Zegfrovy (sunvozertinib) / Dizal Pharma - LARVOL DELTA

Genetic modulation of ABCB1: Sunvozertinib reverses ABCB1-mediated multidrug resistance in cancer cells. (PubMed, Cancer Genet) - "Furthermore, treatment with sunvozertinib did not change protein expression or subcellular localization of ABCB1. Altogether, these data demonstrate that sunvozertinib, when combined with other conventional chemotherapeutic agents, can overcome MDR and improve therapeutic effect."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ABCB1 • ABCC1 • ABCG2 • EGFR

Sunvozertinib in EGFR exon 20 insertion-mutated non-small cell lung cancer: expanding targeted therapy beyond standard EGFR inhibitors: a correspondence. (PubMed, Ann Med Surg (Lond)) - No abstract available

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

Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation. (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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: Jul 2025 ➔ Dec 2025

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

Sunvozertinib (Zegfrovy): an oral EGFR inhibitor that irreversibly targets exon20ins in NSCLC. (PubMed, Trends Pharmacol Sci) - No abstract available

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

Sunvozertinib: a Promising Oral EGFR Inhibitor Approved for NSCLC with EGFR Ex20ins Mutations. (PubMed, Invest New Drugs) - "Conventional EGFR-TKIs exhibited minimal clinical efficacy, primarily due to intrinsic structural resistance mechanisms conferred by these specific mutations. This manuscript focuses on the clinical studies that supported the USFDA accelerated approval of sunvozertinib, along with its ongoing and upcoming clinical trials, preclinical research, and other pharmacological aspects."

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

Case Report: A Rare EGFR 20 Insertion Variant, P772_H773insGNP Mediates Resistance to Sunvozertinib but Is Sensitive to Furmonertinib. (PubMed, Cancer Manag Res) - "EGFR exon 20ins mutations are highly heterogeneous, and different subtypes exhibit varying sensitivities to targeted drugs. Exploring individualized treatment approaches is of great clinical importance."

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

A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28) (clinicaltrials.gov) - P3 | N=324 | Active, not recruiting | Sponsor: Dizal Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Sunvozertinib Monotherapy in Advanced Lung Adenocarcinoma with EGFR Exon 20 Insertion and High PD-L1 Expression: A Case Report. (PubMed, Cancer Manag Res) - "This regimen yielded a prolonged progression-free survival, with manageable safety and tolerability profiles. These findings demonstrated that sunvozertinib could be a promising first-line treatment option for NSCLC patients with EGFR exon 20 insertion."

IO biomarker • Journal • Monotherapy • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

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 | Not yet recruiting | Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd.

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Adjuvant Therapy With Furmonertinib Significantly Reduces the Recurrence Rate in Lung Cancer Patients With Exon 20 Insertion Mutations (IASLC-WCLC 2025) - "All patients received adjuvant therapy with Furmonertinib after surgery(One of the patients switched to Sunvozertinib after one year of Furmonertinib treatment). Conclusions : This case series highlights the potential of Furmonertinib as an effective adjuvant therapy in reducing recurrence rates in NSCLC patients with exon 20 insertion mutations. Further prospective studies are warranted to confirm these findings and to better understand the long-term efficacy and safety of Furmonertinib in this population."

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

Persistent Response of Sunvozertinib in Lung Adenocarcinoma Patient With EGFR Exon 20 Insertion Mutation (IASLC-WCLC 2025) - "From March 2022, the treatment of tislelizumab, pemetrexed and carboplatin was given every 3 weeks for 6 cycles. By March 2025, the patient's progression-free survival reached 36 months. Conclusions : For lung adenocarcinoma patient with EGFR exon20ins mutation, sunvozertinib showed sustained efficacy and safety benefits as first-line maintenance treatment after the patient developing intolerance to immunotherapy and chemotherapy."

Clinical • EGFR exon 20 • IO biomarker • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

Efficacy of Sunvozertinib in Advanced NSCLC With HER2 Exon 20 Insertion After Prior Treatment Failure: A Real-World Case Series (IASLC-WCLC 2025) - "Prior treatments included first-line chemotherapy plus immunotherapy (PFS 3 months) and second-line dacomitinib (PFS 4 months)...Subsequent sunvozertinib plus vinorelbine yielded stable disease (SD) for 1 month, followed by progression after 2 months...The AE profile (rash, diarrhea, mucositis) was tolerable and manageable. These real-world data suggest sunvozertinib as a promising option for this population, meriting further prospective research."

Clinical • HER2 exon 20 • IO biomarker • Metastases • Real-world • Real-world evidence • Anorexia • Lung Adenocarcinoma • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Solid Tumor • Stomatitis • EGFR • HER-2

Long Progression-Free Survival With Sunvozertinib in EGFRm NSCLC Patients After Third-Generation EGFR TKI Failure: Case Series (IASLC-WCLC 2025) - "After relapsing in Jun 2010, he received various chemotherapy regimens until Aug 2012, followed by icotinib, then osimertinib (found T790M mutation) was administered as fifth-line therapy (Dec 2017-May 2023) combined with anlotinib from 2020, and nab-paclitaxel plus sugemalimab as sixth-line (May-Oct 2023). For seventh-line treatment, sunvozertinib 150 mg QD with vinorelbine maintained for over 12 months...After relapsing in 2016, she received gefitinib...Table 1. Case summary (Data cutoff: Dec 11, 2024)"

Clinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Adjuvant Sunvozertinib for Early-Stage NSCLC Patients With EGFR Exon 20 Insertion Mutation: A Case Series (IASLC-WCLC 2025) - "Adjuvant treatment with sunvozertinib helped these patients pass the 1-year peak period of disease recurrence successfully. Prospective studies of sunvozertinib in early-stage NSCLC patients are worth further investigation."

Clinical • EGFR exon 20 • Lung Adenocarcinoma • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Solid Tumor • Stomatitis • EGFR

Neoadjuvant Sunvozertinib for Early-Stage NSCLC Patients With EGFR Exon 20 Insertion Mutation: A Case Series (IASLC-WCLC 2025) - "In addition, the safety profile was acceptable. Prospective studies with larger sample sizes of sunvozertinib in early-stage NSCLC patients are worth further investigation."

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

A Phase II Study of Sunvozertinib Combined With Chemotherapy in EGFR-TKIs Resistant EGFRm Advanced NSCLC Patients(WU-KONG36) (IASLC-WCLC 2025) - "The initial dosing of Sunvozertinib was 200 mg p.o. daily in combination with pemetrexed plus cisplatin or carboplatin, followed by pemetrexed maintenance and Sunvozertinib 200 mg. Conclusions : Sunvozertinib in combination with chemotherapy is well tolerated and has demonstrated encouraging antitumor activity in NSCLC patients with EGFR mutations who failed prior EGFR-TKIs therapies. Enrollment is currently ongoing and results will be updated in the meeting."

Clinical • Metastases • P2 data • Anemia • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

A Phase II Study of Sunvozertinib Combined With Anlotinib in NSCLC Patients Harboring EGFR Ex20Ins and Uncommon EGFR Mutations (IASLC-WCLC 2025) - "Conclusions : Sunvozertinib in combination with anlotinib is well tolerated and has demonstrated encouraging antitumor activity in NSCLC patients with EGFR exon20ins and uncommon EGFR mutations. Enrollment is currently ongoing and results will be updated in the meeting."

Clinical • EGFR exon 20 • P2 data • Cardiovascular • Hepatology • Hypertension • Liver Failure • Lung Cancer • Non Small Cell Lung Cancer • Portal Hypertension • Solid Tumor • EGFR

Resistance Mechanisms of Novel Targeted Therapies to EGFR Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer (IASLC-WCLC 2025) - "Two patients with p.A763_Y764insFQEA who received afatinib therapy developed EGFR T790M as the resistance mechanism. Among 10 patients who received mobocertinib (n = 7), sunvozertinib (n = 2) or furmonertinib (n = 1), baseline EGFR mutations preserved in post-treatment tissue samples in 9 (90%) patients, EGFR amplification was detected in 5 (50%) patients...Conclusions : EGFR amplification is the most common resistance mechanism of novel EGFR inhibitors targeted on EGFR exon 20 insertion mutation. The resistance mechanisms of amivantamab therapy warrant further study."

EGFR exon 20 • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CDK4 • EGFR • MDM2 • MET • MYC

A Phase II Study of Sunvozertinib Combined With Anlotinib in Treatment-Naïve NSCLC With EGFR Sensitive Mutations and Co-Mutations (WU-KONG32) (IASLC-WCLC 2025) - "Conclusions : Sunvozertinib combined with Anlotinib demonstrated promising efficacy and manageable safety in treatment-naïve NSCLC patients with EGFR mutations and co-mutations. This combination therapy holds promise to meet the unmet clinical needs of this population, offering new regimen for patients and warranting further investigation."

P2 data • Anorexia • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • CTNNB1 • EGFR • PIK3CA • TP53

Sunvozertinib Combined With Bevacizumab in Previously Treated Advanced NSCLC With EGFR Exon 20 Insertion Mutations (IASLC-WCLC 2025) - P2 | "No new safety risks were noted compared to individual drugs. Conclusions : Our results demonstrated notable combination effect of sunvozertinib with bevacizumab in pretreated NSCLC with EGFR exon20ins."

EGFR exon 20 • Metastases • Lung Cancer • Non Small Cell Lung Cancer • 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

Real-world cases supported the potential of ZEGFROVY in early- and advanced- stage NSCLC patients with EGFR exon20ins. (PRNewswire) - "As a neoadjuvant therapy, ZEGFROVY showed encouraging clinical benefit, with all 3 patients achieving an obvious partial response (PR) before surgery. (#EP.07.49); In the adjuvant setting, ZEGFROVY showed sustained efficacy and tolerable safety profiles, helping patients successfully pass the 1-year after surgery, a peak period for disease recurrence (#EP.07.55); In the first-line maintenance setting, ZEGFROVY showed sustained efficacy and safety in lung adenocarcinoma patients who were intolerant to immunotherapy and chemotherapy (#EP.12.47)."

EGFR exon 20 • Real-world • Lung Adenocarcinoma • Non Small Cell Lung Cancer

Sunvozertinib (Zegfrovy) for NSCLC. (PubMed, Med Lett Drugs Ther) - No abstract available

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

In EGFR exon20ins NSCLC, ZEGFROVY demonstrated promising antitumor efficacy and a tolerable safety profile across first- and second- line, as well as adjuvant and neoadjuvant treatment settings. (PRNewswire) - "ZEGFROVY combined with anlotinib achieved an objective response rate (ORR) of over 80% and a disease control rate (DCR) of 100% in treatment-naïve EGFR exon20ins NSCLC (#P3.12.43); In previously treated patients, ZEGFROVY combined with bevacizumab achieved a DCR of 100%, with target tumor lesion shrinkage observed in 85.7% of patients. With a median follow-up of 15.2 months, the median duration of response (DoR) was 19.1 months, and three patients (3/14) remained in response at the data cut-off (#P2.10.13)."

EGFR exon 20 • P2 data • Non Small Cell Lung Cancer