AbbVie Submits Clinical Trial Application in China for Novel SEZ6-Targeting ADC ABBV-706 in Lung Cancer and Other Solid Tumors

Jul 25, 2024 10:00 CST Updated 10:00

AbbVie

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▎Edited by the WuXi AppTec content team

Today (July 25), the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China announced that AbbVie (AbbVie's clinical trial application for ABBV-706 lyophilized powder for injection has been accepted. According to public information,ABBV-706 is aAntibody-Drug Conjugates (ADC) Targeting SEZ6, with a payload of TOP1i, is currently in Phase 1 clinical trials internationally. This is the first time that this SEZ6-targeted ADC candidate has been submitted for clinical trials in China.

Screenshot Source: CDE Official Website

SEZ6 (seizure-related homolog 6), a cell surface protein, is highly specifically expressed in neuroendocrine tumors, including small cell lung cancer and certain neuronal tissues, but shows minimal expression in most normal tissues.ABBV-706 utilizes AbbVie's proprietary novel topoisomerase 1 inhibitor (Top1i) payload.Top1i is an anticancer agent that induces cell death by blocking DNA replication.

In May 2024, AbbVie in ChinaAmerican Society of Clinical Oncology (ASCO) Annual Meeting Oral PresentationResults of the dose escalation for ABBV-706 monotherapy in the first-in-human study in patients with advanced solid tumors. The study enrolled patients with relapsed/refractory small cell lung cancer (SCLC), central nervous system (CNS) tumors, and neuroendocrine neoplasms (NEN). The data showed,For 33 patients evaluable by RECIST,The confirmed objective response rate (ORR) was 21%, with 40% in SCLC patients and 6% in NEN patients.The unconfirmed overall response rate was 45%, with 73% in SCLC patients and 22% in NEN patients.The clinical benefit rate was 91%.The study concluded that ABBV-706 demonstrated manageable safety and favorable efficacy in patients with SCLC and NEN.

According to the data introduced in the press release issued by AbbVie thereafter,Among 48 evaluable patients (23 with SCLC and 25 with NEN), the overall confirmed ORR was 43.8%.。In the SCLC group, the confirmed ORR was 60.9%.。As of the data cutoff, the most common ≥3 TEAEs among all 53 enrolled patients were neutropenia (42%), anemia (42%), and leukopenia (28%).

According to AbbVie's official website pipeline information,ABBV-706A phase 1 clinical study is currently being conducted for non-small cell lung cancer, and in the future, this product is also expected to be used for treating small cell lung cancer, central nervous system tumors, and neuroendocrine carcinoma.

References:
[1]China Drug Clinical Trial Registration and Information Disclosure Platform Official Website. Retrieved Jul 25，2024, From http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml

[2]AbbVie Showcases Robust Solid Tumor Pipeline at ASCO 2024 with New Data from Its Innovative Antibody-Drug Conjugate (ADC) Platform. Retrieved May 28，2024, From https://news.abbvie.com/2024-05-28-AbbVie-Showcases-Robust-Solid-Tumor-Pipeline-at-ASCO-2024-with-New-Data-from-Its-Innovative-Antibody-Drug-Conjugate-ADC-Platform

[3]First-in-human study of ABBV-706, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors.Retrieved May 28 ，2024, From https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3001

[4] AbbVie Official Website. From https://www.abbvie.com/science/pipeline.html.

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