Obinutuzumab

Lupus Nephritis Market Expected to Grow as Novel Therapies Enter Clinical Trials

14 days ago

• The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions. • Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations. • Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.

Balancing Efficacy and Cost Sustainability in Modern CLL Treatment: Insights from Dr. Pierluigi Porcu

a month ago

• Clinicians treating chronic lymphocytic leukemia (CLL) face growing challenges in balancing clinical efficacy with long-term cost sustainability, requiring a holistic approach to patient care. • Dr. Pierluigi Porcu emphasizes that effective CLL management requires understanding disease risk, patient comorbidities, and practice environment constraints including payer considerations. • Despite its importance, value-based care adoption remains insufficient in oncology, with challenges in defining and measuring value across patient outcomes, quality of life, and treatment costs.

Over 220 Pipeline Therapies in Development for Non-Hodgkin's Lymphoma, Reports DelveInsight

2 months ago

• DelveInsight's 2025 pipeline report reveals more than 200 companies developing 220+ therapies for Non-Hodgkin's Lymphoma, demonstrating robust research activity in this therapeutic area. • Key investigational therapies include Mosunetuzumab (Roche), Tisagenlecleucel (Novartis), Capivasertib (AstraZeneca), BI-1206 (BioInvent), and HMPL-760 (Hutchmed), each employing distinct mechanisms of action. • Novel approaches include T-cell bispecific antibodies, CAR-T cell therapies, AKT inhibitors, and next-generation BTK inhibitors, addressing treatment resistance and improving outcomes for relapsed/refractory patients.

FDA Grants Fast Track Designation to Artiva's AlloNK Cell Therapy for Autoimmune Diseases

2 months ago

• Artiva Biotherapeutics has received FDA Fast Track designation for AlloNK therapy in autoimmune diseases, potentially accelerating development through enhanced agency communication and rolling application options. • The company is conducting two clinical trials: a company-sponsored study focusing on lupus patients and an investigator-initiated trial exploring lupus, rheumatoid arthritis, pemphigus vulgaris, and vasculitis. • AlloNK's novel mechanism combines traditional monoclonal antibodies with allogeneic NK cells, positioning it between conventional B-cell depletion therapies and engineered CAR-T approaches for autoimmune conditions.

Novel Therapies Transform Rheumatology Landscape in Early 2025

3 months ago

• FDA regulatory actions in Q1 2025 include approval of Celltrion's denosumab biosimilars and Fast Track designation for CAR-T therapies targeting lupus, expanding treatment options for autoimmune conditions. • Breakthrough clinical data from the REGENCY trial demonstrates obinutuzumab's superior efficacy in lupus nephritis, while rosnilimab shows historic response rates in rheumatoid arthritis patients. • Novel approaches for difficult-to-treat conditions emerge with SAP-001 showing "best-in-class" results for refractory gout and transcranial magnetic stimulation providing sustained pain relief for fibromyalgia.

Gazyva Shows Significant Improvement in Lupus Nephritis Treatment: Phase III REGENCY Trial Results

3 months ago

• Genentech's Phase III REGENCY trial demonstrates that Gazyva plus standard therapy achieved 46.4% complete renal response in lupus nephritis patients compared to 33.1% with standard therapy alone. • The study, published in NEJM, showed clinically meaningful improvements in complement levels and reductions in anti-dsDNA markers, indicating reduced disease activity and inflammation. • Results were consistent across all patient subgroups, including those with Class IV lupus nephritis and higher baseline proteinuria levels, while maintaining Gazyva's established safety profile.

Bain Capital Acquires Mitsubishi Tanabe Pharma in $3.3 Billion Deal

3 months ago

• Bain Capital has agreed to acquire Mitsubishi Tanabe Pharma, a 350-year-old pharmaceutical company, in a deal valued at $3.3 billion, aiming to capitalize on growth opportunities in Japan's life sciences sector. • The acquisition will transform Mitsubishi Tanabe into a standalone company, focusing on vaccine development and treatments for neurological, cardiometabolic, and immunological conditions. • The Osaka-based company, which employs over 5,000 people globally, will maintain its operations while benefiting from Japan's initiatives to accelerate drug development.

Novel Approaches Reshape Lymphoma Treatment Landscape: Bispecific Antibodies and MRD-Guided Therapy Show Promise

4 months ago

• Bispecific antibodies demonstrate remarkable response rates in both diffuse large B-cell and follicular lymphoma, with promising durability in frontline treatment settings. • Groundbreaking ECOG-ACRIN trial reveals MRD-negative mantle cell lymphoma patients may not require stem cell transplantation, potentially changing decades of standard practice. • Research initiatives are expanding to include older lymphoma patients and focus on quality-of-life outcomes, with new trial designs better reflecting real-world patient populations.

Acalabrutinib Receives FDA Approval for Previously Untreated Mantle Cell Lymphoma

4 months ago

• The FDA has granted traditional approval to acalabrutinib in combination with bendamustine and rituximab for untreated MCL patients ineligible for stem cell transplant. • The approval was based on the ECHO trial, which showed a 27% reduction in disease progression or death compared to chemoimmunotherapy alone. • Median progression-free survival was 66.4 months with acalabrutinib versus 49.6 months with chemoimmunotherapy, demonstrating a clinically significant improvement. • Acalabrutinib is now the first and only BTK inhibitor approved for first-line MCL treatment, offering a new option for this rare and aggressive cancer.

Third-Generation CAR T-Cell Therapy Shows Promise in Relapsed/Refractory CLL

5 months ago

• A phase 1/2 study of HD-CAR-1, a third-generation CAR T-cell therapy, demonstrates encouraging response rates in heavily pretreated CLL patients. • Six of nine patients (67%) achieved complete remission (CR) three months post-treatment, with 83% showing undetectable minimal residual disease. • With a median follow-up of 27 months, the progression-free survival rate was 30%, and achieving CR correlated with significantly longer PFS (P = .024). • The therapy showed a favorable safety profile, with only one case of grade 3 cytokine release syndrome and no neurotoxicity observed.

Novel Regimens Show Promise in CLL/SLL Treatment, Offering Durable Remissions and Improved Outcomes

5 months ago

• Fixed-duration ibrutinib and venetoclax demonstrate durable progression-free survival in CLL/SLL, even in high-risk patients, offering an easy-to-administer, all-oral option. • Zanubrutinib and venetoclax combination shows high efficacy in relapsed/refractory CLL, including those with prior BTK or BCL2 inhibitor exposure, with manageable tolerability. • Zanubrutinib monotherapy demonstrates superior progression-free survival compared to bendamustine/rituximab in treatment-naive CLL/SLL patients without del(17p) after 5-year follow-up. • Time-limited zanubrutinib/rituximab therapy induces durable remissions in treatment-naive CLL, suggesting a potential alternative to long-term BTK inhibitor monotherapy.

ASH 2024: Advances in Leukemia, Sickle Cell Disease, and Multiple Myeloma Therapies

5 months ago

• Lilly's Jaypirca demonstrated superior efficacy in relapsed/refractory CLL patients previously treated with BTK inhibitors, nearly doubling the time to disease progression compared to older regimens. • AstraZeneca's Calquence, combined with Venclexta, reduced the risk of disease progression or death by 35% in previously untreated CLL, offering a potential alternative to chemoimmunotherapy. • Pfizer's withdrawal of Oxbryta for sickle cell disease raised concerns about safety monitoring and data transparency, prompting discussions on appropriate endpoints for regulatory approvals. • Bristol Myers Squibb presented promising Phase 1 data for arlo-cel, a CAR-T therapy targeting GPRC5D in multiple myeloma, showing high response rates in heavily pre-treated patients.

Year in Review: Chronic Lymphocytic Leukemia

5 months ago

This year marked significant advancements in the treatment of Chronic Lymphocytic Leukemia (CLL), including the first FDA approval of CAR T-cell therapy for CLL, promising treatments for Richter transformation, and the exploration of triplet regimens. Additionally, updates on drug pricing and labeling changes were noted, alongside new data on treatment efficacy and safety.

Lisocabtagene Maraleucel Shows Promise in Relapsed/Refractory Lymphomas

5 months ago

• Lisocabtagene maraleucel (liso-cel) demonstrates efficacy and safety in second-line treatment of relapsed/refractory large B-cell lymphoma (LBCL), aligning with pivotal trial outcomes. • The TRANSCEND FL trial indicates liso-cel achieved a significant overall response rate in relapsed/refractory marginal zone lymphoma (MZL), meeting the primary endpoint. • Five-year data from TRANSCEND-NHL-001 underscore the curative potential of liso-cel in third-line LBCL, showing a 38% overall survival rate. • Real-world data supports liso-cel's effectiveness across diverse LBCL patient subgroups, reinforcing its role as a standard-of-care treatment option.

Acalabrutinib Plus Venetoclax Significantly Improves PFS in Untreated CLL

5 months ago

• The phase 3 AMPLIFY trial demonstrated that acalabrutinib plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival (PFS) in treatment-naive CLL patients. • The doublet and triplet regimens reduced the risk of disease progression or death by 35% and 58%, respectively, compared to chemoimmunotherapy. • The highest rates of undetectable minimal residual disease (uMRD) were observed in patients treated with the triplet regimen of acalabrutinib, venetoclax, and obinutuzumab. • The combination provides a chemotherapy-free, fixed-duration option for previously untreated CLL, offering improved outcomes and flexibility in managing the disease.

Zamto-cel Shows Promise in Relapsed/Refractory DLBCL with Tandem CD20/CD19 Targeting

5 months ago

• Zamto-cel, a tandem CD20/CD19 CAR T-cell therapy, demonstrated a 72.8% overall response rate and a 50.8% complete remission rate in r/r DLBCL patients. • The median duration of response was 11.4 months, and the median progression-free survival was 9.0 months, indicating durable responses. • Zamto-cel exhibited a favorable safety profile, with low rates of high-grade cytokine release syndrome and neurotoxicity. • Antigen loss was not a major driver of disease progression, supporting the dual-targeting approach of zamto-cel.

Venetoclax Enhances CAR T-Cell Therapy Response in Chronic Lymphocytic Leukemia

5 months ago

• Roswell Park Comprehensive Cancer Center research elucidates how venetoclax synergizes with CAR T-cell therapy to combat chronic lymphocytic leukemia (CLL). • Venetoclax strengthens cancer-killing T lymphocytes, improving their function and fitness when combined with CAR T-cell therapy. • The study involved multiomic analysis of blood samples from 14 CLL patients, revealing specific changes in immune cells after venetoclax treatment. • Findings suggest venetoclax could repair the immune system in CLL patients, potentially leading to more effective combination treatments.

Incyte's Retifanlimab Shows Positive Phase 3 Results in Non-Small Cell Lung Cancer

5 months ago

• Incyte's Phase 3 POD1UM-304 trial showed retifanlimab plus chemotherapy significantly improved overall survival in NSCLC patients. • The combination therapy resulted in a median overall survival of 18.1 months compared to 13.4 months with chemotherapy alone. • The study also met secondary endpoints, including progression-free survival, overall response rate, and duration of response. • Incyte plans to submit a supplemental Biologics License Application to the FDA in 2025.

FDA Accepts sBLA for Glofitamab Plus Chemotherapy in Relapsed/Refractory DLBCL

6 months ago

• The FDA has accepted Roche's sBLA for glofitamab combined with gemcitabine and oxaliplatin (GemOx) for relapsed/refractory DLBCL patients ineligible for autologous stem cell transplant. • The sBLA is based on the phase 3 STARGLO trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to rituximab plus GemOx. • The FDA is expected to make a decision on the approval of glofitamab in combination with GemOx by July 20, 2025, offering a potential new treatment option. • The safety profile of glofitamab plus GemOx was consistent with the known safety profiles of the individual agents, with cytokine release syndrome being a common adverse event.

Novel Therapies Show Promise in Relapsed/Refractory CLL After BTK Inhibitor and Venetoclax Failure

6 months ago

• Emerging data highlight the increasing need for effective treatments for chronic lymphocytic leukemia (CLL) patients who progress after covalent BTK inhibitors and venetoclax. • Lisocabtagene ciloleucel (liso-cel; Breyanzi) has received FDA approval for CLL patients with 2 or more prior lines of therapy, demonstrating a complete response rate in a subset of patients. • BTK degraders like BGB-16673 and NX-5948 are showing promising early results in relapsed/refractory CLL, including those with BTK mutations, with manageable safety profiles. • Bispecific antibodies such as epcoritamab-bysp (Epkinly) are also demonstrating encouraging response rates in heavily pre-treated CLL patients, offering a potential new treatment avenue.

Drug Development Updates