Breakthrough therapy

Longer-term Data for Kite’s Yescarta® in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in Comparative Analysis

Saturday, June 12, 2021 - 3:00pm

We are very encouraged by these data that suggest a significant and sustained survival benefit with Yescarta even after multiple rounds of prior treatment.

Key Points: 
  • We are very encouraged by these data that suggest a significant and sustained survival benefit with Yescarta even after multiple rounds of prior treatment.
  • In an indolent disease like follicular lymphoma, longer-term data that demonstrate durable responses are critical.
  • The continued durable benefit demonstrated by axicabtagene ciloleucel at nearly two years is exciting, and the substantial survival benefit over current therapies that were seeing in the SCHOLAR-5 analysis is encouraging.
  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

European Hematology Association: Overall Survival Benefit Established With Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) in Elderly Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma (NDMM): Long-Term Interim Analysis of the MAI

Saturday, June 12, 2021 - 8:00am

At a median follow-up of almost 5 years (56.2 months), we now report the pre-specified interim overall survival analysis of MAIA.

Key Points: 
  • At a median follow-up of almost 5 years (56.2 months), we now report the pre-specified interim overall survival analysis of MAIA.
  • These results are despite 46% of patients who received subsequent therapy in the Rd arm receiving daratumumab.
  • The high overall response rate (93% vs 82%) further demonstrated the added clinical benefit of D-Rd versus Rd alone.
  • The Congress is aimed at health professionals working in or interested in the field of hematology.

European Hematology Association - Daratumumab Maintenance Improves Progression-Free Survival After Autologous Stem Cell Transplantation in Multiple Myeloma Patients

Saturday, June 12, 2021 - 8:00am

The results of the study showed superior efficacy of D-VTd over VTd alone in combination with autologous stem cell transplantation (ASCT), which led to the regulatory approval of the treatment.

Key Points: 
  • The results of the study showed superior efficacy of D-VTd over VTd alone in combination with autologous stem cell transplantation (ASCT), which led to the regulatory approval of the treatment.
  • Our interim analysis showed that patients maintained with daratumumab exhibited significantly longer progression-free survival (PFS) compared to the observation treatment arm.
  • Patients who received D-VTd in part 1 and were placed on daratumumab maintenance showed comparable PFS to the observation group.
  • Furthermore, daratumumab maintenance led to a significantly higher depth of response and no new safety signals were detected.

European Hematology Association: Overall Survival Benefit Established With Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) in Elderly Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma (NDMM): Long-Term Interim Analysis of the MAI

Saturday, June 12, 2021 - 8:00am

At a median follow-up of almost 5 years (56.2 months), we now report the pre-specified interim overall survival analysis of MAIA.

Key Points: 
  • At a median follow-up of almost 5 years (56.2 months), we now report the pre-specified interim overall survival analysis of MAIA.
  • These results are despite 46% of patients who received subsequent therapy in the Rd arm receiving daratumumab.
  • The high overall response rate (93% vs 82%) further demonstrated the added clinical benefit of D-Rd versus Rd alone.
  • The Congress is aimed at health professionals working in or interested in the field of hematology.

European Hematology Association - Daratumumab Maintenance Improves Progression-Free Survival After Autologous Stem Cell Transplantation in Multiple Myeloma Patients

Saturday, June 12, 2021 - 8:00am

The results of the study showed superior efficacy of D-VTd over VTd alone in combination with autologous stem cell transplantation (ASCT), which led to the regulatory approval of the treatment.

Key Points: 
  • The results of the study showed superior efficacy of D-VTd over VTd alone in combination with autologous stem cell transplantation (ASCT), which led to the regulatory approval of the treatment.
  • Our interim analysis showed that patients maintained with daratumumab exhibited significantly longer progression-free survival (PFS) compared to the observation treatment arm.
  • Patients who received D-VTd in part 1 and were placed on daratumumab maintenance showed comparable PFS to the observation group.
  • Furthermore, daratumumab maintenance led to a significantly higher depth of response and no new safety signals were detected.

New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia

Saturday, June 12, 2021 - 8:00am

Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL.

Key Points: 
  • Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL.
  • Waldenstrms macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients.
  • Fixed-Duration Ibrutinib Plus Venetoclax (I+V) Versus Chlorambucil Plus Obinutuzumab (Clb+O) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL): Primary Analysis of the Phase 3 GLOW Study.
  • Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study Leukemia.

Sorrento Announces Clinical Research Agreement With Mayo Clinic and FDA Clearance for the First Phase 1b Pilot Study Using Sofusa Lymphatic Drug Delivery Technology to Deliver Ipilimumab in Patients With Melanoma

Friday, June 11, 2021 - 2:00pm

The first study resulting in this agreement is MC20711, a Phase 1b study of the administration of Ipilimumab Intra-Lymphatically using the Sofusa DoseConnect in Patients with Metastatic Melanoma.

Key Points: 
  • The first study resulting in this agreement is MC20711, a Phase 1b study of the administration of Ipilimumab Intra-Lymphatically using the Sofusa DoseConnect in Patients with Metastatic Melanoma.
  • This agreement builds upon the previously announced exclusive licensing agreement where Sorrento licensed Mayo Clinics proprietary Antibody-Drug-Nanoparticle albumin-bound Immune Complex platform technology.
  • Mayo Clinic, Dr. Svetomir Markovic and Dr. James Jakub have financial interests in the technology referenced in this release.
  • RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients.

European Hematology Association - ALPINE Study Reveals Superior Safety and Efficacy of Zanubrutinib Compared with Ibrutinib

Friday, June 11, 2021 - 8:00am

Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib.

Key Points: 
  • Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib.
  • The activity and tolerability of zanubrutinib have been demonstrated in patients with CLL/SLL in early phase clinical trials.
  • The ALPINE study solidifies the findings of these pivotal trials by a head-to-head comparison of the safety and efficacy of zanubrutinib and ibrutinib in 415 patients with relapsed/refractory CLL/SLL.
  • In summary, zanubrutinib showed more selective inhibition of BTK resulting in improved efficacy and safety compared with ibrutinib.

European Hematology Association - ALPINE Study Reveals Superior Safety and Efficacy of Zanubrutinib Compared with Ibrutinib

Friday, June 11, 2021 - 8:00am

Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib.

Key Points: 
  • Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib.
  • The activity and tolerability of zanubrutinib have been demonstrated in patients with CLL/SLL in early phase clinical trials.
  • The ALPINE study solidifies the findings of these pivotal trials by a head-to-head comparison of the safety and efficacy of zanubrutinib and ibrutinib in 415 patients with relapsed/refractory CLL/SLL.
  • In summary, zanubrutinib showed more selective inhibition of BTK resulting in improved efficacy and safety compared with ibrutinib.

X4 Pharmaceuticals Announces Presentation of Positive Data from Ongoing Phase 1b Clinical Trial of Mavorixafor in Waldenström’s Macroglobulinemia at EHA 2021

Friday, June 11, 2021 - 8:00am

We are very pleased to present this exciting first look at the data from our ongoing Phase 1b trial in double-mutation Waldenstrms patients, said Diego Cadavid, M.D., Chief Medical Officer of X4 Pharmaceuticals.

Key Points: 
  • We are very pleased to present this exciting first look at the data from our ongoing Phase 1b trial in double-mutation Waldenstrms patients, said Diego Cadavid, M.D., Chief Medical Officer of X4 Pharmaceuticals.
  • We look forward to presenting longer-term data and an expanded data set from this trial later in the year.
  • Mavorixafor exposures tracked with sustained and dose-dependent increases in white blood cell counts, confirming target engagement and mavorixafor mechanism of action.
  • The e-poster (EP784) entitled: Preliminary Clinical Data From a Phase 1b Study of Mavorixafor and Ibrutinib in Patients With Waldenstrms Macroglobulinemia With MYD88 and CXCR4 Mutations is now available on the X4 corporate website .