Tafasitamab

PharmaMar Expands Global Reach of Zepzelca with Argentina Approval and Merck Partnership for Japan

2 months ago

• PharmaMar and partner Adium Pharma have secured conditional marketing approval for Zepzelca (lurbinectedin) in Argentina for treating metastatic small cell lung cancer, extending the drug's availability to 18 territories globally. • The company has simultaneously formed an exclusive license agreement with Merck for Zepzelca's development and commercialization in Japan, receiving an initial payment of €22 million with potential for €31 million more in milestone payments. • These strategic moves strengthen PharmaMar's position in the oncology market while providing new treatment options for patients with an aggressive form of lung cancer across multiple regions.

Knight Therapeutics Launches Minjuvi for Relapsed/Refractory DLBCL in Mexico

2 months ago

• Knight Therapeutics has launched Minjuvi (tafasitamab) in Mexico for adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for autologous stem cell transplantation. • The approval was based on the L-MIND Phase 2 trial, which demonstrated a 60% objective response rate and 43% complete response rate when Minjuvi was used in combination with lenalidomide. • Minjuvi, a humanized Fc-modified CD19-targeting monoclonal antibody, is recognized in the 2025 NCCN Guidelines as a preferred second-line treatment option for transplant-ineligible DLBCL patients.

InnoCare's BCL2 Inhibitor ICP-248 Combination Therapy Advances to Phase III Trial for First-line CLL/SLL Treatment in China

3 months ago

• China's NMPA has approved InnoCare's registrational Phase III trial of BCL2 inhibitor ICP-248 (Mesutoclax) combined with orelabrutinib for first-line CLL/SLL treatment. • The ICP-248 and orelabrutinib combination demonstrated promising efficacy and safety in Phase II trials, offering potential for deeper remission in treatment-naïve CLL/SLL patients. • With global CLL incidence at 191,000 new cases annually and rising rates in China, this fixed-duration combination therapy represents a significant advancement in treatment options.

Incyte Reports Strong 2024 Growth with $4.2B Revenue, Outlines Ambitious 2025 Pipeline Milestones

3 months ago

• Incyte achieved total revenues of $4.2 billion in 2024, marking a 15% year-over-year growth, driven by strong performance of Jakafi ($2.8B) and Opzelura ($508M). • The company anticipates four new product launches in 2025, including Niktimvo for chronic GVHD and expanded indications for existing therapies in atopic dermatitis and lymphoma. • Incyte's R&D pipeline shows significant advancement with plans for four pivotal study readouts, three Phase 3 study initiations, and seven proof-of-concept study results expected in 2025.

Dual Targeting PD-L1 and 4-1BB Overcomes Lenalidomide Resistance in Follicular Lymphoma

4 months ago

• A phase 2 trial identified dendritic cells (DCs) as critical in follicular lymphoma (FL) progression under rituximab plus lenalidomide (R2) treatment, highlighting the need for new strategies. • PU.1, a transcription factor, mediates lenalidomide resistance by modulating PD-L1 and 4-1BB interaction between lymphoma cells and DCs, impacting anti-tumor immunity. • Dual targeting of PD-L1 and 4-1BB with a bispecific antibody counteracts PU.1-mediated alterations in DCs, enhancing lymphoma cell autophagy and anti-tumor activity in vitro and in vivo. • The study suggests that combining immune checkpoint modulation with lenalidomide could be a promising chemo-free immunotherapy approach for overcoming resistance in FL treatment.

Retifanlimab Plus Chemotherapy Shows Promise in Advanced Squamous Cell Anal Carcinoma

5 months ago

• Phase 3 POD1UM-303 trial shows retifanlimab combined with chemotherapy significantly improves progression-free survival in patients with locally recurrent or metastatic squamous cell anal carcinoma (SCAC). • The combination therapy demonstrated a median PFS of 9.3 months compared to 7.4 months with chemotherapy alone, marking a potential new standard of care. • Interim overall survival data also suggest a trend towards improvement with the addition of retifanlimab, with manageable immune-related adverse effects. • The study's success supports a planned supplemental biologics license application (sBLA) for retifanlimab, offering hope for addressing unmet needs in SCAC treatment.

Monjuvi Combination Shows Promise in Relapsed/Refractory Follicular Lymphoma

5 months ago

• The combination of Monjuvi, Revlimid, and Rituxan significantly reduces the risk of disease progression or death in relapsed/refractory follicular lymphoma patients. • The inMIND phase 3 trial demonstrated a median progression-free survival of 22.4 months with the Monjuvi combination, compared to 13.9 months with Revlimid and Rituxan alone. • The Monjuvi combination showed improved objective response rates and duration of response compared to the Revlimid and Rituxan doublet. • Incyte plans to file for FDA approval of Monjuvi combination for relapsed/refractory follicular lymphoma based on the inMIND trial results.

Tafasitamab Demonstrates Real-World Efficacy in Relapsed/Refractory DLBCL

5 months ago

• A real-world study evaluating tafasitamab in US patients with relapsed/refractory DLBCL showed a progression-free survival of 11.3 months. • The overall survival in the study population was 24.8 months, with an overall response rate of 73.5%, including complete and partial responses. • Factors such as later lines of therapy, advanced Ann Arbor stage, and bulky disease were associated with increased risk of progression and mortality. • The greatest clinical benefit was observed when tafasitamab was administered in the second line of therapy for relapsed/refractory DLBCL.

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.

Incyte Highlights New Tafasitamab Data in Follicular Lymphoma at ASH 2024

6 months ago

• Incyte will present new data from its oncology portfolio at the 2024 American Society of Hematology (ASH) Annual Meeting in San Diego. • A late-breaking oral presentation will feature results from the Phase 3 inMIND study evaluating tafasitamab in relapsed or refractory follicular lymphoma (FL). • Incyte will host a virtual analyst and investor event on December 12, 2024, to discuss key data presentations from ASH.

Delayed Treatment May Improve Outcomes for Older DLBCL Patients, Study Suggests

6 months ago

• A recent study indicates that older adults with Diffuse Large B-cell Lymphoma (DLBCL) who delay treatment initiation may experience better outcomes. • Patients starting treatment within one to two weeks of diagnosis showed shorter times to next-line therapy and reduced overall survival. • The research highlights the importance of real-world data in assessing treatment strategies for older DLBCL patients, often underrepresented in trials. • The study also found that patients who initiated treatment immediately were more likely to have high-risk clinical features and be treated in academic centers.

Incyte Halts Urticaria Drug Trial After Toxicology Findings, Scraps Liver Disease Program

6 months ago

• Incyte paused enrollment for INCB000262, a drug being tested for chronic urticaria, due to concerning toxicology results from an animal study. • The company discontinued development of INCB000547 after Phase 2 results showed it was ineffective for treating itching associated with liver disease. • These setbacks impact Incyte's strategy to diversify beyond its top-selling drug, Jakafi, and could affect a potential $1.8 billion revenue opportunity. • Despite these challenges, Incyte anticipates Phase 3 results for povorcitinib in hidradenitis suppurativa next year, which remains a key focus.

FDA Approves Incyte and Syndax's Niktimvo for Chronic Graft-versus-Host Disease

9 months ago

• The FDA has approved Niktimvo, developed by Incyte and Syndax Pharmaceuticals, for treating chronic graft-versus-host disease (cGVHD). • Niktimvo is intended for adult and pediatric patients (weighing at least 88.2 pounds) who have failed at least two prior systemic therapies. • Clinical trials showed a 75% response rate within the first six months, with 60% of responders remaining alive and treatment-free for at least a year. • Incyte anticipates Niktimvo could potentially replace or be combined with Jakafi, with projected sales of $650 million.

Tafasitamab Regimen Shows Promise in Improving PFS for Advanced Follicular Lymphoma Patients

9 months ago

A recent phase 3 trial demonstrates that adding tafasitamab-cxix to lenalidomide and rituximab significantly improves progression-free survival (PFS) in patients with relapsed or refractory follicular lymphoma, with no new safety concerns reported.

Drug Development Updates