Dizal Takes Adjuvant ZEGFROVY Data in Resected EGFR Exon 20 Insertion NSCLC to WCLC 2026

From second line to the operating room

Professor Chang Chen's poster moves sunvozertinib furthest from its label. The drug is approved in China and the United States for locally advanced or metastatic NSCLC with EGFR exon 20 insertions after platinum-based chemotherapy; the adjuvant abstract studies it in patients whose stage IB-IIIB tumors have been resected. Dizal characterizes the efficacy as promising, reports no new safety signals, and says the data have already prompted a randomized pivotal trial in the adjuvant setting. None of the underlying numbers appear in the announcement, so the Sept. 13 poster session is where the case will be made.

The second abstract, from Professor Yongchang Zhang, updates a Phase 2 of sunvozertinib plus anlotinib as first-line treatment for NSCLC with EGFR sensitizing mutations and co-mutations, a regimen Dizal describes as oral and chemotherapy-free.

Where the label stands

China granted accelerated approval in August 2023 on WU-KONG6. The FDA followed on July 2, 2025, on WU-KONG1 Part B, for adults with locally advanced or metastatic EGFR exon20ins NSCLC "as detected by an FDA-approved test" whose disease progressed on or after platinum chemotherapy, with continued approval contingent on confirmatory data. The same day the agency approved Thermo Fisher Scientific's Oncomine Dx Express Test, a next-generation sequencing assay run on the Ion Torrent Genexus Dx System, as the companion diagnostic. The first-line supplemental application, supported by the multinational randomized Phase 3 WU-KONG28 against platinum doublet chemotherapy, is under review at the CDE and the FDA, and on July 14 Dizal announced an exclusive license giving AstraZeneca global rights to ZEGFROVY, with closing expected in the second half of 2026.

WU-KONG28 enrolled treatment-naive patients across 16 countries and regions, according to Dizal's 2025 release, which also recalled single-agent first-line data shown at ESMO 2023: a confirmed ORR of 78.6% and median progression-free survival of 12.4 months. "Its convenient once-daily oral dosing substantially improves administration convenience and patient adherence, which is an increasingly critical factor as lung cancer care shifts toward chronic disease management," said Pasi A. Jänne, MD, PhD, of Dana-Farber Cancer Institute, lead principal investigator of WU-KONG1B, in that release.

Why This Matters to the APO|APE Reader

An adjuvant indication for an exon 20 insertion inhibitor would push that specific test back to the resection specimen at stage IB, where the practical driver for reflex EGFR testing today is osimertinib eligibility for classical mutations. The only FDA-approved companion test for this drug is an NGS assay, so the laboratory question attached to the Sept. 13 poster is which platform surgical pathology services will run on early-stage tissue if the randomized adjuvant trial eventually reads out in the drug's favor.