ORR

Obsidian Therapeutics Announces Positive Interim Top-Line Clinical Data for OBX-115 Engineered TIL Cell Therapy in Advanced or Metastatic Melanoma Post-Anti-PD1 Therapy

Retrieved on: 
Tuesday, December 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Safety, Therapy, ICI, RECIST, University, National Resilience Institute, Disease, Patient, IL15, Monroe Dunaway Anderson, Neoplasm, DCR, ORR, Melanoma, IL2, CTMC, MD Anderson Cancer Center, TIL, Pharmaceutical industry, Obsidian

OBX-115 is an investigational novel IL2-sparing engineered TIL cell therapy armed with pharmacologically regulatable membrane-bound IL15 designed to enhance persistence, anti-tumor activity, and clinical safety of TIL cell therapy relative to unengineered TIL therapy plus high-dose IL2.

Key Points: 
  • OBX-115 is an investigational novel IL2-sparing engineered TIL cell therapy armed with pharmacologically regulatable membrane-bound IL15 designed to enhance persistence, anti-tumor activity, and clinical safety of TIL cell therapy relative to unengineered TIL therapy plus high-dose IL2.
  • , professor of Melanoma Medical Oncology and principal investigator of the study at The University of Texas MD Anderson Cancer Center.
  • “The OBX-115 data show its potential to be a meaningful advancement in the treatment of metastatic melanoma and TIL cell therapy,” said Parameswaran Hari, M.D., M.S., Chief Development Officer of Obsidian Therapeutics.
  • “These positive results underscore the potential for OBX-115 TIL cell therapy to offer patients with metastatic melanoma a differentiated TIL therapy without the need for IL2,” said Madan Jagasia, M.D., M.S., CEO of Obsidian Therapeutics.

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

Retrieved on: 
Tuesday, December 12, 2023
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Arm, Safety, Senior, Hope, Hypogammaglobulinemia, Ageing, ASH, University, EFS, B-cell lymphoma, Patient, Abstract, PFS, DOR, Follicular lymphoma, Lymphoma, DSS, Subgroup analysis, Standard of care, ORR, MD, Survival, Death, HR, Doctor of Philosophy, MD Anderson Cancer Center, Cancer, SOC, OS, Knowledge, Society, Confidence interval, Pharmaceutical industry, Axicabtagene ciloleucel

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
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, BCL2, Fever, MYC, Progression-free survival, ASH, Aes, CRS, EFS, B-cell lymphoma, Headache, Cytopenia, Non-Hodgkin lymphoma, Patient, Abstract, PFS, DOR, BCL6, Histology, ORR, MD, Survival, Doctor of Philosophy, Drug, Society, OS, Confidence interval, Axicabtagene ciloleucel, SVP, Cytokine release syndrome, Pharmaceutical industry

“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.

Electra Therapeutics presents first clinical data from ongoing Phase 1b study of ELA026 for treatment of secondary hemophagocytic lymphohistiocytosis (sHLH)

Retrieved on: 
Monday, December 11, 2023
Biotechnology, Health, Oncology, Clinical Trials, Assistant, IL2RA, CRP, Safety, C-reactive protein, Therapy, University, ASH, Disease, Patient, Peripheral T-cell lymphoma, Monoclonal antibody, Trial of the century, Prognosis, ORR, MD, HLH, Cancer, SIRP, Doctor of Philosophy, Biomarker, MD Anderson Cancer Center, Society, Pharmaceutical industry, Vaccine, Nursing

Data from ten sHLH patients in the ongoing Phase 1b clinical study showed favorable safety results and overall response rate (ORR) of 70% in all patients dosed with ELA026.

Key Points: 
  • Data from ten sHLH patients in the ongoing Phase 1b clinical study showed favorable safety results and overall response rate (ORR) of 70% in all patients dosed with ELA026.
  • The majority of enrolled patients were difficult-to-treat, malignancy-associated HLH and displayed poor prognostic clinical and biomarker features at baseline.
  • The Phase 1b study is an ongoing open-label, multi-dose, single-arm, multicenter study designed to evaluate the safety and efficacy of ELA026, assess biomarkers and identify a dose for Phase 2/3 testing (ClinicalTrials.gov identifier: NCT05416307 ).
  • “We are extremely encouraged by the data from the first two cohorts, and we look forward to continuing enrollment for this study as we advance the ELA026 clinical program.”

Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Paclitaxel, Tamoxifen, CDK, Food, Letrozole, Carcinoma, Fulvestrant, Progression-free survival, Doctor of Pharmacy, Breast cancer, Patient, Anastrozole, PFS, BID, FDA, Puma Biotechnology, DOR, DCR, ORR, PUMA, Phase, Biomarker, Cancer, Pharmaceutical industry, Birth control

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).
  • The Company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer in patients with these biomarkers.
  • “There continues to be a need for new drugs for the treatment of metastatic HER2-negative, hormone receptor-positive breast cancer,” said Alvin Wong, PharmD, Chief Scientific Officer of Puma Biotechnology.
  • “The clinical trials of alisertib to date in HER2-negative, hormone receptor-positive metastatic breast cancer have demonstrated alisertib’s potential clinical benefit in this patient population, and we look forward to initiating the PUMA-ALI-1201 trial in 2024.”
    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer.

New Analyses Presented at ASH 2023 Support the Potential Long-Term Response and Safety of Kite’s Tecartus® in Patients With Aggressive Blood Cancers

Retrieved on: 
Tuesday, December 12, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Hospitals, Clinical Trials, Hackensack University Medical Center, Safety, Cytokine release syndrome, Senior, City, ASH, Aes, CRS, Haematopoietic system, Sepsis, Patient, Abstract, Thrombocytopenia, Blinatumomab, The James Cancer Hospital, Division, SCT, Acute lymphoblastic leukemia, Neutropenia, ORR, Encephalopathy, B-ALL, Infection, Survival, Death, CD20, Doctor of Philosophy, Society, Abstract (summary), OS, Confidence interval, TP53, LD, Cytopenia, Pharmaceutical industry, Nursing, Hematology, Brexucabtagene autoleucel, Lymphoma, MD

“The clinical results and real-world evidence presented at ASH clearly support the potential for long-term response and safety of Tecartus in aggressive blood cancers for which patients have limited treatment options,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite.

Key Points: 
  • “The clinical results and real-world evidence presented at ASH clearly support the potential for long-term response and safety of Tecartus in aggressive blood cancers for which patients have limited treatment options,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite.
  • The median OS for patients with complete response (CR) (n=46) was 58.7 months.
  • Efficacy and safety outcomes for 23 patients with R/R MCL enrolled in ZUMA-18, a multicenter, open-label, expanded-access study of Tecartus, were also presented.
  • An analysis of a CIBMTR observational database of R/R MCL patients receiving Tecartus from 84 U.S. centers was presented.

Bristol Myers Squibb Announces Data at ASH 2023 from Diverse Multiple Myeloma Pipeline, Underscoring Range of Tailored Treatment Approaches to Address Unique Patient Needs

Retrieved on: 
Tuesday, December 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Dexamethasone, ASH, CRS, Patient, Cell, Infection, Bortezomib, B-cell maturation antigen, GPRC5D, Carfilzomib, Therapy, Bristol Myers Squibb, ORR, Cancer, Diagnosis, Anemia, International Myeloma Foundation, CD3, Cytokine release syndrome, Haematopoietic system, Multiple myeloma, Immunomodulatory imide drug, Safety, Immune system, Incidence, Aes, DOR, Science, Hook effect, Public, Drug discovery, Society, Estate (law), Lenalidomide, Proteasome inhibitor, Thrombocytopenia, PFS, BMY, Daratumumab, Neutropenia, Partnership, Skin, Life, Mezi proudy, Research, NYSE, Disease, MRD, Translational Genomics Research Institute, TCE, Survival, BMS, BCMA, Biology, Pharmaceutical industry, Vaccine, Fine chemical, Cohort, RRMM

Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.
  • These data were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California.
  • While multiple myeloma remains a relentless disease, we continue to transform the multiple myeloma treatment paradigm by dramatically improving outcomes for every patient.
  • As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

Abecma Delivers Sustained Progression-Free Survival Versus Standard Regimens in Earlier Lines of Therapy for Relapsed and Refractory Multiple Myeloma Based on Longer-Term Follow-up from KarMMa-3

Retrieved on: 
Tuesday, December 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Multiple myeloma, Bristol Myers Squibb, Oncology Drug Advisory Committee, NYSE, Safety, Research, Food, Bone marrow, European Medicines Agency, Progression-free survival, ASH, CRS, Cohort, Risk, Disease, Cytopenia, Patient, PFS, BMY, Doctor of Philosophy, Division, FDA, Cell therapy, ORR, ASCT, Death, Survival, Grade, Neurotoxicity, Society, BCMA, HIV disease progression rates, Cytokine release syndrome, Boxed warning, Pharmaceutical industry, Hematology, Swissmedic, Idecabtagene vicleucel, OS

With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens.

Key Points: 
  • With extended follow-up, treatment with Abecma (n=254) continued to demonstrate higher overall response rates (ORR) and a deepening of responses versus standard regimens.
  • Due to the median PFS observed with standard regimens, more than half (56%) of patients in the standard regimens arm crossed over to receive Abecma as a subsequent therapy.
  • Historically, based on real-world evidence, median OS for patients with triple-class exposed relapsed and refractory multiple myeloma is approximately 13 months.
  • Regulatory applications for Abecma in earlier lines of therapy for triple-class exposed relapsed and refractory multiple myeloma are also under review with the European Medicines Agency and Swissmedic.

Incyte and Syndax Present Additional Data from Positive AGAVE-201 Trial at ASH Plenary Session Showing Axatilimab Efficacy Including Durable Responses in Chronic Graft-Versus-Host Disease

Retrieved on: 
Sunday, December 10, 2023
Health, Surgery, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Fascia, Safety, Kaplan–Meier estimator, Food, Head, Esophagus, BLA, ASH, Lipase, Liver, Disease, Macrophage, Patient, Multimedia, Abstract, FDA, Joint, GVHD, CRS, GI, SNDX, ORR, Chocolate liquor, Development, Death, Mouth, Society, Skin, Biologics license application, Inflammation, Fibrosis, Pharmaceutical industry

The recommended dose of axatilimab for future trials in chronic GVHD is 0.3 mg/kg every two weeks.

Key Points: 
  • The recommended dose of axatilimab for future trials in chronic GVHD is 0.3 mg/kg every two weeks.
  • Organ-specific responses, including complete responses (CRs), were seen across all organs involved at baseline, including lower gastrointestinal (GI), upper GI, esophagus, joints/fascia, mouth, lungs, liver, eyes and skin.
  • Additionally, responses were notable in fibrosis-dominated organs, including the esophagus (78%), joints and fascia (76%), lungs (47%) and skin (27%).
  • "Full results from the AGAVE-201 trial show rapid durable responses documented in all organs and patient subgroups, with significant symptom burden reduction reported by most of these heavily-pretreated patients.

Two Early Studies Evaluating Potential First-in-Class CELMoD™ Agent Golcadomide for the Treatment of Non-Hodgkin Lymphomas Presented at ASH 2023

Retrieved on: 
Tuesday, December 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Bristol Myers Squibb, Safety, NYSE, Non-Hodgkin lymphoma, Pneumonia, ASH, Ikaros, Rituximab, Patient, Cell, Thrombocytopenia, BMY, Lymphoma, Death, CMR, DL, Neutropenia, ORR, Anemia, Society, NK, Febrile neutropenia, Pharmaceutical industry, Fever, DL-1, Hematology

Bristol Myers Squibb (NYSE: BMY) announced the results of two early studies evaluating combinations of potential first-in-class CELMoD™ agent golcadomide in non-Hodgkin lymphomas.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) announced the results of two early studies evaluating combinations of potential first-in-class CELMoD™ agent golcadomide in non-Hodgkin lymphomas.
  • These data are being presented in separate posters ( #4459 , #4496 , #1631 ) at the 2023 American Society of Hematology (ASH) Annual Meeting from December 9-12.
  • “In the studies being presented at ASH 2023, golcadomide has shown potential warranting further evaluation in patients with first-line and previously treated large B-cell lymphomas.
  • There were 4 deaths on treatment during the study with one considered related to the study treatment.