B-cell lymphoma

Marker Therapeutics Announces Sustained Complete Response in First Lymphoma Patient Treated with MT-601 following CAR T Relapse

Retrieved on: 
Monday, December 11, 2023

The patient had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy.

Key Points: 
  • The patient had diffuse large B cell lymphoma (DLBCL) and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy.
  • Marker reports today that six months following the initial treatment with MT-601 the study participant has maintained complete response to treatment.
  • “Relapse rates following CAR T cell therapy are high,” said Juan F. Vera, M.D., President and Chief Executive Officer of Marker Therapeutics.
  • “The ongoing complete response observed after MT-601 infusion in a CAR relapsed patient with lymphoma suggests superior durability of our therapy over CAR T cells in this patient.

Updated Odronextamab Data from Relapsed/Refractory Diffuse Large B-cell Lymphoma Pivotal Trial Showed Deep and Durable Responses and the Potential of ctDNA To Predict Long-term Outcomes

Retrieved on: 
Sunday, December 10, 2023

TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The data from the pivotal Phase 2 trial (ELM-2) and Phase 1 trial (ELM-1) were shared in several presentations – including two orals – at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition from December 9 to 12 in San Diego, CA. Odronextamab is an investigational CD20xCD3 bispecific antibody designed to bridge CD20 on cancer cells with CD3-expressing T cells to facilitate local T-cell activation and cancer-cell killing.

Key Points: 
  • TARRYTOWN, N.Y., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data for odronextamab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
  • “Diffuse large B-cell lymphoma has a high risk of relapse, which is why it is so critical to demonstrate continued disease control over the long term.
  • “The primary analysis from the pivotal trial of odronextamab demonstrated impressive response rates, including in certain high-risk subgroups.
  • A replay of the conference call and webcast will be archived on the company's website for at least 30 days.

Allogene Therapeutics Presents Comprehensive Safety Data of Proprietary Lymphodepletion Agent ALLO-647 at the 65th Annual Meeting of the American Society of Hematology

Retrieved on: 
Saturday, December 9, 2023

The addition of ALLO-647 to standard lymphodepletion did not result in adverse events beyond those commonly observed with autologous CAR T cell therapy.

Key Points: 
  • The addition of ALLO-647 to standard lymphodepletion did not result in adverse events beyond those commonly observed with autologous CAR T cell therapy.
  • Neutropenia and anemia were the most common any-grade treatment-emergent adverse events (or TEAEs) and neutropenia, anemia, and thrombocytopenia were the most common Grade 3 or higher TEAEs.
  • Grade 3 or higher cytopenias decreased over time from Day 28 to Month 4 and were consistent across all subsets of patients.
  • Incidence of Grade 3 or higher cytopenias were consistent with that reported for autologous CAR T cell therapy.2-4

U.S. FDA Approves Label Update for Kite’s Yescarta® CAR T-Cell Therapy to Include Overall Survival Data

Retrieved on: 
Thursday, December 21, 2023

The label update is based on results from the ZUMA-7 study which demonstrated a 27.4% reduction in the risk of death with Yescarta versus SOC, a relative 38% improvement in OS.

Key Points: 
  • The label update is based on results from the ZUMA-7 study which demonstrated a 27.4% reduction in the risk of death with Yescarta versus SOC, a relative 38% improvement in OS.
  • The estimated 39-month OS rates were 55.9% in the Yescarta arm and 46% in the SOC arm.
  • “Our ZUMA-7 overall survival analysis proves that when given as second-line therapy, Yescarta is even more effective in improving patient survival than standard of care treatment.
  • *Treatment of curative intent is a line of treatment administered with the goal of achieving a durable complete response/ remission.

Bionano Announces Presentation of OGM Utility Across Key Research Applications at the Association for Molecular Pathology Annual Meeting

Retrieved on: 
Tuesday, November 14, 2023

AMP’s annual meeting brings together industry, medical, and academic professionals to discuss advances in molecular diagnostics.

Key Points: 
  • AMP’s annual meeting brings together industry, medical, and academic professionals to discuss advances in molecular diagnostics.
  • The presenters will share data on OGM’s performance in this research application as compared to traditional cytogenetic methods of analysis, including microarrays.
  • Ryall, Dubuc and Crocker presenting clinical research data generated using OGM across different types of hematological malignancies.
  • In addition, 19 posters featuring results from OGM applications in cytogenetic research will be presented at the conference.

Vincerx Pharma Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 14, 2023

PALO ALTO, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC)(“Vincerx”), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Key Points: 
  • “We continue to take a very disciplined approach to our portfolio, focusing our resources on our two lead programs, VIP943 and VIP236.
  • We will present new data on robust preclinical activity at the 65th American Society for Hematology Meeting (ASH 2023) in December.
  • Collaborators from the University of Calgary will present a poster at ASH 2023 showing preclinical activity in pediatric leukemia.
  • For the quarter ended September 30, 2023, Vincerx reported a net loss of approximately $9.7 million, or $0.46 per share, compared to a net loss of approximately $16.9 million, or $0.80 per share, for the quarter ended September 30, 2022.

Nkarta Reports Third Quarter 2023 Financial Results and Corporate Highlights

Retrieved on: 
Thursday, November 9, 2023

In June 2023, Nkarta reported updated clinical data from its Phase 1 clinical trial evaluating NKX101 in patients with relapsed or refractory (r/r) AML.

Key Points: 
  • In June 2023, Nkarta reported updated clinical data from its Phase 1 clinical trial evaluating NKX101 in patients with relapsed or refractory (r/r) AML.
  • In October 2023, Nkarta announced the opening of a new cohort in its Phase 1 study of NKX019 in r/r NHL.
  • As of September 30, 2023, Nkarta had cash, cash equivalents, restricted cash, and investments of $278.4 million.
  • Net loss was $25.6 million, or $0.52 per basic and diluted share, for the third quarter of 2023.

CALQUENCE (Acalabrutinib) Emerging Drug Insights and Market Forecasts, 2019-2022 and 2023-2032: Focus on 7MM - United States, Germany, France, Italy, Spain, United Kingdom, and Japan - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 14, 2023

The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "CALQUENCE Emerging Drug Insight and Market Forecast - 2032" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights about CALQUENCE for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets.
  • Further, it also consists of future market assessments inclusive of the CALQUENCE market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of CALQUENCE in DLBCL.

Analyses of Kite’s Yescarta® CAR T-Cell Therapy Support Curative Potential in Patients With Non-Hodgkin Lymphomas

Retrieved on: 
Tuesday, December 12, 2023

In this post hoc analysis of ZUMA-1, with up to six years of follow-up, the five-year long-term lymphoma-related event-free survival (LREFS) was used as a measure to explore Yescarta’s curative potential.

Key Points: 
  • In this post hoc analysis of ZUMA-1, with up to six years of follow-up, the five-year long-term lymphoma-related event-free survival (LREFS) was used as a measure to explore Yescarta’s curative potential.
  • Yescarta had long-term LREFS in a substantial proportion of patients, with a five-year rate of 34% (57% among patients who achieved a CR).
  • Among patients who had a CR to therapy, the leading risks of death were reasons other than progression or adverse events after month 24 post-infusion.
  • “We are encouraged by these data, particularly the continued durable response and long-term survival in these patient populations that speak to the potentially curative benefit of this therapy.

Long-Term Data for Kite’s Yescarta® CAR T-Cell Therapy Presented at ASH 2023 Demonstrate High Rate of Durable Response in Patients With High-Risk Large B-Cell Lymphoma

Retrieved on: 
Monday, December 11, 2023

“Patients with high-risk, large B-cell lymphoma, have a poor prognosis with currently available therapies,” said Julio C. Chavez, MD, lead investigator, Moffitt Cancer Center.

Key Points: 
  • “Patients with high-risk, large B-cell lymphoma, have a poor prognosis with currently available therapies,” said Julio C. Chavez, MD, lead investigator, Moffitt Cancer Center.
  • “This is particularly true of patients with double- or triple-hit histology, who have a median survival of under a year with standard treatment.
  • Prolonged cytopenias of any grade (present Day ≥30 post-infusion) occurred in 9 patients (n=7 neutrophil count decreased) and were resolved by data cutoff.
  • Among treated patients, the in vivo Yescarta expansion and persistence profiles are consistent with previous observations.