Sunvozertinib
- Generic Name
- Sunvozertinib
- Indication
用于既往经含铂化疗治疗时或治疗后出现疾病进展，或不耐受含铂化疗，并且经检测确认存在表皮生长因子受体（EGFR）20号外显子插入突变的局部晚期或转移性非小细胞肺癌（NSCLC）的成人患者。
Dizal to Present Novel Cancer Therapies DZD8586 and DZD6008 at ASCO 2025
• Dizal's first-in-class LYN/BTK dual inhibitor DZD8586 will be featured in oral and poster presentations for chronic lymphocytic leukemia and diffuse large B-cell lymphoma at ASCO 2025.
• DZD6008, a highly selective EGFR TKI with full blood-brain barrier penetration, will showcase clinical data for EGFR-mutated non-small cell lung cancer patients who have failed third-generation EGFR TKI therapy.
• Both investigational drugs address significant unmet needs: DZD8586 targets both BTK-dependent and independent resistance mechanisms in B-cell lymphomas, while DZD6008 offers potential treatment for NSCLC patients with brain metastases.
Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development
• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development.
• FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer.
• Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.
Golidocitinib Plus PD-1 Antibodies Shows Promise in NSCLC Patients After Anti-PD-1 Therapy Failure
• Dizal's JAK1 inhibitor golidocitinib combined with PD-1 antibodies achieved a 44.3% objective response rate in non-small cell lung cancer patients who progressed on prior anti-PD-1 therapy.
• The combination therapy demonstrated remarkable durability with a median response duration of 20.7 months and a complete response rate of 23.9%, offering potential for patients with limited treatment options.
• Clinical findings will be presented at the 2025 European Lung Cancer Congress, with researchers suggesting the combination may overcome resistance mechanisms through JAK/STAT pathway modulation.
Nivolumab Plus Cisplatin-Radiotherapy Improves Disease-Free Survival in Advanced Head and Neck Cancer
• The Phase 3 NIVOPOSTOP trial demonstrated that adding nivolumab to standard cisplatin-radiotherapy significantly improved disease-free survival (DFS) in patients with resected, locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).
• The study showed a statistically significant and clinically meaningful improvement in DFS for patients receiving nivolumab compared to those receiving cisplatin-radiotherapy alone, marking a potential shift in the standard of care.
• A trend toward improved overall survival (OS) was observed with nivolumab, with final OS analysis pending, and the safety profile of nivolumab was consistent with previous studies.
• The findings suggest that adjuvant nivolumab could be practice-changing for high-risk LA-SCCHN patients, offering a new treatment option after surgery to reduce the risk of relapse.
FDA Grants Priority Review to Sunvozertinib for NSCLC with EGFR Exon 20 Insertions
• The FDA granted priority review to sunvozertinib for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations.
• The application is for patients whose disease progressed after platinum-based chemotherapy, offering a potential new oral treatment option.
• The decision is based on the WU-KONG1 Part B study, which showed statistically significant clinical benefits in relapsed/refractory NSCLC.
• Sunvozertinib has already received accelerated approval in China for the same indication, marking it as a promising treatment worldwide.
RYBREVANT and LAZCLUZE Combination Shows Significant Survival Improvement in EGFR-Mutated NSCLC
• Johnson & Johnson's RYBREVANT plus LAZCLUZE demonstrates statistically significant and clinically meaningful improvement in overall survival (OS) versus osimertinib in EGFR-mutated NSCLC.
• The MARIPOSA Phase 3 study showed the chemotherapy-free combination is expected to improve median OS by over one year compared to the current standard of care.
• RYBREVANT plus LAZCLUZE is approved in the U.S. and Europe as a first-line therapy for NSCLC patients with EGFR exon 19 deletions or L858R substitution mutations.
• The safety profile of the combination was consistent with individual treatments, with venous thromboembolic events managed through prophylactic anticoagulants.
Dizal Seeks FDA Approval for Sunvozertinib in EGFR Exon20ins NSCLC
• Dizal has submitted a New Drug Application (NDA) to the FDA for sunvozertinib, targeting locally advanced or metastatic NSCLC with EGFR exon20 insertion mutations.
• The NDA is supported by the WU-KONG1 Part B trial, which demonstrated a statistically significant and clinically meaningful objective response rate in relapsed or refractory patients.
• Sunvozertinib, an irreversible EGFR inhibitor, has already received accelerated approval in China and breakthrough therapy designations from both the FDA and China's CDE.
• A Phase III trial, WU-KONG28, is underway to compare sunvozertinib with platinum doublet chemotherapies in treatment-naive patients globally.
FDA Considers Sunvozertinib for Pretreated EGFR Exon 20+ NSCLC as Oncology Advances Unfold
• The FDA is reviewing sunvozertinib for non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations after platinum-based chemotherapy.
• Sunvozertinib showed a 53.3% overall response rate in the phase 2 WU-KONG1 trial, offering a potential new treatment option.
• The FDA approved obecabtagene autoleucel for relapsed/refractory B-cell precursor acute lymphoblastic leukemia based on a 42% complete remission rate in the FELIX trial.
Dizal Seeks FDA Approval for Sunvozertinib in EGFR Exon20ins NSCLC
• Dizal has submitted an NDA to the FDA for sunvozertinib to treat NSCLC patients with EGFR exon 20 insertion mutations.
• The application is supported by the WU-KONG1 Part B study, which showed a statistically significant and clinically meaningful objective response rate.
• Sunvozertinib is already approved in China for the same indication, making it the first oral drug for NSCLC patients with EGFR exon20ins.
• The drug has received Breakthrough Therapy Designations from both the US FDA and the China Center for Drug Evaluation.
FDA Filing Accepted for Sunvozertinib in EGFR Exon 20 Insertion-Positive NSCLC
• Dizal's sunvozertinib NDA has been submitted to the FDA for treating NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy.
• The NDA submission is backed by phase 2 WU-KONG1 trial data, which demonstrated a 53.3% overall response rate in patients treated with sunvozertinib.
• The median duration of response was not reached, with a 9-month duration of response rate of 57% observed in the study.
• Sunvozertinib has already been approved in China for similar indications, marking Dizal's first NDA submission to the FDA.
Sunvozertinib NDA Submitted to FDA for EGFR Exon 20+ NSCLC
• Dizal has submitted an NDA to the FDA for sunvozertinib to treat NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy.
• The NDA submission is based on the phase 2 WU-KONG1 trial, which showed a 44.9% confirmed ORR in patients treated with sunvozertinib at 300 mg.
• The median duration of response was not reached, with a 9-month DOR rate of 57% in the sunvozertinib arm.
• Sunvozertinib has already been approved in China for the same indication based on the WU-KONG6 trial data.
FDA Reviewing Sunvozertinib for EGFR Exon 20 Insertion-Mutated NSCLC
• The FDA is reviewing sunvozertinib for relapsed/refractory NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy.
• The application is supported by the phase 2 WU-KONG1 part B study, which showed a 54.3% overall response rate.
• Sunvozertinib, an oral single agent, has demonstrated a manageable safety profile, with mostly grade 1 or 2 adverse events.
• Sunvozertinib has already been approved in China and was granted breakthrough therapy designation by the FDA in April 2024.
Dizal Submits NDA to FDA for Sunvozertinib in EGFR Exon20ins NSCLC
• Dizal has submitted an NDA to the FDA for sunvozertinib to treat NSCLC patients with EGFR exon 20 insertion mutations after platinum-based chemotherapy.
• The application is supported by the WU-KONG1 Part B study, which showed statistically significant and clinically meaningful objective response rate (ORR).
• Sunvozertinib is an irreversible EGFR inhibitor and has already received accelerated approval in China for the same indication.
• Ongoing global pivotal studies are evaluating sunvozertinib in both 1st and 2nd line settings for NSCLC patients with EGFR exon20ins.
Dizal Submits NDA to FDA for Sunvozertinib in EGFR Exon20ins NSCLC
• Dizal has submitted an NDA to the FDA for sunvozertinib to treat NSCLC patients with EGFR exon 20 insertion mutations after platinum-based chemotherapy.
• The application is based on the pivotal WU-KONG1 Part B study, which showed statistically significant and clinically meaningful objective response rate (ORR).
• Sunvozertinib is already approved in China for the same indication, making it the first and only oral drug for NSCLC patients with EGFR exon20ins.
• The drug has received Breakthrough Therapy Designations from both the U.S. FDA and China's CDE for treating EGFR exon20ins NSCLC.
Dizal Submits FDA Application for Sunvozertinib in EGFR Exon20ins NSCLC
• Dizal has submitted a New Drug Application (NDA) to the U.S. FDA for sunvozertinib to treat NSCLC with EGFR exon 20 insertion mutations.
• The application is supported by the pivotal WU-KONG1 Part B study, which showed statistically significant and clinically meaningful objective response rates.
• Sunvozertinib is already approved in China as the first oral drug for NSCLC patients with EGFR exon20ins and has Breakthrough Therapy Designations from the FDA and CDE.
• The drug's novel molecular structure enhances efficacy, safety, and ease of administration for patients with this difficult-to-treat form of lung cancer.
Dizal Submits NDA to FDA for Sunvozertinib in EGFR Exon20ins NSCLC
• Dizal has submitted a New Drug Application (NDA) to the FDA for sunvozertinib, targeting non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
• The NDA is supported by the WU-KONG1 Part B study, which demonstrated a statistically significant and clinically meaningful objective response rate (ORR) in relapsed or refractory patients.
• Sunvozertinib has already received accelerated approval in China for the same indication and Breakthrough Therapy Designations from both the U.S. FDA and China's CDE.
• Lung cancer, with NSCLC representing 80-85% of cases, poses a significant global health challenge, and EGFR exon20ins mutations are associated with poorer prognosis.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
China CDE Grants Breakthrough Therapy Designation to Sunvozertinib for First-Line EGFR Exon20ins NSCLC
• Sunvozertinib receives Breakthrough Therapy Designation (BTD) from China's CDE for first-line treatment of NSCLC with EGFR exon 20 insertion mutations.
• The designation marks the fourth BTD for sunvozertinib in EGFR exon20ins NSCLC, following a similar grant from the U.S. FDA.
• Clinical data from WU-KONG1 and WU-KONG15 trials demonstrated a 78.6% confirmed objective response rate and 12.4 months median progression-free survival.
• Sunvozertinib is currently being evaluated in the Phase III WU-KONG28 study, comparing it to platinum doublet chemotherapies in treatment-naive patients.
NMPA Approves First NGS-Based Companion Diagnostic for Lung Cancer with Sunvozertinib
• The NMPA has approved the first co-developed NGS-based companion diagnostic (CDx) for lung cancer in China, LungCure CDx, developed by Burning Rock and Dizal.
• LungCure CDx is designed to identify EGFR exon 20 insertion mutations in NSCLC patients, guiding the use of Dizal's targeted therapy, sunvozertinib.
• Sunvozertinib, an irreversible EGFR inhibitor, has already received approval in China for advanced NSCLC patients with EGFR exon20ins mutations after platinum-based chemotherapy.
• This approval marks a significant step in precision oncology, providing a comprehensive diagnostic and therapeutic solution for NSCLC patients with specific EGFR mutations.
Sunvozertinib Granted FDA Breakthrough Therapy Designation for First-Line EGFR Exon 20 Insertion-Positive NSCLC
• The FDA has granted Breakthrough Therapy Designation to sunvozertinib for first-line treatment of advanced NSCLC with EGFR exon 20 insertion mutations.
• The designation is based on Phase I/II WU-KONG1 trial results, which showed a 78.6% objective response rate and 12.4 months median progression-free survival.
• Sunvozertinib, an oral EGFR inhibitor, has demonstrated significant clinical benefits and a manageable safety profile in multiple clinical trials.
• Dizal anticipates submitting New Drug Applications to the US and EU for sunvozertinib in relapsed/refractory NSCLC later in 2024.
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