Hehuang Pharmaceutical (00013): The combination therapy of Teresa® and Warisha® showed a high and clinically significant remission rate in lung cancer patients with high MET levels in the SAVANNAH phase II study

Zhitong Financial App News, Hehuang Pharmaceutical (00013) today announced the positive summary results of the SAVANNAH Phase II study. Combined treatments with TAGRISSO® (TAGRISSO®, osimertinib) and orpathys® (ORPATHYS®, savolitinib) progressed after previous treatment with Teresa®, accompanied by high levels of mesenchymal epithelial conversion factor overexpression and/or amplification (defined as IHC90+ and/or FISH10+) Patients with non-small cell lung cancer with receptor mutations showed a high, clinically significant, and long-lasting improvement in objective remission rates. The above data will be presented at an upcoming academic conference and shared with global regulators.

In 2023, the combination therapy of Teresa® and Warisha® was granted fast-track status by the US Food and Drug Administration (FDA) for this type of disease.

Vorisha® is a potent and highly selective oral MET tyrosine kinase inhibitor. It was jointly developed by AstraZeneca and Hutchison Pharmaceuticals, and commercialized by AstraZeneca. It has been approved in China to treat patients with non-small cell lung cancer with MET exon 14 jump mutations whose disease progresses after receiving systemic treatment or who are unable to receive chemotherapy.

Although EGFR-targeted therapy can bring significant survival benefits to patients with EGFR mutated non-small cell lung cancer, most patients will eventually become resistant to its treatment, and MET is one of the common biomarkers associated with drug resistance. Among patients enrolled in the SAVANNAH study, it is estimated that 62% of patients had tumors with MET overexpression and/or amplification, and about 34% of patients reached a defined high MET level threshold by the time of clinical progression.

Professor Myung-Ju Ahn of the Department of Internal Medicine and Hematology at Samsung Medical Center, Sungkyunkwan University Medical School in Seoul, South Korea, said, “Ositinib has brought unprecedented survival rates and changed the treatment pattern for lung cancer patients with EGFR mutations, yet patients may develop drug resistance due to genes such as MET (a common biomarker associated with drug resistance). These results suggest that adding the selective MET inhibitor cevotinib in combination with osidinib treatment brings meaningful disease relief to patients with progressive disease, and has the potential to provide a new treatment option after standard therapy with ositinib.”

Susan Galbraith, AstraZeneca's global executive vice president and head of oncology research and development, said, “The positive results of these SAVANNAH studies suggest that targeted therapies can benefit patients with EGFR mutant lung cancer developing MET-driven drug resistance. “On the basis of Teresa®, the pillar therapy for EGFR mutant lung cancer, adding Warisha® in combination can bring about a higher disease remission rate, further emphasizes the importance of identifying MET abnormalities, and verifies the viability of our combined medication strategy to address drug resistance and continue treatment with Teresa®.”

“Early results from the SAVANNAH Phase II study provide an innovative biomarker method to identify patients who are most likely to benefit from MET-oriented treatments with excessive MET expression and/or amplification, a need that has been unmet for a long time,” said Su Weiguo, CEO and Chief Scientific Officer of Chi-Med. “This positive outcome provides a further basis for our patient-centered and selective treatment approach, which promises to be the first biomarker driven targeted drug combination therapy treatment option for such diseases.”

The safety characteristics of Teresa® and Warisha® combination therapy are consistent with the safety of known combination therapies and single drug treatments. No new security issues have been identified.

In August 2022, initial positive ORR results from the SAVANNAH study were presented at the 2022 World Lung Cancer Conference (WCLC) hosted by the International Association for Lung Cancer Research (IASLC).

The SAFFRON Global Phase III study sponsored by AstraZeneca will further evaluate Teresa® and Warisha® combination therapy versus platinum dual-agent chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer patients with EGFR mutations, MET overexpression and/or amplification treated with Teresa®. According to the threshold determined in the SAVANNAH study, patients with high MET levels will be prospectively screened for inclusion in the study.