Patients with pulmonary sarcomatoid carcinoma who administered savolitinib daily saw tumor response rates between 42.9% and 49.2%, according to the results of a study published in The Lancet Respiratory Medicine.
This multicenter, single-arm, open-label, phase 2 study across 32 hospitals in China recruited participants aged 18 years or older with locally advanced or metastatic METex14-positive pulmonary sarcomatoid carcinoma. Study participants received oral savolitinib once daily. Radiographic tumor evaluation was done at baseline, every 6 weeks during the first year, and every 12 weeks thereafter. The primary endpoint was tumor response rate, while secondary endpoints included evaluation of adverse events.
Among the 84 patients screened for eligibility, 70 met the inclusion and exclusion criteria and were enrolled in the study. In the primary study outcome, the objective response rate was 49.2% in the tumor response evaluable set and 42.9% in the full analysis set at a median follow-up of 17.6 months. All patients reported at least 1 treatment-related adverse event.
Adverse events of grade 3 or more occurred in 46% patients, the most frequent of which was increased aspartate aminotransferase level. One death due to tumor lysis syndrome in a patient with pulmonary sarcomatoid carcinoma was assessed by the investigator to be probably related to savolitinib.
The study authors wrote, “Savolitinib showed promising activity, with an acceptable safety profile, in patients with METex14-positive advanced NSCLC [non-small cell lung cancer], including pulmonary sarcomatoid carcinoma.” They added, “Our results support savolitinib monotherapy as a novel treatment option for this population.”
Disclosure: This clinical trial was supported by the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Lu S, Fang J, Li X, et al. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. Published online June 21, 2021. 2021;S2213-2600(21)00084-9. doi:10.1016/S2213-2600(21)00084-9