China “Breakthrough” status for Hutchmed’s Orpathys and Tagrisso combo

Chinese biopharma Hutchmed (LON: HCM) today announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy designation (BTD) for the combination of its Orpathys (savolitinib) and AstraZeneca’s (LSE: AZN) Tagrisso (osimertinib).

The combo therapy is for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation‑positive non‑small cell lung cancer (NSCLC) with MET amplification after disease progression on EGFR inhibitor therapy.

Hutchmed noted that this treatment combination is being evaluated in China in the ongoing multicenter, open-label, randomized, controlled, Phase III SACHI trial. The study is investigating the efficacy and safety of a combination of Orpathys and Tagrisso compared to platinum-based doublet-chemotherapy (pemetrexed plus cisplatin or carboplatin), the standard‑of‑care treatment option, in patients with locally advanced or metastatic NSCLC with MET amplification after failure of EGFR inhibitor therapy.