An experimental drug from Taiho Oncology and Cullinan Therapeutics worked so well in a hard-to-treat lung cancer that its late-stage trial was stopped early — a strong result in an increasingly crowded field.
The drug, zipalertinib, targets non-small cell lung cancer driven by EGFR exon 20 insertion mutations, an uncommon and stubborn subtype. In a Phase 3 trial testing zipalertinib plus chemotherapy versus chemotherapy alone as a first-line treatment, an interim analysis found a “statistically significant and clinically meaningful improvement” in progression-free survival (how long patients live without the cancer worsening) — enough to halt the study early. Earlier Phase 2 data had shown tumor shrinkage in more than a third of patients on the drug alone.
A competitive race
Zipalertinib is entering a busy market. Johnson & Johnson’s Rybrevant (over $700 million in 2025 sales) and AstraZeneca and Dizal’s Zegfrovy are already approved for this mutation, and ArriVent’s firmonertinib has Phase 3 data expected later in 2026.
What’s next
An FDA decision on zipalertinib is expected by February 27 for a second-line use, with these new first-line data strengthening the case for a broader role. For patients with EGFR exon 20 lung cancer — who long had few good options — more effective, competing therapies is welcome news.