Zegfrovy (sunvozertinib) / Dizal Pharma - LARVOL DELTA

Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B). (PubMed, J Clin Oncol) - P1/2 | "Sunvozertinib is efficacious at both 200 and 300 mg once daily in treating platinum-pretreated patients with advanced EGFR exon20ins NSCLC. The treatment-related adverse events of sunvozertinib were consistent with an EGFR tyrosine kinase inhibitor, with a more favorable safety profile at 200 mg than 300 mg once daily."

Journal • P2 data • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Dizal Announces Positive Topline Phase 3 Results from WU-KONG28 Study: Evaluating Oral, Once-Daily ZEGFROVY (Sunvozertinib) vs. Platinum-Containing Chemo Doublet in First-Line Non-Small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertion Mutation (exon20ins) (PRNewswire) - "Treatment with ZEGFROVY resulted in statistically significant and clinically meaningful improvement in progression free survival (PFS) over platinum-containing chemo doublet. WU-KONG 28 is the first and only phase 3 study to demonstrate meaningful benefits with an oral, once daily, chemo-free, targeted therapy. In addition to improvement in PFS, ZEGFROVY also showed superior results in all secondary endpoints, including cORR, DOR, DCR, compared to platinum-based chemo doublet....Detailed data from the primary analysis will be submitted for presentation at an upcoming international scientific congress."

EGFR exon 20 • P3 data: top line • Non Small Cell Lung Cancer

Clinical outcomes and molecular characterization of patients with uncommon EGFR-mutated NSCLC: A single-centre study (ELCC 2026) - "MPFS for osimertinib (osi) or lazertinib (lazer) monotherapy (n=27), osi + chemotherapy (n=4) and afatinib (n=3) were 10.0 mo (95% CI 6.2–30.3), 9.0 mo (95% CI 4.2–NR) and 16.7 mo (95% CI 12.9–NR), respectively. MPFS was not reached with amivantamab + lazer (n=3), chemotherapy ± immunotherapy (n=6) and zipalertinib (n=1). Progression occurred at 1.5 mo in one patient treated with sunvozertinib.Conclusions This real-world cohort provides broad clinical and molecular characterization of uncommon EGFR-mutated NSCLC and supports the need for dedicated prospective trials."

Clinical • Clinical data • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Efficacy of sunvozertinib in heavily treated patients with EGFR-mutated non-small cell lung cancer: A real-world study (ELCC 2026) - "ORR was 31.0% with 22 partial responses; disease control rate was 71.8%. Median PFS was 3.2 months (95% CI, 2.2–5.2), and median OS was 12.7 months (95% CI, 7.2–16.2).Conclusions Sunvozertinib provides clinical benefit in heavily pretreated EGFR-mutated NSCLC, supporting its role as a later-line treatment option."

Clinical • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Sunvozertinib showed profound antitumor activities as first-line treatment in advanced NSCLC patients harboring P-loop and alpha C-helix compressing (PACC) or other uncommon mutations (ELCC 2026) - P=N/A, P2 | "No new safety signals were observed.Conclusions In the first-line setting, sunvozertinib as monotherapy demonstrated promising anti-tumor efficacy and well-tolerated safety profile in advanced NSCLC patients with EGFR PACC or other uncommon mutations. The updated data will be presented at the meeting."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Multinational Phase 2 Randomized Pivotal Study of Sunvozertinib in Pretreated NSCLC With EGFR Exon 20 Insertion Mutations (IASLC-WCLC 2025) - P1/2 | "Overall, 300 mg once daily showed more favorable clinical outcomes, especially for patients with prior amivantamab treatment or baseline brain metastasis. Detailed data will be presented at the conference."

Clinical • EGFR exon 20 • P2 data • Anemia • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab. (ASCO 2025) - P1/2 | "Of the 51 pts with prior ami, 30 had no other ex20ins-directed therapy, while 21 had also received other ex20ins drugs (such as mobocertinib, sunvozertinib, BLU-451, or poziotinib), the cORR was 30.0% and 14.3%, respectively. Zipalertinib demonstrated clinically meaningful efficacy with a manageable safety profile in pts with exon20ins NSCLC who have received prior platinum-based chemotherapy and for those who received prior amivantamab, a significant and growing unmet need. BICR assessed tumor responses per RECIST v1.1.CR=complete response, PR=partial response, SD=stable disease."

Clinical • EGFR exon 20 • IO biomarker • Anemia • Dental Disorders • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • EGFR

A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1) (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Dizal Pharmaceuticals | N=70 ➔ 140

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Epidermal growth factor receptor tyrosine kinase inhibitor for the treatment of non-small cell lung cancer in the past 30 years (1997-2026). (PubMed, Chin Med J (Engl)) - "Since 1997, EGFR tyrosine kinase inhibitors (EGFR-TKIs) have evolved from first-generation agents, such as gefitinib, erlotinib, and icotinib, to second-generation agents like afatinib and dacomitinib, now to third-generation agents, including osimertinib, aumolertinib, furmonertinib, befotertinib, rezivertinib, rilertinib, limertinib, lazertinib, mifanertinib for EGFR L858R, sunvozertinib for EGFR exon 20 insertion (20ins), and zorifertinib for EGFR-sensitive mutation with brain metastases. Over the past 30 years, substantial advancements have been made in the comprehensive management of EGFR-mutant NSCLC. This systemic review provides the history of the development of EGFR-TKI therapy for NSCLC from 1997 to 2026, highlighting clinical milestones, emerging therapies, and future directions in this rapidly evolving field."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Sunvozertinib A Next-Generation EGFR Exon 20 Insertion Inhibitor Transforming NSCLC Therapy. (PubMed, Zhongguo Ying Yong Sheng Li Xue Za Zhi) - "Recently developed agents such as amivantamab and mobocertinib have improved response rates, yet challenges related to tolerability, CNS penetration, and durability of benefit persist. Early-phase clinical trials, including the WU-KONG series, have reported promising clinical efficacy, including objective response rates ranging from 44-60% in previously treated patients and meaningful activity in treatment-naïve cohorts. The tolerability profile of the drug seems manageable, with diarrhea, rash, and stomatitis among the most commonly observed adverse events; these, however, tend to be milder compared with other agents targeting EGFR Ex20ins."

Journal • Review • Dental Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • EGFR

Personalized treatment of HER2-positive lung adenocarcinoma using Human Organoid Drug Sensitivity Test. (PubMed, Hum Vaccin Immunother) - "The HO results indicated efficacy of Sunvozertinib and ineffectiveness of ADC, with maximum half-maximal inhibitory concentration (IC50) values of 0.28 and 2.96, respectively. This case demonstrates the potential of Human Organoid Drug Sensitivity Test (HO-DST) to guide effective salvage therapy, bridging the gap between genomic profiling and functional drug response in precision oncology."

Journal • Interstitial Lung Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2

Properties of FDA-approved small molecule protein kinase inhibitors: a 2026 update. (PubMed, Pharmacol Res) - "The following ten drugs received FDA approval in 2025 - avutometinib (inhibiting MEK1/2 in serous ovarian carcinomas), defactinib (blocking FAK in low grade serous ovarian carcinomas), delgocitinib (antagonizing the JAK family in hand eczema), mirdametinib (inhibiting MEK1/2 in type I neurofibromatosis), remibrutinib (blocking BTK in chronic spontaneous urticaria), rilzabrutinib (antagonizing BTK in chronic immune thrombocytopenia), sunvozertinib (blocking mutant exon 21 insertion EGFR NSCLC), taletrectinib (inhibiting mutant ROS1 in NSCLC), vimseltinib (blocking CSF1R in tenosynovial giant cell tumors), and zongertinib (antagonizing mutant HER2 in NSCLC). This article summarizes the physicochemical properties of all 94 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 45 of the 94 FDA-approved drugs have a..."

FDA event • Journal • Review • Atopic Dermatitis • Chronic Spontaneous Urticaria • Contact Dermatitis • Dermatology • Genetic Disorders • Giant Cell Tumor of Bone • Hematological Disorders • Immune Thrombocytopenic Purpura • Immunology • Lung Cancer • Neurofibromatosis • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • Tenosynovial Giant Cell Tumor • Thrombocytopenia • Thrombocytopenic Purpura • Urticaria • CSF1R • EGFR • HER-2 • ROS1

Zipalertinib-A Novel Treatment Opportunity for Non-Small Cell Lung Cancers with Exon 20 Insertions and Uncommon EGFR Mutations. (PubMed, Cancers (Basel)) - "The role and the integration of therapies targeting exon20ins or uncommon mutations into the first- and second-line treatment armamentarium for NSCLC patients is not yet fully established, and the therapeutic impact of monotherapies (e.g., sunvozertinib, firmonertinib) versus combinations with standard platinum-based chemotherapy (e.g., zipalertinib, amivantamab) currently still lacks robust evidence to further change the therapeutic landscape for these patients. Therefore, results from the ongoing trials are eagerly awaited and are expected to shed some light on these open questions."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) (clinicaltrials.gov) - P1/2 | N=315 | Active, not recruiting | Sponsor: Dizal Pharmaceuticals | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

Recent FDA-approved kinase inhibitors for cancer therapy in 2025: A comprehensive review and perspectives. (PubMed, EXCLI J) - "The present review paper aims to provide a summary and a critical synthesis of the development, therapeutic potential, and clinical performance of novel of kinase inhibitors in oncology (i.e. zongeritinib, sunvozertinib, vimseltinib, mirdametinib, avutometinib and defactinib), authorized by the US Food and Drug Administration (FDA) in 2025, aiming to highlight both their transformative role and their inherent limitations. See also the graphical abstract(Fig. 1)."

FDA event • Journal • Review • Hematological Disorders • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Genetic biomarker study of sunvozertinib for clinical prognosis and prediction in NSCLC with EGFR exon 20 insertion mutation. (PubMed, Cell Rep Med) - "Acquired EGFR C797S is identified as a potential on-target resistance mutation to sunvozertinib. Finally, efforts are undertaken to investigate therapeutic approaches that aim to overcome the putative acquired resistance to sunvozertinib."

Biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Sunvozertinib in NSCLC Patients with EGFR Exon20 Insertion Mutations (IASLC-NACLC 2022) - P1/2 | "The data suggest sunvozertinib is active in both treatment naïve and prior platinum-based chemo treated NSCLC patients with EGFR Exon20ins. as well as in patients with CNS metastasis. Two pivotal studies (NCT03974022 and China CTR20211009) are ongoing and the updated data will be presented at the meeting."

Clinical • EGFR exon 20 • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Sunvozertinib for the treatment of NSCLC with EGFR Exon20 insertion mutations: The first pivotal study results. (ASCO 2023) - P1/2, P2 | "The first pivotal study results confirmed sunvozertinib’s superior anti-tumor efficacy than the current available therapy for NSCLC with EGFR exon20ins. The safety profile from WU-KONG6 study was consistent with previously reported findings. The updated data will be presented at the meeting."

EGFR exon 20 • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Sunvozertinib as first-line treatment in NSCLC patients with EGFR Exon20 insertion mutations (ESMO 2023) - P=N/A, P1/2, P2, P3 | "Conclusions In the 1st line setting, sunvozertinib as monotherapy demonstrated promising anti-tumor efficacy and acceptable safety profile in NSCLC patients with EGFR exon20ins. A phase III, multinational, randomized study (WU-KONG28, NCT05668988) is ongoing to compare sunvozertinib to chemotherapy as 1st line treatment for EGFR exon20ins NSCLC."

Clinical • EGFR exon 20 • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: Primary analysis of WU-KONG1 study. (ASCO 2024) - P1/2 | "All patients received prior platinum-based chemotherapy for advanced NSCLC, and 43.4% and 13.3% had prior onco-immunotherapy or amivantamab treatment. In this primary analysis of WU-KONG1 multinational pivotal study, sunvozertinib demonstrated promising antitumor efficacy in platinum pre-treated NSCLC with EGFR exon20ins, with a tolerable safety profile. The updated data will be presented at the meeting."

EGFR exon 20 • IO biomarker • Dermatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and safety of later-line targeted therapies in advanced non-small cell lung cancer with EGFR exon 20 insertion mutations: a systematic review. (PubMed, Front Pharmacol) - "Recent developments in targeted therapies, including agents such as amivantamab, mobocertinib, and sunvozertinib, have shown promise in patients with pretreated ex20ins-positive NSCLC. No amendments were made to the registered protocol after commencement of the review. The full review protocol can be accessed on the PROSPERO database (Registration number: CRD420251056825)."

IO biomarker • Journal • Review • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Phase II Clinical Trial of DZD9008 in Combination With AZD4205 in Standard Treatment Failed NSCLC Patients With EGFR Mutations (WU-KONG21) (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Dizal Pharmaceuticals | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8) (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

SUM-NSCLC-01: Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations (clinicaltrials.gov) - P2 | N=34 | Recruiting | Sponsor: Fudan University | N=14 ➔ 34

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor