Shanghai, China, April, 7, 2023 -- Shanghai Haihe Biopharma Co., Ltd (referred as "Haihe Biopharma" or the “Company”), a company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, announced that the latest results of pivotal Phase II GLORY study of gumarontinib, an orally potent, highly selective small molecular MET inhibitor, on efficacy and safety in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring MET exon 14 skipping mutation (METex14-positive), has been successfully published in eClinicalMedicine, an internationally renowned medical journal (part of The Lancet Discovery Science, Impact factor 17.033). Prof. Shun Lu is the co-corresponding author.

The results from the GLORY study, an open, international, multicenter, single-arm Phase II study (NCT04270591) showed that the highly selective, potent MET inhibitor gumarontinib had robust and durable clinical activity with manageable toxicity in both treatment naïve and pre-treated patients with locally advanced or metastatic METex14-positive NSCLC.

A total of 84 NSCLC patients were enrolled, and 79 patients with METex14 skipping mutation confirmed by central laboratory were included in the efficacy analysis set, including 44 treatment naïve patients and 35 pre-treated patients.

The overall objective response rate (ORR) assessed by the Blind Independent Imaging Review Committee (BIRC) was 66%, with ORR of 71% in treatment naïve patients and 60% in pre-treated patients. The onset of anti-tumor activity was rapid, and the response in most patients was achieved at the first tumor assessment, with a median time to response of 1.4 months. Median duration of response (mDoR) was 8.3 months in the overall population, 15.0 months in treatment naïve patients, and 8.3 months in pre-treated patients. Median progression-free survival (mPFS) was 8.5 months in the overall population, 11.7 months in treatment naïve patients and 7.6 months in pre-treated patients. The median overall survival (mOS) was 17.3 months in the overall population, which was not reached in treatment naïve patients and 16.2 months in pre-treated patients.

The ORR in patients with brain metastasis was 85%, and encouraging intracranial antitumor effects were also observed. All 5 patients with brain metastasis selected as target lesions by investigator and with post-treatment tumor assessment were observed with intracranial response.

The overall safety is manageable, and the common adverse reaction is edema. These findings further validate METex14 skipping mutations as therapeutic targets in patients with NSCLC, underscoring the importance of routine testing for these mutations, and also support the use of gumarontinib monotherapy in patients with METex14-positive NSCLC.

“Lung cancer is the malignant tumor with the highest morbidity and mortality in China. The available therapies are still limited in China for advanced METex14-positive NSCLC patients. We are very pleased to see the latest results of GLORY study being published in eClinicalMedicine, an international medical journal. We would like to thank all the patients, investigators and operation staff in this trial for their great efforts. Gumarontinib has been approved by NMPA in China in March 2023, and we hope it can benefit a large number of patients.”

 

“The results of the GLORY study will have a significant impact on the precision clinical practice for NSCLC patients in China, Japan and other regions. The GLORY study has demonstrated that gumarontinib (SCC244) has a rapid onset of anti-tumor activity, and compelling efficacyin both treatment naïve and pre-treated METex14-positive NSCLC patients with acceptable safety, and also the great benefits for patients with brain metastases. Now with the approval of gumarontinib, we anticipate that those NSCLC patients with METex14 will be greatly benefited. ”

 

About Gumarontinib

Gumarontinib (code: SCC244) is an oral, potent and highly selective small molecule MET inhibitor. Gumarontinib has shown excellent pharmacokinetic characteristics, highly effective and durable efficacy and favorable safety profile in NSCLC patients with MET alterations. as of today, Compared with its competitors, Gumarontinib has long half-life to achieve sustained target inhibition, low DDI potential to enable less co-medication restrictions, convenient QD regimen. Gumarontinib has been approved by the NMPA in china with breakthrough designation for the treatment of non-small cell lung cancer (NSCLC) with MET genomic aberration.

About Haihe Biopharma Co., Ltd

Haihe Biopharma Co., Ltd is a global, values-based, R&D driven biopharmaceutical leader headquartered in China with operation centers in the US and Japan, and mainly focuses on innovative anti-tumor therapies. The company has the fully capability of drug discovery, development, manufacture and commercialization and delivers life-saving therapies to cancer patients in China, even the world widely. As an R&D focused company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed in-house innovator with global perspective management and R&D team. Currently Haihe Biopharma has one approved product (Gumarontinib) in China and twelve drug candidates and total 33 clinical trials approved by authorities, and has been conducting clinical trials in four major countries.