肺癌人群广阔，后线进展人群中MET 阳性人群占比较高。肺癌是最高发的癌症类型，每年全球约有240 万人被诊断为肺癌，死亡人数约占所有癌症死亡人数的五分之一。其中最常见的为非小细胞肺癌，占所有肺癌患者的80-85%。美国和欧洲的非小细胞肺癌患者中约有10-25％存在EGFR 突变，而亚洲患者中该比例高达30-40％。MET 是一种受体酪氨酸激酶，MET 扩增或过表达可导致肿瘤生长以及癌细胞的转移进展，且是EGFR 突变的转移性非小细胞肺癌患者对EGFR TKI 治疗产生获得性耐药的主要机制之一。在奥希替尼治疗后疾病进展的患者中，约有15-50% 出现 MET 异常，人群数量可观。Incidents:
Recently, the company announced the positive summary results of the SAVANNAH Phase II study. The combination therapy with Teresa (ositinib) and voracious (sevotinib) showed high, clinically significant, and long-lasting ORR improvements in non-small cell lung cancer patients with EGFR mutations with advanced levels of MET overexpression and/or amplification (defined as IHC90+ and/or FISH10+) after previous treatment with Teresa. The above data will be presented at an upcoming academic conference and shared with global regulators.
Comment:
There are a large number of people with lung cancer, and those who are MET positive account for a relatively high proportion of those who progress laterally. Lung cancer is the most common type of cancer. About 2.4 million people worldwide are diagnosed with lung cancer every year, accounting for about one-fifth of all cancer deaths. The most common of these is non-small cell lung cancer, which accounts for 80 to 85% of all lung cancer patients. EGFR mutations are present in approximately 10-25% of non-small cell lung cancer patients in the US and Europe, while the proportion is as high as 30-40% in Asian patients. MET is a receptor tyrosine kinase. MET amplification or overexpression can lead to tumor growth and progression of cancer cells, and is one of the main mechanisms by which patients with metastatic non-small cell lung cancer with EGFR mutations develop acquired resistance to EGFR TKI treatment. Among patients whose disease progressed after treatment with osimitinib, MET abnormalities occurred in about 15-50%, which is a considerable number.
The clinical results of phase II of the sevotinib combination therapy were positive, showing an improvement in ORR, and it is expected that an NDA will be submitted this year. The SAVANNAH study is an ongoing, randomized, global phase II clinical trial sponsored by AstraZeneca to evaluate Warishah? With Teresa? The efficacy of combination therapy in patients with locally advanced or metastatic non-small cell lung cancer with EGFR mutations, MET amplification, or overexpression of previous disease progression after treatment with Teresa. To date, the study has enrolled more than 360 patients in more than 80 research centers around the world, including North America, Europe, South America, and Asia. The primary end point is ORR. The initial positive ORR results of the SAVANNAH study were announced at the 2022 WCLC conference. Among all patients with high MET levels, the ORR reached 49%. The clinical results announced this time also showed high ORR improvements, and continued to demonstrate the competitiveness of post-line treatment with sevotinib combination therapy. Partner AstraZeneca plans to submit a marketing application to the FDA before the end of the year. It has previously obtained fast-track qualifications. Sevotinib is expected to be approved as the company's second overseas product after fruquintinib, continuing to expand overseas markets.
Profit forecast and investment suggestions: The company has abundant pipeline reserves and broad product market space, and is expected to continue to expand overseas. We expect the company to achieve revenue of $0.729/0.866/1 billion in 24-26, with earnings per share of -0.06/0.05/0.18, maintaining the company's “buy” rating.
Risk warning: risk of R&D falling short of expectations, risk of sales falling short of expectations, policy risk, etc.
