Savolitinib has been granted a conditional approval in China for use in patients with non–small cell lung cancer with MET exon 14 skipping alterations who experienced disease progression after previous systemic therapy or are unable to receive chemotherapy.
Savolitinib has been granted a conditional approval in China for use in patients with non–small cell lung cancer (NSCLC) with MET exon 14 skipping alterations (METex14) who experienced disease progression after previous systemic therapy or are unable to receive chemotherapy.1
The regulatory decision is supported by data from a phase 2 trial (NCT02897479) done in China that enrolled patients with NSCLC who harbored this mutation, including those with the more aggressive pulmonary sarcomatoid carcinoma (PSC) subtype.2 Data from the study shared during the 2021 ASCO Virtual Scientific Program showed that the agent had encouraging antitumor activity with favorable tolerability in patients with METex14-positive NSCLC.
“It is with great pleasure that today we announce the first regulatory approval of savolitinib globally, HUTCHMED’s third self-discovered oncology drug to be commercialized,” Christian Hogg, chief executive officer of HUTCHMED, stated in a press release. “This approval is a testament to the perseverance and scientific ingenuity of this long-standing alliance, and we are hopeful that this is only the beginning of the progress we can achieve for patients with MET-altered tumors.”
Of 593 Chinese patients who underwent screening for the trial, 87 were found to have METex14 positivity. A total of 70 patients received treatment with savolitinib. The median age of study participants was 68.7 years, 81.4% had an ECOG performance status of 1, and 24.3% had brain metastases. Moreover, 92.9% of patients had stage IV disease, 60% received prior systemic treatment, and 35.7% had PSC.
Data demonstrated that savolitinib elicited a robust and durable tumor response in patients with METex14-positive NSCLC. Specifically, the agent elicited an independent review committee (IRC)–assessed objective response rate of 49.2% in the efficacy evaluable set; this rate was 42.9% in the full analysis set. The benefit observed with savolitinib was reported across the patient subgroups analyzed. Moreover, the duration of response reported with the agent was 9.6 months.
The progression-free survival (PFS) and overall survival (OS) data were not yet mature at the time of the presentation. However, at 50% maturity, the median PFS was 6.9 months, and at 45.7% maturity, the median OS was 14.0 months. The PFS benefit was reported to be of clinical significance in the subgroup of patients with PSC. Moreover, promising benefit was also observed in a subset of patients who had received prior treatment.
The median duration of treatment with savolitinib was 6.8 months. Sixty-two patients were initially given the agent at a once-daily dose of 600 mg, and 8 patients were administered savolitinib at a once-daily dose of 400 mg.
Of the patients included on the trial, 27.5% of patients (n = 18) reported treatment-related serious adverse effects (SAEs); these effects comprised abnormal hepatic function (4.3%), hypersensitivity (2.9%), and pyrexia (2.9%). One participant experienced a treatment-related SAE that was fatal; this was tumor lysis syndrome. Moreover, 14.3% of patients (n = 10) had treatment-related toxicities like drug-induced liver injury and drug hypersensitivity (2.9%) that led to discontinuation.
“This approval makes savolitinib the only targeted medicine approved for these biomarker-selected patients in China, and it adds another novel medicine to our already diverse lung cancer portfolio,” Dave Fredrickson, executive vice president of the Oncology Business Unit of AstraZeneca, added in the release. “We are proud that this first-ever regulatory approval of savolitinib is in China, where we have a long-standing commitment to improving patient outcomes and working with the right partners to achieve that goal.”