As of the data cutoff date (October 17, 2022), the objective response rate (ORR) was 60.8% with a longest duration of response (DOR) over 11 months.
The pivotal phase 2 study, WU-KONG6, demonstrated that the selective EGFR exon20 insertion inhibitor, sunvozertinib, holds promising antitumor efficacy and a well-tolerated safety profile in treating non-small cell lung cancer (NSCLC) patients with EGFR exon20 insertion mutations, surpassing current available therapies.
Key Points:
- WU-KONG6, the first pivotal phase 2 study, examined sunvozertinib, an EGFR exon20 insertion inhibitor, as a treatment for NSCLC patients with EGFR exon20 insertion mutations.
- The study enrolled 104 Chinese patients, with a median age of 58, who had received a median of 2 prior lines of therapy. Most patients (95.9%) had metastatic disease at enrollment.
- Efficacy analysis involved 97 patients with 30 different confirmed exon20 insertion subtypes.
Additional Points:
- Patients received 300mg of sunvozertinib daily until discontinuation.
- The study’s primary endpoint was the ORR, while a key secondary endpoint was the DOR, both assessed by a blinded independent central review (BICR).
- 32% of patients (n = 31) had baseline brain metastasis. The confirmed ORR was 48.5% among this group.
- Antitumor efficacy was observed regardless of age, gender, smoking status, prior therapies, mutation subtypes, and baseline brain metastasis.
- The safety analysis included all study participants. The majority of treatment-emergent adverse events were grade 1 or 2 and clinically manageable.
Conclusion:
- The study confirms sunvozertinib’s significant antitumor efficacy and safety in NSCLC patients with EGFR exon20 insertion mutations previously treated with platinum-based chemotherapy. A phase 3 study (WU-KONG28) is underway to further assess sunvozertinib in comparison to platinum-based chemotherapy as a first-line treatment.
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Did You Know?
Non-small cell lung cancer accounts for about 85% of all lung cancers.