DLBCL who did not receive the planned 6 cycles of R-CHOP.
Disclosures: No information on the source of funding was provided. SS Yoon declared serving as an advisor for and receiving research grants from various organizations.
Source: Yoon J et al. Clinical outcomes after incomplete cycles of R-CHOP for diffuse large B-cell lymphoma: 10 years' real-world experience in a single institute. Ann Hematol. 2023;102:1467-1476 (Apr 26). Doi: 10.1007/s00277-023-05179-5
Key clinical point: Among patients with diffuse large B-cell lymphoma (DLBCL) who do not complete the recommended six cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) combination chemotherapy, those who do vs do not achieve primary response or complete ≥3 chemotherapy cycles have better survival.
Major finding: The 5-year overall survival rate was significantly higher in patients who did vs did not complete ≥3 cycles of R-CHOP (58.5% vs 24.2%; P < .001) and in those who did vs did not achieve complete or partial response after R-CHOP (56.9% vs 14.1%; P < .001).
Study details: Findings are from a single-center real-world retrospective study including 165 patients with DLBCL who did not receive the planned 6 cycles of R-CHOP.
Disclosures: No information on the source of funding was provided. SS Yoon declared serving as an advisor for and receiving research grants from various organizations.
Source: Yoon J et al. Clinical outcomes after incomplete cycles of R-CHOP for diffuse large B-cell lymphoma: 10 years' real-world experience in a single institute. Ann Hematol. 2023;102:1467-1476 (Apr 26). Doi: 10.1007/s00277-023-05179-5
Orelabrutinib offers a promising treatment option for relapsed or refractory MCL
Key clinical point: Orelabrutinib showed considerable efficacy and a favorable safety profile in patients with relapsed or refractory mantle cell lymphoma (MCL).
Major finding: After a median follow-up of 23.8 months, the overall response rate was 81.1%, with 27.4% and 53.8% of patients achieving complete and partial responses, respectively. The median duration of response and progression-free survival were 22.9 (95% CI 16.4-not reached) and 22.0 (95% CI 13.8-not reached) months, respectively. The median overall survival was not reached. Most adverse events (AE) were grade 1 or 2. Grade ≥3 AE were infrequent, with thrombocytopenia (13.2%), neutropenia (8.5%), and anemia (7.5%) being the most common.
Study details: This multicenter phase 1/2 study included adult patients with MCL who had relapsed after or were refractory to ≥1 and ≤4 prior therapies and received 150 mg oral orelabrutinib once daily (n = 86) or 100 mg twice daily (n = 20).
Disclosures: This study was sponsored by InnoCare Pharma Limited, China. Four authors declared being employees of InnoCare. The other authors declared no financial conflicts of interest.
Source: Deng LJ et al. Orelabrutinib for the treatment of relapsed or refractory MCL: A phase 1/2, open-label, multicenter, single-arm study. Blood Adv. 2023 (Apr 20). Doi: 10.1182/bloodadvances.2022009168
Key clinical point: Orelabrutinib showed considerable efficacy and a favorable safety profile in patients with relapsed or refractory mantle cell lymphoma (MCL).
Major finding: After a median follow-up of 23.8 months, the overall response rate was 81.1%, with 27.4% and 53.8% of patients achieving complete and partial responses, respectively. The median duration of response and progression-free survival were 22.9 (95% CI 16.4-not reached) and 22.0 (95% CI 13.8-not reached) months, respectively. The median overall survival was not reached. Most adverse events (AE) were grade 1 or 2. Grade ≥3 AE were infrequent, with thrombocytopenia (13.2%), neutropenia (8.5%), and anemia (7.5%) being the most common.
Study details: This multicenter phase 1/2 study included adult patients with MCL who had relapsed after or were refractory to ≥1 and ≤4 prior therapies and received 150 mg oral orelabrutinib once daily (n = 86) or 100 mg twice daily (n = 20).
Disclosures: This study was sponsored by InnoCare Pharma Limited, China. Four authors declared being employees of InnoCare. The other authors declared no financial conflicts of interest.
Source: Deng LJ et al. Orelabrutinib for the treatment of relapsed or refractory MCL: A phase 1/2, open-label, multicenter, single-arm study. Blood Adv. 2023 (Apr 20). Doi: 10.1182/bloodadvances.2022009168
Key clinical point: Orelabrutinib showed considerable efficacy and a favorable safety profile in patients with relapsed or refractory mantle cell lymphoma (MCL).
Major finding: After a median follow-up of 23.8 months, the overall response rate was 81.1%, with 27.4% and 53.8% of patients achieving complete and partial responses, respectively. The median duration of response and progression-free survival were 22.9 (95% CI 16.4-not reached) and 22.0 (95% CI 13.8-not reached) months, respectively. The median overall survival was not reached. Most adverse events (AE) were grade 1 or 2. Grade ≥3 AE were infrequent, with thrombocytopenia (13.2%), neutropenia (8.5%), and anemia (7.5%) being the most common.
Study details: This multicenter phase 1/2 study included adult patients with MCL who had relapsed after or were refractory to ≥1 and ≤4 prior therapies and received 150 mg oral orelabrutinib once daily (n = 86) or 100 mg twice daily (n = 20).
Disclosures: This study was sponsored by InnoCare Pharma Limited, China. Four authors declared being employees of InnoCare. The other authors declared no financial conflicts of interest.
Source: Deng LJ et al. Orelabrutinib for the treatment of relapsed or refractory MCL: A phase 1/2, open-label, multicenter, single-arm study. Blood Adv. 2023 (Apr 20). Doi: 10.1182/bloodadvances.2022009168
First-line autologous stem cell transplantation provides sustained remission in disseminated MCL
Key clinical point: First-line autologous stem cell transplantation (ASCT) resulted in long-term clinical and molecular remissions in patients with disseminated mantle cell lymphoma (MCL).
Major finding: The 10-year overall survival, progression-free survival, and freedom from progression rates for the first-line vs second-line cohort were 64%, 52%, and 59% vs 50%, 20%, and 20%, respectively. Overall, 27 patients experienced sustained clinical remissions between 5 and 19 years, of which 26 were continuously minimal residual disease (MRD) negative based on all samples collected after ASCT.
Study details: The data come from a partly prospective and partly retrospective study including 65 patients with disseminated MCL who received high-dose therapy with ASCT as first- (n = 54), second- (n = 10), or third-line (n = 1) treatment.
Disclosures: The MRD analysis was partly funded by BMBF (The Federal Ministry of Education and Research, Germany). M Dreyling declared serving on the scientific advisory boards of and receiving research support and speaker honoraria from various organizations. Other authors declared no conflicts of interest.
Source: Metzner B et al. Long-term outcome in patients with mantle cell lymphoma following high-dose therapy and autologous stem cell transplantation. Eur J Haematol. 2023 (Apr 24). Doi: 10.1111/ejh.13985
Key clinical point: First-line autologous stem cell transplantation (ASCT) resulted in long-term clinical and molecular remissions in patients with disseminated mantle cell lymphoma (MCL).
Major finding: The 10-year overall survival, progression-free survival, and freedom from progression rates for the first-line vs second-line cohort were 64%, 52%, and 59% vs 50%, 20%, and 20%, respectively. Overall, 27 patients experienced sustained clinical remissions between 5 and 19 years, of which 26 were continuously minimal residual disease (MRD) negative based on all samples collected after ASCT.
Study details: The data come from a partly prospective and partly retrospective study including 65 patients with disseminated MCL who received high-dose therapy with ASCT as first- (n = 54), second- (n = 10), or third-line (n = 1) treatment.
Disclosures: The MRD analysis was partly funded by BMBF (The Federal Ministry of Education and Research, Germany). M Dreyling declared serving on the scientific advisory boards of and receiving research support and speaker honoraria from various organizations. Other authors declared no conflicts of interest.
Source: Metzner B et al. Long-term outcome in patients with mantle cell lymphoma following high-dose therapy and autologous stem cell transplantation. Eur J Haematol. 2023 (Apr 24). Doi: 10.1111/ejh.13985
Key clinical point: First-line autologous stem cell transplantation (ASCT) resulted in long-term clinical and molecular remissions in patients with disseminated mantle cell lymphoma (MCL).
Major finding: The 10-year overall survival, progression-free survival, and freedom from progression rates for the first-line vs second-line cohort were 64%, 52%, and 59% vs 50%, 20%, and 20%, respectively. Overall, 27 patients experienced sustained clinical remissions between 5 and 19 years, of which 26 were continuously minimal residual disease (MRD) negative based on all samples collected after ASCT.
Study details: The data come from a partly prospective and partly retrospective study including 65 patients with disseminated MCL who received high-dose therapy with ASCT as first- (n = 54), second- (n = 10), or third-line (n = 1) treatment.
Disclosures: The MRD analysis was partly funded by BMBF (The Federal Ministry of Education and Research, Germany). M Dreyling declared serving on the scientific advisory boards of and receiving research support and speaker honoraria from various organizations. Other authors declared no conflicts of interest.
Source: Metzner B et al. Long-term outcome in patients with mantle cell lymphoma following high-dose therapy and autologous stem cell transplantation. Eur J Haematol. 2023 (Apr 24). Doi: 10.1111/ejh.13985
Specific SNP may predict lenalidomide efficacy after autologous stem cell transplantation in MCL
Key clinical point: Single nucleotide polymorphisms (SNP) of genes encoding specific cellular proteins may be associated with clinical outcomes and represent predictive biomarkers of poor response to lenalidomide maintenance after autologous stem cell transplantation (ASCT) in mantle cell lymphoma (MCL).
Major finding: Patients with ABCB1 or VEGF polymorphisms vs homozygous wild type (WT) in the lenalidomide arm had significantly higher 3-year progression-free survival (PFS) rates (85% vs 70%; P = .047 and 85% vs 60%; P = .0021, respectively). Lenalidomide vs observation did not improve 3-year PFS rates in patients carrying both ABCB1 and VEGF WT (P = .632).
Study details: This pharmacogenetic study included 278 adult patients with previously untreated MCL and adequate biological samples from the phase 3 MCL0208 study, 197 of whom were genotyped after ASCT and randomly assigned to the lenalidomide maintenance or observation arm.
Disclosures: This study was funded by Cancer Research UK and others. Some authors reported ties with various organizations.
Source: Ferrero S et al. Candidate germline biomarkers of lenalidomide efficacy in mantle cell lymphoma: The FIL MCL0208 trial. Blood Adv. 2023 (Apr 14). Doi: 10.1182/bloodadvances.2022009504
Key clinical point: Single nucleotide polymorphisms (SNP) of genes encoding specific cellular proteins may be associated with clinical outcomes and represent predictive biomarkers of poor response to lenalidomide maintenance after autologous stem cell transplantation (ASCT) in mantle cell lymphoma (MCL).
Major finding: Patients with ABCB1 or VEGF polymorphisms vs homozygous wild type (WT) in the lenalidomide arm had significantly higher 3-year progression-free survival (PFS) rates (85% vs 70%; P = .047 and 85% vs 60%; P = .0021, respectively). Lenalidomide vs observation did not improve 3-year PFS rates in patients carrying both ABCB1 and VEGF WT (P = .632).
Study details: This pharmacogenetic study included 278 adult patients with previously untreated MCL and adequate biological samples from the phase 3 MCL0208 study, 197 of whom were genotyped after ASCT and randomly assigned to the lenalidomide maintenance or observation arm.
Disclosures: This study was funded by Cancer Research UK and others. Some authors reported ties with various organizations.
Source: Ferrero S et al. Candidate germline biomarkers of lenalidomide efficacy in mantle cell lymphoma: The FIL MCL0208 trial. Blood Adv. 2023 (Apr 14). Doi: 10.1182/bloodadvances.2022009504
Key clinical point: Single nucleotide polymorphisms (SNP) of genes encoding specific cellular proteins may be associated with clinical outcomes and represent predictive biomarkers of poor response to lenalidomide maintenance after autologous stem cell transplantation (ASCT) in mantle cell lymphoma (MCL).
Major finding: Patients with ABCB1 or VEGF polymorphisms vs homozygous wild type (WT) in the lenalidomide arm had significantly higher 3-year progression-free survival (PFS) rates (85% vs 70%; P = .047 and 85% vs 60%; P = .0021, respectively). Lenalidomide vs observation did not improve 3-year PFS rates in patients carrying both ABCB1 and VEGF WT (P = .632).
Study details: This pharmacogenetic study included 278 adult patients with previously untreated MCL and adequate biological samples from the phase 3 MCL0208 study, 197 of whom were genotyped after ASCT and randomly assigned to the lenalidomide maintenance or observation arm.
Disclosures: This study was funded by Cancer Research UK and others. Some authors reported ties with various organizations.
Source: Ferrero S et al. Candidate germline biomarkers of lenalidomide efficacy in mantle cell lymphoma: The FIL MCL0208 trial. Blood Adv. 2023 (Apr 14). Doi: 10.1182/bloodadvances.2022009504
Venetoclax achieves a high undetectable measurable residual disease rate in ibrutinib-treated high-risk CLL
Key clinical point: The addition of venetoclax to ibrutinib treatment led to a high rate of undetectable measurable residual disease with 10–4 sensitivity (U-MRD4) in the bone marrow (BM) in high-risk patients with chronic lymphocytic leukemia (CLL).
Major finding: Adding venetoclax to ibrutinib therapy led to a cumulative BM U-MRD4 rate of 73%. BM U-MRD4 was achieved by 71% of patients after venetoclax therapy completion and by 38% and 57% of patients after 6 and 12 cycles, respectively.
Study details: This phase 2 study included 45 patients with CLL and detectable disease (≥0.01% measurable residual disease in BM) treated with ibrutinib for ≥12 months who had ≥1 high-risk feature for disease progression and received combined treatment with ibrutinib (previously tolerated dose) and venetoclax (escalated to 400 mg once daily) for ≤24 cycles.
Disclosures: This study was funded by AbbVie. Some authors declared serving as consultants or on speaker’s bureaus for or receiving advisory board or consulting honoraria or research support from AbbVie and others.
Source: Thompson PA et al. Venetoclax consolidation in high-risk CLL treated with ibrutinib for ≥1 year achieves a high rate of undetectable MRD. Leukemia. 2023 (May 3). Doi: 10.1038/s41375-023-01901-4
Key clinical point: The addition of venetoclax to ibrutinib treatment led to a high rate of undetectable measurable residual disease with 10–4 sensitivity (U-MRD4) in the bone marrow (BM) in high-risk patients with chronic lymphocytic leukemia (CLL).
Major finding: Adding venetoclax to ibrutinib therapy led to a cumulative BM U-MRD4 rate of 73%. BM U-MRD4 was achieved by 71% of patients after venetoclax therapy completion and by 38% and 57% of patients after 6 and 12 cycles, respectively.
Study details: This phase 2 study included 45 patients with CLL and detectable disease (≥0.01% measurable residual disease in BM) treated with ibrutinib for ≥12 months who had ≥1 high-risk feature for disease progression and received combined treatment with ibrutinib (previously tolerated dose) and venetoclax (escalated to 400 mg once daily) for ≤24 cycles.
Disclosures: This study was funded by AbbVie. Some authors declared serving as consultants or on speaker’s bureaus for or receiving advisory board or consulting honoraria or research support from AbbVie and others.
Source: Thompson PA et al. Venetoclax consolidation in high-risk CLL treated with ibrutinib for ≥1 year achieves a high rate of undetectable MRD. Leukemia. 2023 (May 3). Doi: 10.1038/s41375-023-01901-4
Key clinical point: The addition of venetoclax to ibrutinib treatment led to a high rate of undetectable measurable residual disease with 10–4 sensitivity (U-MRD4) in the bone marrow (BM) in high-risk patients with chronic lymphocytic leukemia (CLL).
Major finding: Adding venetoclax to ibrutinib therapy led to a cumulative BM U-MRD4 rate of 73%. BM U-MRD4 was achieved by 71% of patients after venetoclax therapy completion and by 38% and 57% of patients after 6 and 12 cycles, respectively.
Study details: This phase 2 study included 45 patients with CLL and detectable disease (≥0.01% measurable residual disease in BM) treated with ibrutinib for ≥12 months who had ≥1 high-risk feature for disease progression and received combined treatment with ibrutinib (previously tolerated dose) and venetoclax (escalated to 400 mg once daily) for ≤24 cycles.
Disclosures: This study was funded by AbbVie. Some authors declared serving as consultants or on speaker’s bureaus for or receiving advisory board or consulting honoraria or research support from AbbVie and others.
Source: Thompson PA et al. Venetoclax consolidation in high-risk CLL treated with ibrutinib for ≥1 year achieves a high rate of undetectable MRD. Leukemia. 2023 (May 3). Doi: 10.1038/s41375-023-01901-4