A targeted medicine called sunvozertinib helped patients with advanced non-small cell lung cancer (NSCLC) containing an EGFR exon 20 insertion mutation live longer without their cancer worsening compared to standard platinum-based chemotherapy in a large international clinical trial. The findings come from the phase 3 WU-KONG28 study, which compared sunvozertinib with carboplatin plus pemetrexed as the first treatment for this specific type of lung cancer.
What the study found
The study included 324 people with advanced NSCLC whose tumors had an EGFR exon 20 insertion mutation. Participants were randomly assigned to take either:
- Sunvozertinib, an oral targeted therapy taken once daily
- Chemotherapy with carboplatin and pemetrexed, given every 3 weeks, followed by pemetrexed maintenance treatment when appropriate
People who started chemotherapy could switch to sunvozertinib if scans confirmed that their cancer had progressed.
Patients who received sunvozertinib had a median progression-free survival of 10.3 months, compared with 7.5 months for those who received chemotherapy. In other words, sunvozertinib reduced the risk of cancer progression or death during the study by 35%.
Tumors also shrank more often with the targeted therapy:
| Outcome | Sunvozertinib | Chemotherapy |
| Patients whose tumors shrank | 58.9% | 31.1% |
| Median duration of tumor response | 11.2 months | 7.1 months |
| Median time before cancer worsened | 10.3 months | 7.5 months |
Why this matters
EGFR exon 20 insertion mutations are an uncommon subtype of EGFR-positive lung cancer. They respond differently from more common EGFR mutations, and many earlier EGFR-targeted medicines have had limited effectiveness for this group.
About Sunvozertinib
Sunvozertinib is an oral targeted therapy designed for people with advanced NSCLC whose tumor has an EGFR exon 20 insertion mutation, a genetic change identified through biomarker testing. Unlike chemotherapy, which affects rapidly dividing cells more broadly, sunvozertinib works by blocking abnormal EGFR signals that can help cancer cells grow. It is taken once daily and is approved in the United States for certain patients whose cancer has progressed after platinum-based chemotherapy. In the WU-KONG28 study, sunvozertinib was also studied as an initial treatment and delayed cancer growth longer than chemotherapy. Possible side effects can include diarrhea, rash or other skin changes, mouth sores, nausea, and changes in liver blood tests; your cancer care team can help monitor and manage side effects and determine whether this treatment is appropriate for you.
Side effects and next steps
The safety results were generally consistent with prior research on sunvozertinib. Treatment-related side effects led 7.4% of patients taking the drug to stop treatment. Researchers reported no treatment-related deaths.
Overall-survival results—whether patients lived longer overall—were not yet mature at the time of the analysis. This is partly because more than 90% of patients whose cancer progressed on chemotherapy switched to sunvozertinib, which can make it harder to compare overall survival between the original treatment groups.
These results may support the use of sunvozertinib as a first-line option for people with advanced NSCLC and an EGFR exon 20 insertion mutation. Patients should ask their oncology team whether comprehensive biomarker testing has identified an EGFR exon 20 insertion and whether a targeted-therapy clinical trial or an approved treatment option is appropriate for their situation.
Reference
Heymach JV, Liu G, Xing L, et al. Sunvozertinib monotherapy versus platinum-based chemotherapy as first-line treatment for advanced NSCLC with EGFR exon20ins: Primary analysis of a multinational phase 3 randomized study (WU-KONG28). J Clin Oncol 44, LBA8500(2026). Volume 44, Number 17_suppl
