BGB-1663
- Generic Name
- BGB-1663
BeiGene to Present Extensive Hematology Data at EHA 2025, Showcasing BRUKINSA and Next-Generation Therapies
• BeiGene will present 31 abstracts at the European Hematology Association Congress in Milan, highlighting data from its BTK inhibitor BRUKINSA and investigational pipeline assets sonrotoclax and BGB-16673.
• The company's next-generation pipeline assets have demonstrated promising clinical activity and safety profiles across multiple B-cell malignancies, with over 2,500 patients enrolled globally in clinical trials.
• Four oral presentations will feature updated results from clinical studies of BGB-16673 in CLL/SLL and WM, as well as sonrotoclax in combination with BRUKINSA in R/R CLL/SLL and R/R MCL.
BTK Degraders Show Promise in Pretreated B-Cell Malignancies
• Novel BTK degraders like AC676, NX-5948, and BGB-16673 are under evaluation in phase 1 trials for relapsed/refractory B-cell malignancies, addressing resistance to BTK inhibitors.
• BGB-16673 demonstrated encouraging response rates in follicular lymphoma (50%) and marginal zone lymphoma (67%), with manageable safety profiles in heavily pretreated patients.
• NX-5948 showed a 75.5% objective response rate in relapsed/refractory CLL/SLL, with a tolerable safety profile and ongoing studies planned for pivotal trials in 2025.
• AC676, a novel BTK chimeric degrader, is in phase 1 dose escalation, showing potential for treating B-cell malignancies, including those with central nervous system involvement.
FDA Approves Tevimbra-Chemotherapy Combination for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma
• The FDA has approved BeiGene's Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
• In the pivotal RATIONALE-306 trial, patients treated with Tevimbra plus chemotherapy demonstrated a median overall survival of 16.8 months compared to 9.6 months with chemotherapy alone, representing a 34% reduction in risk of death.
• This marks BeiGene's third FDA approval in less than a year, following previous approvals for Tevimbra in second-line ESCC and first-line gastric/gastroesophageal junction cancers, highlighting the company's expanding oncology portfolio.
Nurix Therapeutics' BTK Degrader Shows Promise in Clinical Trials
Nurix Therapeutics' lead candidate, NX-5948, demonstrates significant potential in treating chronic lymphocytic leukemia and autoimmune diseases, with plans for registrational trials in 2025. Despite challenges, the company's strategic expansion and strong clinical data position it as a potential leader in the BTK degrader market.
BGB-16673 Shows Promise in Relapsed/Refractory CLL/SLL and Waldenström Macroglobulinemia
• BGB-16673, a novel BTK degrader, demonstrates promising efficacy and a tolerable safety profile in heavily pretreated patients with relapsed/refractory CLL/SLL.
• In patients with Waldenström macroglobulinemia, BGB-16673 achieved an objective response rate of 81% in response-evaluable patients.
• The Phase 1 CaDAnCe-101 trial indicates that BGB-16673 is active in patients with BTK inhibitor resistance and Richter transformation.
• Treatment-emergent adverse events were manageable, with neutropenia being the most common, and no atrial fibrillation or major hemorrhage reported in WM patients.
BeiGene's Brukinsa and Novel Assets Show Promise in CLL Treatment at ASH 2024
• BRUKINSA demonstrated a 71% reduction in progression or death risk compared to bendamustine-rituximab in treatment-naïve CLL patients over a 5-year follow-up.
• Sonrotoclax combined with BRUKINSA showed a 99% overall response rate in treatment-naïve CLL, with no progression observed after 1.5 years.
• BGB-16673, a BTK degrader, exhibited a 94% overall response rate in treatment-resistant CLL, highlighting its potential in addressing unmet needs.
Acalabrutinib Plus Venetoclax Significantly Improves PFS in Untreated CLL
• 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.
Follicular Lymphoma Pipeline Shows Promise with Over 55 Therapies in Development
• The follicular lymphoma treatment landscape is evolving, with over 55 therapies in development by more than 50 active pharmaceutical companies.
• Key players like Incyte, AstraZeneca, and Johnson & Johnson are evaluating novel drugs, including CAR-T therapies and targeted agents, to improve patient outcomes.
• Tafasitamab is expected to have a supplemental Biologics License Application filed in August 2024 for patients who have failed prior therapies.
• Emerging therapies in the pipeline include TQ-B3525, NKTR-255, and Zilovertamab vedotin, targeting various mechanisms to combat follicular lymphoma.
FDA Approvals and Designations in Oncology: September 2024
• The FDA approved a subcutaneous formulation of atezolizumab (Tecentriq Hybreza) for various cancers, offering a more convenient administration option for patients.
• Ribociclib (Kisqali) gained approval for early-stage breast cancer, expanding treatment options for this disease and showing improved invasive disease-free survival.
• Pembrolizumab (Keytruda) in combination with chemotherapy was approved for unresectable advanced or metastatic malignant pleural mesothelioma, improving overall survival.
• Isatuximab (Sarclisa) plus bortezomib, lenalidomide, and dexamethasone was approved for transplant-ineligible, newly diagnosed multiple myeloma patients.
Mantle Cell Lymphoma Pipeline Shows Promise with Novel Targeted Therapies
• The Mantle Cell Lymphoma (MCL) pipeline is robust, featuring over 20 companies developing more than 22 therapies.
• Key players like AbbVie and BeiGene are advancing novel drugs, including BTK inhibitors and Bcl-2 inhibitors, to improve MCL treatment.
• Clinical trials are evaluating promising therapies such as Venetoclax, ADI-001, and Orelabrutinib across various phases.
• Recent data highlights potential for combination therapies and novel mechanisms like BTK degradation in MCL treatment.
September 2024: FDA Actions Span Diabetes, Neurology, and Rare Diseases
• The FDA approved Embecta's tubeless patch pump for insulin delivery in adults with type 1 and type 2 diabetes, offering a 300-unit reservoir based on patient feedback.
• Sparsentan (Filspari) received full FDA approval to slow kidney function decline in adults with primary IgA nephropathy (IgAN), based on positive Phase 3 PROTECT study data.
• Approvals for arimoclomol (Miplyffa) and levacetylleucine (Aqneursa) mark the first specific treatments for neurological symptoms of Niemann-Pick disease type C (NPC).
• Dupilumab (Dupixent) gained approval for COPD, chronic rhinosinusitis with nasal polyps, and was submitted for label expansion for adult growth hormone deficiency.
FDA Grants Fast Track Designation to BGB-16673 for Relapsed/Refractory CLL/SLL
• BGB-16673, an oral BTK-targeting chimeric degradation activation compound, has received FDA Fast Track designation for relapsed/refractory CLL/SLL.
• The designation is based on data from a phase 1/2 study (NCT05006716) evaluating BGB-16673 in B-cell malignancies.
• BGB-16673 may be eligible for accelerated approval and priority review, potentially offering a new treatment option for patients progressing after BTK inhibitors.
Emerging BTK Degraders Show Promise in Treating Resistant B-Cell Malignancies
Recent studies highlight the potential of BTK degraders, such as NX-5948 and BGB-16673, in overcoming resistance in B-cell malignancies. These novel treatments target both resistance mutations and BTK scaffolding activity, showing promising efficacy and safety profiles in early clinical trials.
Drug Development Updates
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