Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal

Now accepting nominations for the Fierce Innovation Awards - Submit your application today Biotech Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal By Nick Paul Taylor Aug 13, 2026 6:00am Taiho Pharmaceutical Cullinan Therapeutics non-small cell lung cancer Clinical Data Taiho Pharmaceutical and Cullinan Therapeutics have scored a second phase 3 victory for their small molecule EGFR inhibitor, teeing the partners up to challenge Johnson & Johnson for a lung cancer niche. The study evaluated the combination of zipalertinib and platinum-based chemotherapy in the first-line treatment of adults with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. Investigators randomized 285 patients to receive the combination or chemotherapy alone.

Progression-free survival (PFS) was significantly longer on the combination than on chemotherapy alone, hitting the study’s primary efficacy endpoint at a planned interim analysis. The partners have yet to share the PFS data but called the improvement “clinically meaningful.” Based on the data, which the partners said showed a “manageable” safety profile, the independent data monitoring committee recommended unblinding the study. Investigators will continue to monitor safety and efficacy.

Taiho and Cullinan plan to seek approval for the zipalertinib-chemotherapy combination in the first-line setting. In April, the FDA accepted zipalertinib for review in NSCLC patients with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. The FDA is set to approve or reject zipalertinib in that setting by Feb.

27 next year. Under the terms of its 2022 deal with Taiho, Cullinan is in line to receive $30 million when zipalertinib is approved for second-line use and $100 million when it secures a first-line nod from the FDA. Taiho and Cullinan will split pretax profits from U.S.

sales equally. Responsibility for driving those sales will fall on Taiho, which already markets three cancer drugs—Inqovi, Lonsurf and Lytgobi—that won FDA approval this decade. Zipalertinib will enter an NSCLC niche already served by Johnson & Johnson’s Rybrevant, a bispecific that received FDA approval for second-line use in 2021 and a first-line nod in 2024.

Sales of Rybrevant and Lazcluze, a drug used in combination with the bispecific in some settings, grew (PDF) 70% to $546 million in the first half of 2026. J&J has grown sales amid a lack of competition for the EGFR exon 20 NSCLC market. Takeda withdrew its challenger, Exkivity, in 2023 over a failed trial, leaving J&J without a rival until the FDA approved Dizal Pharmaceutical’s Zegfrovy in 2025.

Competition for the market is intensifying. AstraZeneca, which created Dizal in a spinout in 2017, paid $600 million upfront for exclusive global rights to Zegfrovy last month. If zipalertinib wins FDA approval, Taiho will be locked in a three-way fight with AstraZeneca and J&J for the NSCLC niche.

Taiho Pharmaceutical Cullinan Therapeutics non-small cell lung cancer Clinical Data EGFR-mutated lung cancer Johnson & Johnson AstraZeneca Dizal Pharma Biotech Clinical Data