Zipalertinib: the briefings and the record

Prognyx briefings on zipalertinib

1. 10 September 2026first-line EGFR exon 20 insertion mutation NSCLCZipalertinib's REZILIENT3 hits its PFS endpoint in first-line EGFR exon 20 lung cancer; full data land 13 September

   Taiho and Cullinan report a Phase 3 first-line PFS win at interim; the hazard ratio and median PFS are not yet disclosed and are set for IASLC on 13 September 2026, while the only regulatory date on record, a 27 February 2027 PDUFA, governs a separate post-platinum filing.

2. 13 August 2026First-line locally advanced or metastatic EGFR-mutant non-small cell lung cancerZipalertinib plus chemo meets its PFS endpoint at interim in first-line EGFR exon 20 NSCLC

   REZILIENT3, a randomised open-label Phase 3 in 285 previously untreated patients, hit its primary endpoint at a planned interim; the Independent Data Monitoring Committee recommended unblinding and the partners will seek US approval pending FDA discussions.

Sourced timeline

Readouts, regulatory actions, filings, trial starts and deals that the Prognyx engine extracted from the documents cited in these briefings, newest first. Each links to its source and to the briefing that cited it. Press coverage is left out, and so is any event dated on its own briefing's day: the briefing above is the record for that day. A month without a day is a date the source gave only to the month.

1. 12 August 2026ReadoutREZILIENT3 meets primary PFS endpoint at interim analysisSEC 8-K Exhibit 99.1 (press release) · cited in Zipalertinib's REZILIENT3 hits its PFS endpoint in first-line E…
2. 20 November 2025FilingRolling NDA submission initiatedPR Newswire (company release) · cited in Zipalertinib's REZILIENT3 hits its PFS endpoint in first-line E…
3. 12 October 2025ReadoutZipalertinib data presented in NSCLC with active brain metastasesPR Newswire (company release) · cited in Zipalertinib's REZILIENT3 hits its PFS endpoint in first-line E…
4. June 2024ReadoutEarlier Phase 1/2a cohort shows 41% ORR and 12-month median PFSSEC 8-K EX-99.1, Cullinan June 1, 2024 release · cited in Zipalertinib plus chemo meets its PFS endpoint at interim in fi…
5. June 2024ReadoutREZILIENT1 shows 39% ORR after prior amivantamabSEC 8-K EX-99.1, Cullinan June 1, 2024 release · cited in Zipalertinib plus chemo meets its PFS endpoint at interim in fi…

Registered trials on file

ClinicalTrials.gov records that the cited sources tie to zipalertinib, each opening on the registry.

• NCT05973773 REZILIENT3
• NCT05967689 Zipalertinib in advanced NSCLC with EGFR exon 20 insertions or other uncommon mutations