Announced details
First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR ex20ins mutations who have received no prior treatment
The interim analysis showed a statistically significant and clinically meaningful improvement in progression-free survival in the combination arm
285 patients enrolled in the REZILIENT3 trial (trial enrollment)
Taiho Pharmaceutical is our wholly owned subsidiary. Taiho Oncology is a subsidiary of Taiho Pharmaceutical. In the United States, development is proceeding in partnership with Cullinan Therapeutics.
Cullinan Therapeutics: a biopharmaceutical company based in Massachusetts, USA, that develops medicines for autoimmune diseases and cancer. Its President and Chief Executive Officer is Nadim Ahmed. Taiho Pharmaceutical: a research-driven specialty pharmaceutical company based in Chiyoda-ku, Tokyo, focused on cancer and immune-related diseases. Its Representative Director and President is Kobayashi Masayuki (小林将之). Taiho Oncology: a subsidiary of Taiho Pharmaceutical headquartered in Princeton, New Jersey, USA.
There is no change to the consolidated earnings forecast for the fiscal year ending December 2026. This is considered important progress toward enhancing corporate value over the medium to long term.
The company does not address Contract Value / Offering price.
Burnett H, Emich H, Carroll C, et al. PLOS ONE (2021)
Riess JW, Gandara DR, Frampton GM, et al. Journal of Thoracic Oncology (2018)
| Item | Details |
|---|---|
| Names of Products / Services Covered | Zipalertinib (development codes: CLN-081/TAS6417) plus platinum-based chemotherapy |
| Counterparty | Cullinan Therapeutics, Inc.（Nasdaq: CGEM）, Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc. |
| Counterparty overview | Cullinan Therapeutics: a biopharmaceutical company based in Massachusetts, USA, that develops medicines for autoimmune diseases and cancer. Its President and Chief Executive Officer is Nadim Ahmed. Taiho Pharmaceutical: a research-driven specialty pharmaceutical company based in Chiyoda-ku, Tokyo, focused on cancer and immune-related diseases. Its Representative Director and President is Kobayashi Masayuki (小林将之). Taiho Oncology: a subsidiary of Taiho Pharmaceutical headquartered in Princeton, New Jersey, USA. |
| Relationship with the Company | Taiho Pharmaceutical is our wholly owned subsidiary. Taiho Oncology is a subsidiary of Taiho Pharmaceutical. In the United States, development is proceeding in partnership with Cullinan Therapeutics. |
| Applicable area | First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR ex20ins mutations who have received no prior treatment |
| Quantitative Effects | The interim analysis showed a statistically significant and clinically meaningful improvement in progression-free survival in the combination arm |
| Usage history | 285 patients enrolled in the REZILIENT3 trial (trial enrollment) |
| Impact on Business Performance | There is no change to the consolidated earnings forecast for the fiscal year ending December 2026. This is considered important progress toward enhancing corporate value over the medium to long term. |
| Source | Burnett H, Emich H, Carroll C, et al. PLOS ONE (2021), Riess JW, Gandara DR, Frampton GM, et al. Journal of Thoracic Oncology (2018) |
Items this document does not state (9)
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.Because the prespecified interim analysis showed a statistically significant and clinically meaningful improvement in progression-free survival in the combination arm.