Lenalidomide

Starton Therapeutics Announces Initial Key Safety and Efficacy Signals with STAR-LLD in Patients with Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Wednesday, January 3, 2024
Quality of life, Leukopenia, URTI, Constipation, Lower respiratory tract infection, IND, Insomnia, CD8, Diarrhea, PD-1, DVT, Anemia, Gastroenteritis, Tremor, Fatigue, Common, CD4, Nausea, Multiple myeloma, Neutropenia, Abdominal pain, Therapy, Lenalidomide, Pharmacokinetics, Weakness, Dizziness, Thrombocytopenia, Cytotoxic T cell, Dexamethasone, Appetite, Periodic breathing, Bortezomib, Toxicity, Back pain, Patient, Safety, Peripheral edema, Deep vein thrombosis, Vomiting, Cough, Rash, Bronchitis

Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date. Only a single drug-related adverse event was reported -- subcutaneous induration at the injection site which resolved within two weeks. In comparison, adverse events in these patients observed during a prior regimen containing Revlimid® included nausea, vomiting, deep vein thrombosis (DVT), upper respiratory tract infections (URTI), anemia, and fatigue. None of the more common side effects of lenalidomide (Revlimid®), which include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor, have been observed with STAR-LLD. Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects. These data suggest that STAR-LLD may prove to be superior in tolerability to oral Revlimid, expanding the number of patients that get the full Revlimid® benefit and improving quality of life.

Key Points: 
  • Patient acceptance of self-administration using the ambulatory pump for lenalidomide delivery has been confirmed in this study.
  • Remarkably, there were no hematologic toxicities greater than Grade 1 observed to date.
  • Only a single drug-related adverse event was reported -- subcutaneous induration at the injection site which resolved within two weeks.
  • Up to 30% of patients discontinue use of Revlimid® and roughly 70% dose reduce as a result of these adverse effects.

Human medicines European public assessment report (EPAR): Pomalidomide Viatris, pomalidomide, Status: Opinion

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, European Commission, INN, Physician, ATC, EMA, International, Multiple myeloma, Civil service commission, Lenalidomide, Dexamethasone, Bortezomib, Medication package insert, Committee, Patient, Anatomy, Medicine, CHMP, Generic drug

Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules.

Key Points: 
  • Pomalidomide Viatris will be available as 1 mg, 2 mg, 3 mg and 4 mg hard capsules.
  • Pomalidomide Viatris is a generic of Imnovid, which has been authorised in the EU since 05 August 2013.
  • Studies have demonstrated the satisfactory quality of Pomalidomide Viatris and its bioequivalence to the reference product Imnovid.
  • Treatment with Pomalidomide Viatris should be carried out under the supervision of physicians experienced in the treatment of multiple myeloma.

Starton Therapeutics to Present at Biotech Showcase 2024 in San Francisco

Retrieved on: 
Monday, December 18, 2023
Biotechnology, Therapy, Lenalidomide

PARAMUS, N.J., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc., (the “Company”) a clinical-stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, today announced that Pedro Lichtinger, Chairman & Chief Executive Officer of Starton Therapeutics, will present a company overview including an update on interim data of its ongoing STAR-LLD Phase 1B continuous delivery of lenalidomide.

Key Points: 
  • PARAMUS, N.J., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc., (the “Company”) a clinical-stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, today announced that Pedro Lichtinger, Chairman & Chief Executive Officer of Starton Therapeutics, will present a company overview including an update on interim data of its ongoing STAR-LLD Phase 1B continuous delivery of lenalidomide.
  • The presentation is taking place at Biotech Showcase being held in San Francisco, CA on January 8-10, 2024.
  • Details for the event are as follows:

Press Release: Sarclisa® (isatuximab) plus KRd significantly improved rate of minimal residual disease negativity in transplant-eligible patients with newly diagnosed multiple myeloma versus KRd alone

Retrieved on: 
Monday, December 11, 2023
Isatuximab, ASCT, ITT, Associate, Bone marrow, EMN, MRD, Young, Multiple myeloma, Society, University of Turin, Lenalidomide, Odds ratio, ASH, University, Dexamethasone, NCAA University Division, AOU, Cell, Patient, Carfilzomib

The Phase 3 trial investigating Sarclisa® (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM).

Key Points: 
  • The Phase 3 trial investigating Sarclisa® (isatuximab) in combination with carfilzomib, lenalidomide and dexamethasone (KRd) showed a statistically significant improvement in the rate of minimal residual disease (MRD) negativity, compared with KRd alone, after autologous stem cell transplant (ASCT) consolidation in transplant-eligible patients with newly diagnosed multiple myeloma (MM).
  • The respective rates of MRD negativity at sensitivity of 10-6 were 67% versus 48% (OR 1.93; p=0.006).
  • There was a statistically significant difference in MRD negativity rates after induction with Sarclisa in combination with KRd versus KRd (10-5: 45% versus 26%, p
  • Effective front-line treatment is critical for newly diagnosed patients, because achieving undetectable levels of disease early in the treatment journey may lead to better long-term outcomes.

Press Release: Sarclisa® (isatuximab) Phase 3 trial met primary endpoint of progression free survival in patients with newly diagnosed multiple myeloma not eligible for transplant

Retrieved on: 
Thursday, December 7, 2023
Progression-free survival, Multiple myeloma, Lenalidomide, Standard of care, Dexamethasone, Bortezomib, Patient, Safety, PFS

First global Phase 3 study to report positive results with an anti-CD38 therapy in combination with VRd in transplant-ineligible patients, reinforcing the potential for Sarclisa as a best-in-class medicine

Key Points: 
  • First global Phase 3 study to report positive results with an anti-CD38 therapy in combination with VRd in transplant-ineligible patients, reinforcing the potential for Sarclisa as a best-in-class medicine
    PARIS, December 7, 2023.
  • The Phase 3 IMROZ trial evaluating the investigational use of Sarclisa® (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) met its primary endpoint at a planned interim analysis for efficacy, demonstrating statistically significant improvement in progression-free survival (PFS) compared with VRd alone in transplant-ineligible patients with newly diagnosed multiple myeloma (MM).
  • This is also the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care.
  • "This is the second Phase 3 trial investigating Sarclisa in newly diagnosed patients to show superiority versus standard of care, reinforcing our belief in Sarclisa as a best-in-class medicine.

Starton Therapeutics Completes One Third of STAR-LLD Study Enrollment

Retrieved on: 
Monday, November 20, 2023
Dexamethasone, Multiple myeloma, Safety, Therapy, Patient, Bortezomib, Animal, Pharmacokinetics, Dietary supplement, Lenalidomide

PARAMUS, N.J., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical stage biotechnology company transforming standard of care therapies with proprietary dermal technologies, announced today that it has enrolled one third of its STAR-LLD 1b clinical trial.

Key Points: 
  • PARAMUS, N.J., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical stage biotechnology company transforming standard of care therapies with proprietary dermal technologies, announced today that it has enrolled one third of its STAR-LLD 1b clinical trial.
  • The study is assessing the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in combination with dexamethasone and bortezomib (Velcade®) in 28-day cycles.
  • Second-line transplant ineligible, relapsed/refractory multiple myeloma patients are eligible for the study.
  • “Enrolling one third of the patients required for the study within two months of site activation is a phenomenal achievement,” said Dr. Jamie Oliver, Starton’s Chief Medical Officer.

MONJUVI (tafasitamab-cxix) 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: 
Friday, December 15, 2023
Pharmaceutical, Health, Oncology, Health Canada, Research, Immune system, Lenalidomide, European Commission, MHRA, Clinical trial, Civil service commission, Tafasitamab, CD19, ADCC, SWOT, EU4, ADCP, Fine chemical, Vaccine, Pharmaceutical industry, Risk management, DLBCL

This "MONJUVI Drug Insight and Market Forecast - 2032" report provides comprehensive insights about MONJUVI for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets.

Key Points: 
  • This "MONJUVI Drug Insight and Market Forecast - 2032" report provides comprehensive insights about MONJUVI for Diffuse Large B-cell lymphoma (DLBCL) in the seven major markets.
  • The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities.
  • Further, it also consists of future market assessments inclusive of the MONJUVI market forecast analysis for DLBCL in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in DLBCL.
  • What are the other emerging products available and how are these giving competition to MONJUVI for DLBCL?

New Data for Genentech’s Columvi and Lunsumio Presented at ASH 2023 Support Continued Benefit for People With Lymphoma

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Doxorubicin, Safety, Lenalidomide, Progression-free survival, Bone marrow, ASH, CRS, Disease, DLBCL, Prednisone, B-cell lymphoma, Rituximab, Patient, Roche, PFS, ROG, Follicular lymphoma, Phases of clinical research, Polatuzumab vedotin, Exposition, Vincristine, GemOx, Cyclophosphamide, Society, OS, Cytokine release syndrome, HIV disease progression rates, Lymphoma, Fine chemical, Pharmaceutical industry, Medical device, Mosunetuzumab, Genentech, Phase, Nature Medicine

Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Key Points: 
  • Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).
  • After a median follow-up of 32 months, 55% of patients with a complete response (CR) were in remission at 24 months.
  • Data showed that 83.3% of patients achieved a complete metabolic response (95% CI: 62.6-95.3), and responses were ongoing at data cut-off.
  • The data support further investigation of this SC formulation of Lunsumio and highlight its potential as a tailored monotherapy or combination outpatient therapy for FL, including in community practices.

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.

Latest Data of InnoCare’s Oncology Pipelines Presented at the 65th Annual Meeting of ASH

Retrieved on: 
Monday, December 11, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, HKEX, Rituximab, Lenalidomide, Toxicity, Treatment, Progression-free survival, Lymphoid leukemia, MCL, ASH, Aes, Refractory, Bleeding, Patient, Abstract, PFS, Impact, TLS, POLARIS, MRD, DOR, Pharmacokinetics, OLR, Atrial fibrillation, Medicine, SSE, ORR, Diarrhea, Cancer, Peking Union Medical College, Zhongshan Hospital, Fudan University, CRR, Infrared spectroscopy correlation table, Society, TTR, Relapse, B-cell lymphoma, Hospital, Pharmaceutical industry, Vaccine, Medical imaging, Management, Safety

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the latest data from InnoCare’s oncology studies were presented at the 65th American Society of Hematology (ASH) Annual Meeting.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the latest data from InnoCare’s oncology studies were presented at the 65th American Society of Hematology (ASH) Annual Meeting.
  • The study of orelabrutinib’s regimen in patients with untreated mantle cell lymphoma (MCL) was selected as an oral presentation.
  • The overall response rate (ORR) was 100%, and the complete response rate (CRR) was 76.2%.
  • This retrospective data suggests that orelabrutinib in combination with rituximab has an encouraging anti-tumor activity in MZL, with a favorable safety profile.