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.
Year: 2024
Type: conference-abstract
Abstract: 8513 Background: A multinational pivotal study WU-KONG1 (NCT03974022) has been conducted to assess sunvozertinib (DZD9008) in pre-treated non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations (exon20ins). Here we report the results of primary analysis. Methods: WU-KONG1 Part B is a phase 2, multinational pivotal study to assess the antitumor efficacy of sunvozertinib at two dose levels, 200 mg and 300 mg, in platinum pre-treated NSCLC patients with EGFR exon20ins. Eligible patients were randomized at the ratio of 1:1 to receive 200 mg or 300 mg sunvozertinib once daily until discontinuation criteria were met. Randomization was stratified by brain metastasis at baseline and number of regimens of prior systemic anti-cancer therapy. The primary endpoint was Independent Review Committee (IRC) assessed objective response rate (ORR) (per RECIST v1.1) and key secondary endpoint included IRC assessed duration of response (DoR). Results: As of January 4, 2024, a total of 184 patients were randomized to receive sunvozertinib treatment at 200 mg or 300 mg. Patients who met the predefined criteria for efficacy analysis were included in the primary analysis. The majority of patients (96.0%) had metastatic diseases, 60.7% had ECOG PS of 1, and 23.7% had baseline brain metastasis. All patients received prior platinum-based chemotherapy for advanced NSCLC, and 43.4% and 13.3% had prior onco-immunotherapy or amivantamab treatment. Per IRC assessment, the best ORR was 54.3% (41.0% confirmed and 5.8% pending confirmation). Confirmed complete response (CR) was achieved in 2.9% patients. The disease control rate (including CR, PR and stable disease) was 90.8%. The primary endpoint met its predefined target, with statistical significance. Tumor response was observed in patients with baseline brain metastasis, different demographics and EGFR exon20ins subtypes. With median follow-up time of 5.5 months for responders, the duration of response has not been reached, with 74.6% responders still responding. The PFS data are not mature with approximately 6-month follow-up. Safety findings were similar to previously reported results of sunvozertinib in other clinical studies. The most common drug-related TEAEs included diarrhea, skin rash and CPK increase. The majority of the TEAEs were CTCAE grade 1 or 2 and clinically manageable. Conclusions: 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. Clinical trial information: NCT03974022 .
Source: Journal of Clinical Oncology
Authors: James Chih-Hsin Yang, Ludovic Doucet, Mengzhao Wang, Yun Fan, Meili Sun, Laurent Greillier, David Planchard, Julien Mazieres, Enriqueta Felip, Bruna Pellini, Joaquim Bosch-Barrera, Manuel Cobo, Alessandra Bearz, Luis G. Paz-Ares, Lyudmila Bazhenova, Elaine Shum, Marcello Tiseo, Hector Soto Parra, Li Zheng, Pasi A. Janne
Institutions: National Taiwan University, National Taiwan University Hospital, Institut de Cancérologie de l'Ouest, Chinese Academy of Medical Sciences & Peking Union Medical College, Peking Union Medical College Hospital, Zhejiang Cancer Hospital, Jinan Central Hospital, Aix-Marseille Université, Assistance Publique Hôpitaux de Marseille, Institut Gustave Roussy, Centre Hospitalier Universitaire de Toulouse, Hôpital Larrey, Vall d'Hebron Hospital Universitari, Vall d'Hebron Institute of Oncology, Moffitt Cancer Center, Institut Català d'Oncologia, Hospital Universitari de Girona Doctor Josep Trueta, Hospital Regional Universitario de Málaga, Centro di Riferimento Oncologico, Universidad Complutense de Madrid, Hospital Universitario 12 De Octubre, University of California San Diego, Moores Cancer Center, NYU Langone Health, NYU Langone’s Laura and Isaac Perlmutter Cancer Center, Ospedale di Parma, Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco", Dizal (Jiangsu) Pharmaceutical Co., Ltd. (China), Dana-Farber Cancer Institute
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4400036641