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Haihe Biopharma Presented latest studies of MET Inhibitor SCC244 in NSCLC at ESMO ASIA Congress 2022

December 2, 2022, Shanghai, China---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 its highly selective MET inhibitor SCC244 were presented at ESMO ASIA Congress 2022. The meeting is held in Singapore, during December 2 to 4, 2022.

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Title:SCC244 plus Osimertinib in Patients with Stage IIIB/IIIC or IV, EGFR TKI resistant EGFR-mutant NSCLC Harboring MET Amplification
Report NO.: 607
Report Time: 2022-12-03 09:10-09:15
Presenter: Yongfeng Yu

MET Amplification (METamp) commonly mediates resistance to EGFR Tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC) patients with EGFR mutation1-3. Several clinical trials showed that the combination of MET inhibition with EGFR TKI is a promising therapeutic strategy to overcome the MET amplification-mediated resistance4-6. SCC244 is a highly selective small molecular inhibitor of MET kinase. It was well tolerated and has shown favorable anti-tumor activities in patients with MET aberration as monotherapy in clinical studies.7,8 The open-label Phase Ib/II study (NCT: 04338243) was designed to evaluate the safety and efficacy of SCC244 combined with osimertinib in patients with locally advanced or metastatic EGFR-mutant NSCLC, which carries METamp and was resistant to EGFR TKI. 30 patients received combined treatment of SCC244 and Osimertinib. Overall, ORR was 60% [95% CI:40.6, 77.3], median DOR was 5.8 months [95% CI:3.9, 12.7], median PFS was 6.9 months [95% CI: 3.9, 8.9], and median OS was 16.9 months [95% CI:11.1, NE]. Among 19 patients with EGFR-mutant, T790M negative NSCLC who progressed on 1st or 2nd generation EGFR TKI, ORR was 73.7% [95% CI: 48.8, 90.9], median DOR was 6.2 months [95% CI: 3.3, NE], median PFS was 7.0 months [95% CI: 4.1, 13.8] and median OS was 15.1 months [95% CI:9.5, NE ]. The most common AE was Oedema (70.0%). The most common grade ≥3 treatment related adverse events (TRAE) were thrombocytopenia (16.7%) and neutropenia (16.7%). 6 patients discontinued due to TRAEs, none were solely attributed to SCC244. SCC244 plus osimertinib demonstrated clinical activity in EGFR-mutant NSCLC patients with METamp who are resistant to EGFR TKI. The safety profile was acceptable and manageable.

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Title:A Pooled Analysis of MET TKI SCC244 in NSCLC Patients with MET Overexpression
Poster NO.:688

The prevalence of MET overexpression in NSCLC patients varied from 5% to 75%9 and it may be concurrent with MET amplification. Several studies demonstrated that MET overexpression was an independent factor for poor prognosis among EGFR wild-type NSCLC patients and may be a potential therapeutic target in NSCLC patients10-11.

The purpose of the study was to evaluate the efficacy of SCC244 in locally advanced or metastatic NSCLC patients with MET overexpression. The pooled analysis was performed on the efficacy data from two ongoing single-arm phase Ib studies (NCT03457532 and NCT04270591) of SCC244 in locally advanced or metastatic NSCLC patients. Only NSCLC patients with MET overexpression (IHC≥3+ as determined by central laboratory) not carrying METex14 skipping or EGFR mutation and with no EGFR-TKI inhibitor treatment were included in the analysis.

A total of 32 NSCLC patients were included in the analysis,including 12 treatment naïve patients who either refused or were unsuitable for chemotherapy, and 20 pre-treated patients who received ≥1 lines of prior systemic anti-tumor therapies. The result show that overall ORR was 37.5% (95% CI: 21.1, 56.3), 41.7% (95% CI: 15.2, 72.3) and 35.0% (95% CI: 15.4, 59.2) in treatment naïve and pre-treated patients, respectively. In the 32 patients, median DoR was 8.3 months (95% CI: 2.8, NE), median PFS was 6.9 months (95% CI: 3.6, 9.7), and median OS was 16.2 months (95% CI: 10.3, NE).

In this pooled analysis, SCC244 showed promising antitumor activity in patients with locally advanced or metastatic NSCLC with MET overexpression not carrying METex14 skipping or EGFR mutation. The preliminary efficacy result is favorable in comparison with standard chemotherapy in pre-treated patients. Further large-scale prospective studies are warranted to confirm these findings.

Dr. Ruiping Dong, Chief Executive Officer of Haihe Biopharma, stated,
“Lung cancer has the highest morbidity and mortality among malignant tumors in China. The therapeutic options are still limited for locally advanced or metastatic NSCLC patients who carries EGFR mutation, MET amplification and are resistant to EGFR TKI, or who carries MET overexpression and are negative of known driver-genes. We are pleased to see the primary results of two studies of SCC244 being presented at ESMO ASIA Congress 2022. We would like to thank all the patients, physicians and operation staff in this trial for their great effort. This is the second time that SCC244 has topped the international stage in lung cancer related clinical research. We hope these clinical trials will benefit NSCLC patients as quickly as possible, bringing patients and their families hope for extended benefit.”
Prof. Shun Lu, from the Oncology Department of Shanghai Chest Hospital, commented,
“The results of the clinical studies of SCC244 will have a significant impact on the clinical practice of NSCLC patients in China, Japan and other regions. We are excited to share the latest clinical studies of results from SCC244, a potent and selective small molecular inhibitor of MET kinase, in ESMO ASIA Congress 2022. SCC244 in combination with osimertinib demonstrated excellent clinical efficacy in EGFR TKI-resistant NSCLC patients with MET amplification. In addition, SCC244 monotherapy showed encouraging clinical efficacy in advanced NSCLC patients with MET overexpression. Together with the striking results in the pivotal study of SCC244 for the treatment of NSCLC with METex14 skipping , which was presented at the AACR annual meeting 2022, SCC244 will become new treatment options for NSCLC patients in the future.”
About ESMO ASIA Congress 2022

The European Society for Medical Oncology Asia (ESMO ASIA) Congress 2022 was held in Singapore on Dec. 2-4, 2022. The meeting was sponsored by the European Society for Medical Oncology (ESMO). ESMO ASIA Congress 2022 brings together the most experienced international experts, provides high-level oncology education programs covering all major cancer types, and provides important networking opportunities for international peers, so that oncology professionals in the Asia Pacific region can keep pace with the rapidly evolving science and education of oncology. ESMO ASIA Congress is the result of a strategic collaboration of global and Asian clinicians, a first-class scientific and educational program delivered by top oncology experts from all over the world. The congress is the leading platform in the Asia-Pacific region to discuss the latest data and the latest breakthroughs in oncology, with a focus on regional characteristics.

About SCC244

SCC244 is an oral, potent and highly selective small molecule MET inhibitor. SCC244 has shown excellent pharmacokinetic characteristics,highly effective and durable efficacy and favorable safety profile in NSCLC patients with MET alterations. Compared with its competitors, SCC244 has long half-life to achieve sustained target inhibition, low DDI potential to enable less co-medication restrictions, convenient QD regimen. Haihe Biopharma owns the independent global intellectual property rights of SCC244.

About Haihe Biopharma

Haihe Biopharma is a leading innovation-driven biotechnology company in China focusing on the discovery, development, production and commercialization of innovative anti-tumor drugs. Haihe aims to bring life-saving therapies to cancer patients worldwide. As a new drug R&D company led by an academician of the Chinese Academy of Engineering, Haihe Biopharma is committed to the path of independent innovation. Haihe Biopharma also has a research and management team with global perspectives and is proactively mapping out the international development of its innovative drugs. The Company currently has thirteen drug candidates. As of today, Haihe Biopharma has received 33 IND or clinical trial approvals in four countries.

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