HS-20093
- Generic Name
- HS-20093
Durvalumab Shows Breakthrough Results in Limited-Stage Small Cell Lung Cancer Treatment
• Durvalumab demonstrated significant survival benefits as consolidation therapy after chemoradiation in limited-stage small cell lung cancer patients, establishing a potential new standard of care.
• The FDA granted breakthrough therapy designation to durvalumab for limited-stage small cell lung cancer treatment, following compelling data from the phase 3 ADRIATIC trial.
• The ADRIATIC study showed improved progression-free and overall survival with durvalumab, regardless of prior prophylactic cranial irradiation or concurrent chemoradiotherapy use.
FDA Grants Breakthrough Therapy Designation to GSK's Jemperli for Advanced Rectal Cancer
• The FDA granted Breakthrough Therapy Designation to GSK's Jemperli (dostarlimab) for locally advanced dMMR/MSI-H rectal cancer.
• The designation was based on a Phase II trial showing a 100% clinical complete response rate in all 42 patients treated with dostarlimab.
• Jemperli targets the PD-1 receptor and aims to improve the immune system's ability to eradicate cancer cells without traditional treatments.
• The AZUR-1 trial is ongoing to confirm these findings, potentially changing the treatment paradigm for this subset of rectal cancer patients.
GSK's GSK'227 Receives FDA Breakthrough Therapy Designation for Relapsed Osteosarcoma
• The FDA granted Breakthrough Therapy Designation to GSK'227 for relapsed or refractory osteosarcoma after two prior lines of therapy.
• The designation aims to expedite the development of GSK'227, a B7-H3-targeted antibody-drug conjugate, for this rare bone cancer.
• The FDA's decision was based on promising data from the ARTEMIS-002 trial, which evaluated GSK'227 in osteosarcoma patients.
• GSK'227 represents a potential new treatment option for osteosarcoma patients with limited alternatives after chemotherapy failure.
HS-20093 (GSK'227) Receives FDA and EMA Designations for Osteosarcoma and SCLC
• HS-20093/GSK'227, a B7-H3-targeted ADC, has been granted FDA Breakthrough Therapy Designation for relapsed or refractory osteosarcoma after two prior lines of therapy.
• The EMA has granted PRIME designation to HS-20093/GSK'227 for relapsed extensive-stage small-cell lung cancer (ES-SCLC) based on ARTEMIS-001 study data.
• Osteosarcoma, a rare bone cancer primarily affecting children and young adults, lacks FDA-approved treatments after progression on two prior lines of therapy.
• HS-20093, developed by Hansoh Pharma and licensed to GSK, is undergoing Phase I, II, and III clinical trials for various solid tumors, including lung cancer and sarcoma.
Hansoh Pharma's HS-20093 ADC Granted Breakthrough Therapy Designation for SCLC in China
• Jiangsu Hansoh's HS-20093, a B7-H3-targeted ADC, has received Breakthrough Therapy Designation from China's NMPA for extensive-stage small cell lung cancer (ES-SCLC) following first-line treatment.
• HS-20093 is the first B7-H3-targeted ADC to enter Phase III development in China for second-line SCLC treatment, potentially setting a new standard of care.
• The prevalence of SCLC in China is expected to rise significantly, underscoring the urgent need for innovative treatments like HS-20093 to improve patient outcomes.
• Jiangsu Hansoh is developing two additional ADCs, HS-20089 and HS-20105, for various solid tumors, reinforcing its oncology market position in China.
Hansoh Pharma's HS-20093 ADC Granted Breakthrough Therapy Designation for ES-SCLC
• Hansoh Pharmaceutical's HS-20093, a B7-H3-targeted antibody-drug conjugate (ADC), has received Breakthrough Therapy Designation from China's NMPA.
• The designation targets the treatment of extensive stage small cell lung cancer (ES-SCLC) following standard first-line therapy.
• HS-20093 represents a novel approach to address the unmet needs in ES-SCLC, offering a potential new treatment option.
Hansoh Pharma's HS-20093 Receives Breakthrough Therapy Designation in China for Small Cell Lung Cancer
• Hansoh Pharma's B7-H3-targeted antibody-drug conjugate, HS-20093, has been granted Breakthrough Therapy Designation by China’s National Medical Products Administration.
• The designation is for the treatment of small cell lung cancer (SCLC), a disease with significant unmet medical need.
• This development follows a licensing agreement with GlaxoSmithKline, which is conducting global trials of HS-20093.
• The Breakthrough Therapy Designation could significantly impact Hansoh’s market position and attract investor interest.
GSK Announces Q3 2024 Results: Specialty Medicines Drive Growth, Pipeline Strengthens
• GSK's Q3 2024 sales reached £8.0 billion, with a 2% CER increase, driven by strong performance in Specialty Medicines, offsetting lower Vaccines sales.
• R&D progress includes EU approval for Arexvy in adults aged 50-59 and positive Phase III results for depemokimab in chronic rhinosinusitis with nasal polyps (CRSwNP).
• The company confirms its 2024 guidance, projecting a 7-9% turnover growth and a 10-12% increase in core EPS, excluding COVID-19 solutions.
• A Q3 2024 dividend of 15p per share has been declared, with expectations to declare a 60p per share dividend for the full year.
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.
Immunotherapy Advances Reshape Treatment Landscape for Small Cell Lung Cancer
• Durvalumab consolidation post-chemoradiotherapy significantly improves overall and progression-free survival in limited-stage SCLC, marking a breakthrough in nearly three decades.
• Tarlatamab-dlle, a BiTE therapy, receives accelerated FDA approval for relapsed/refractory extensive-stage SCLC, offering a new treatment option after platinum-based chemotherapy.
• Emerging antibody-drug conjugates like ABBV-706 and GSK5764227 show promise in SCLC treatment, with ongoing trials evaluating their efficacy and safety profiles.
GSK Discontinues Phase III Development of HSV Vaccine Candidate After Phase II Failure
• GSK halts the Phase III development of its herpes simplex virus (HSV) vaccine candidate, GSK3943104, after it failed to meet the primary efficacy objective in the Phase II trial.
• The Phase I/II trial, TH HSV REC-003, assessed the clinical efficacy of GSK3943104 in individuals aged 18-60 years with recurrent genital herpes, but the vaccine did not achieve anticipated efficacy.
• Despite the setback, GSK emphasizes the continued need for innovative treatments for genital herpes and will review data to guide future research and development efforts within its HSV program.
• The TH HSV REC-003 study will continue for routine safety monitoring and to collect follow-up data, which may provide valuable insights into the management of recurrent genital herpes.
GSK's GSK5764227 Receives FDA Breakthrough Therapy Designation for Extensive-Stage Small Cell Lung Cancer
• The FDA granted Breakthrough Therapy Designation to GSK5764227 for extensive-stage small cell lung cancer (ES-SCLC) post-platinum chemotherapy.
• The designation is based on Phase 1 ARTEMIS-001 trial data, showing promising efficacy and manageable toxicity in pretreated solid tumors.
• GSK5764227, a B7-H3-targeted antibody-drug conjugate, showed a 63.6% objective response rate in SCLC patients in the ARTEMIS-001 trial.
• GSK plans to initiate global Phase 1/2 studies in the second half of 2024 to support a registrational pathway for GSK5764227.
GSK Licenses Hansoh Pharma's B7-H3 ADC, HS-20093, for $185 Million Upfront
• GSK has secured an exclusive license for HS-20093, a B7-H3-targeted antibody-drug conjugate (ADC) from Hansoh Pharma, excluding mainland China, Hong Kong, Macau, and Taiwan.
• HS-20093 has demonstrated promising initial clinical activity in lung cancer and other solid tumors, utilizing a clinically validated topoisomerase inhibitor (TOPOi) payload.
• GSK will pay Hansoh Pharma $185 million upfront, with potential for up to $1.525 billion in success-based milestone payments, plus tiered royalties on global net sales.
• GSK plans to initiate Phase I trials for HS-20093 outside of China in 2024, complementing its existing oncology portfolio and capabilities in developing treatments for solid tumors.
GSK's GSK5764227 Receives FDA Breakthrough Therapy Designation for Osteosarcoma
• GSK5764227, a B7-H3-targeted antibody-drug conjugate, has been granted Breakthrough Therapy Designation by the FDA for osteosarcoma treatment.
• The designation aims to accelerate the development and review of GSK5764227 for relapsed or refractory osteosarcoma in adults.
• This is the third regulatory designation for GSK5764227, highlighting its potential in treating serious conditions with limited therapeutic options.
• The FDA's decision is based on preliminary clinical evidence suggesting substantial improvement over existing therapies for bone cancer.
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