HUTCHMED/AstraZeneca's Savolitinib Granted Breakthrough Therapy Designation for MET-Amplified Gastric or Gastroesophageal Junction Adenocarcinoma

On August 17, the CDE website showed that the savolitinib tablet of Hutchison MediPharma Co., Ltd. ("Hutchmed") was proposed to be included in the breakthrough therapy designation for the indication: locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET gene amplification that failed at least two lines of standard treatment.

Source of the image: CDE official website

Savolitinib (Volitinib) is the first selective MET inhibitor in China, with AstraZeneca responsible for commercialization both domestically and internationally. MET is a receptor tyrosine kinase that exhibits dysfunction in many types of solid tumors, playing roles that include promoting tumor growth, angiogenesis, and metastasis. As a highly selective oral MET inhibitor, savolitinib is widely used in the clinical development for patient populations with MET-driven lung cancer, gastric cancer, and papillary renal cell carcinoma.

In June 2021, Savolitinib was approved for the treatment of non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations, becoming the first selective MET inhibitor approved in China and the third MET inhibitor approved globally.

In addition to METex14 skipping mutations, for MET amplification, EGFR mutations, and second/third-line treatment of osimertinib-resistant NSCLC patients, Hutchison MediPharma Co., Ltd. is conducting two global Phase III clinical trials of savolitinib combined with osimertinib (third-generation EGFR-TKI, Tagrisso).

According to the data released at the 2022 World Conference on Lung Cancer (WCLC2022), in patients with high MET abnormal levels (n=108, incidence rate 34%), the ORR was 49%, and the mPFS was 7.1 months. In the subgroup of patients without a history of chemotherapy (n=87), the ORR was 52%, and the mPFS reached 7.2 months. The treatment effect was significantly better than that in patients with low MET abnormal levels (ORR=10%, mPFS=2.8 months).

In addition, Hutchison MediPharma has a broad layout in the field of solid tumor and hematological tumor treatment. Currently, 13 products have entered the clinical stage. Apart from Savolitinib, two innovative anti-tumor drugs have been launched in China: Aiyoute (Fruquintinib) and Soteda (Surufatinib).

In 2022, the market sales of Savolitinib reached 41.2 million US dollars (+159%). Recently, Hutchison MediPharma Co., Ltd. released its semi-annual report for 2023, showing that the market sales of Savolitinib in the first half of the year were 22 million US dollars, a year-on-year decrease of 5% (an increase of 2% at constant exchange rates). Continuous expansion of the indications range may help increase the sales volume of Savolitinib.

Editorial Responsibility: Mu Mian

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