Announced details
First-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations in patients with no prior treatment
Median progression-free survival of 14.5 months versus 8.5 months, a difference of 6.0 months. Hazard ratio: 0.50 (95% confidence interval: 0.34–0.73, P=0.00015). Objective response rate of 65.0% versus 40.3%; median duration of response of 14.2 months versus 9.9 months.
285 patients enrolled in the trial. Following safety confirmation, 279 patients were randomized (140 in the combination group and 139 in the chemotherapy-alone group).
Taiho Pharmaceutical is a wholly owned subsidiary of Otsuka Holdings, and Taiho Oncology is its subsidiary. Taiho Pharmaceutical and Taiho Oncology are partnering with Cullinan Therapeutics in the US to develop zipalertinib.
Cullinan Therapeutics is a biopharmaceutical company based in Massachusetts, US, developing T-cell engagers for autoimmune diseases and cancer. Taiho Pharmaceutical is an operating company of Otsuka Holdings based in Chiyoda-ku, Tokyo. Taiho Oncology is a subsidiary of Taiho Pharmaceutical based in New Jersey, US, focused on the development and commercialization of oral anticancer drugs.
ClinicalTrials.gov number: NCT05973773. Other registration numbers and expiration dates: Not disclosed
Taiho Pharmaceutical: Chiyoda-ku, Tokyo. Taiho Oncology: New Jersey, US. Cullinan Therapeutics: Massachusetts, US. WCLC venue: Seoul, South Korea.
There is no change to the consolidated earnings forecast for the fiscal year ending December 2026. Zipalertinib is positioned as one of the product groups expected to drive future growth, and this is viewed as important progress toward enhancing corporate value over the medium to long term.
The company does not address Contract Value / Offering price.
IASLC 2026 World Conference on Lung Cancer (WCLC), ClinicalTrials.gov, the PLOS ONE paper by Burnett et al., and the Journal of Thoracic Oncology paper by Riess et al.
| Item | Details |
|---|---|
| Names of Products / Services Covered | Zipalertinib (CLN-081/TAS6417), REZILIENT3 trial |
| Counterparty | Cullinan Therapeutics, Inc.（Nasdaq: CGEM）, Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc. |
| Counterparty overview | Cullinan Therapeutics is a biopharmaceutical company based in Massachusetts, US, developing T-cell engagers for autoimmune diseases and cancer. Taiho Pharmaceutical is an operating company of Otsuka Holdings based in Chiyoda-ku, Tokyo. Taiho Oncology is a subsidiary of Taiho Pharmaceutical based in New Jersey, US, focused on the development and commercialization of oral anticancer drugs. |
| Relationship with the Company | Taiho Pharmaceutical is a wholly owned subsidiary of Otsuka Holdings, and Taiho Oncology is its subsidiary. Taiho Pharmaceutical and Taiho Oncology are partnering with Cullinan Therapeutics in the US to develop zipalertinib. |
| Applicable area | First-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations in patients with no prior treatment |
| Registration number and expiry date | ClinicalTrials.gov number: NCT05973773. Other registration numbers and expiration dates: Not disclosed |
| Location | Taiho Pharmaceutical: Chiyoda-ku, Tokyo. Taiho Oncology: New Jersey, US. Cullinan Therapeutics: Massachusetts, US. WCLC venue: Seoul, South Korea. |
| Quantitative Effects | Median progression-free survival of 14.5 months versus 8.5 months, a difference of 6.0 months. Hazard ratio: 0.50 (95% confidence interval: 0.34–0.73, P=0.00015). Objective response rate of 65.0% versus 40.3%; median duration of response of 14.2 months versus 9.9 months. |
| Usage history | 285 patients enrolled in the trial. Following safety confirmation, 279 patients were randomized (140 in the combination group and 139 in the chemotherapy-alone group). |
| Impact on Business Performance | There is no change to the consolidated earnings forecast for the fiscal year ending December 2026. Zipalertinib is positioned as one of the product groups expected to drive future growth, and this is viewed as important progress toward enhancing corporate value over the medium to long term. |
| Source | IASLC 2026 World Conference on Lung Cancer (WCLC), ClinicalTrials.gov, the PLOS ONE paper by Burnett et al., and the Journal of Thoracic Oncology paper by Riess et al. |
Items this document does not state (7)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.In the planned interim analysis of the REZILIENT3 trial, the group receiving zipalertinib in combination with platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful extension in progression-free survival compared with the chemotherapy-alone group.