Oncology Learning NetworkSunvozertinib Demonstrates Superior Antitumor Efficacy Over Current Available Therapy for NSCLC with EGFR Exon20 Insertion Mutations

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.