According to primary analysis results from the phase 2 WU-KONG1 study, sunvozertinib demonstrated promising anti-tumor efficacy and safety among patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon20ins mutations who had progressed on or after platinum therapy. 

These data were presented by James Chih-Hsin Yang, MD, PhD, National Taiwan University Cancer Center, Taipei, Taiwan, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

In this multinational, pivotal study, 184 patients were randomized on a 1-to-1 basis to receive either 200 mg (n = 73) or 300 mg (n = 111) of sunvozertinib once daily. Stratification was based on presence of baseline brain metastases and number of prior systemic anti-cancer therapies. An interim analysis found 300 mg sunvozertinib to be the optimal recommended phase 2 dose. The primary end point was objective response rate (ORR) as assessed by independent review committee among patients treated with 300 mg of sunvozertinib. Key secondary end points included duration of response (DOR) and safety. 

There were 107 patients included in the analysis of the 300 mg cohort. At the data cutoff point, confirmed ORR was 44.9% with 2 confirmed complete responses and 46 confirmed partial responses (a further 4 partial responses are pending confirmation). The disease control rate was 90.8%. Dr Yang added, “Anti-tumor efficacy was observed regardless of prior amivantimab treatment.” At a follow-up of 5.5 months, median DOR had not been reached with 74.6% of responders still responding. The 9-month DOR rate was 57%. 

The safety profile was, according to Dr Yang, “similar to what has been previously reported in other sunvozertinib clinical studies.” The most common grade ≥3 treatment-related adverse events (experienced by ≥2% of patients) including diarrhea, blood creatine phosphokinase increase, anemia, rash, lipase increase, neutrophil count decrease, hypokalemia, decreased appetite, and asthenia. There were no treatment-related adverse events that lead to death.

As Dr Yang concluded this study “achieved its primary objective, with manageable safety profile in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins.” He added that a phase 3 multinational, randomized study (WU-KONG28) evaluating sunvozertinib vs platinum-based chemotherapy in the first-line setting among patients with NSCLC with EGFR exon20ins is currently ongoing.

Source:

ang JCH, Doucet L, Wang M, et al. A multinational pivotal study of sunvozertinib in platinum pretreated non-small cell lung cancer with EGFR exon 20 insertion mutations: Primary analysis of WU-KONG1 study. Presented at the ASCO Annual Meeting. May 31-June 4, 2024; Chicago, IL. Abstract #8513