#United States #Princeton #Taiho Oncology #Cullinan Therapeutics #Zipalertinib

Taiho Oncology & Cullinan Therapeutics at IASLC 2025

Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. have announced that they will present exciting new data related to Zipalertinib at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer (WCLC), scheduled for September 6-9 in beautiful Barcelona, Spain. This year’s conference promises to be a significant event for researchers, oncologists, and industry leaders dedicated to advancing lung cancer treatment and care.

In the spotlight will be updated findings from two pivotal studies—REZILIENT1 and REZILIENT2—focusing on Zipalertinib’s efficacy in treating non-small cell lung cancer (NSCLC) patients exhibiting specific mutations in the epidermal growth factor receptor (EGFR).

What is Zipalertinib?

Zipalertinib, with the development code CLN-081/TAS6417, is designed as an oral small-molecule targeted therapy focused on certain genetic mutations found in lung cancer patients. Particularly, it targets exon 20 insertion mutations while sparing normal (wild-type) EGFR. The drug has been developed with the intent to address significant treatment gaps for patients with NSCLC who possess these mutations.

Upcoming Presentations

The presentations accepted for mini oral sessions include critical updates on:
1. Efficacy and Safety Data from REZILIENT1: This Phase 2b trial focuses on NSCLC patients harboring EGFR exon 20 insertion mutations who have previously been treated with amivantamab. Results from this study highlight Zipalertinib’s potential to significantly improve treatment outcomes for this patient subgroup.

2. Preliminary Findings from REZILIENT2: In addition to the data from REZILIENT1, findings will be shared regarding patients with uncommon non-exon 20 insertion EGFR mutations—a cohort that has been underrepresented in clinical trials but presents a similarly significant unmet need. These results are anticipated to provide further insight into how Zipalertinib could serve as a new treatment option for advanced or metastatic NSCLC.

Dr. Harold Keer, Chief Medical Officer of Taiho Oncology, expressed optimism about the data, stating, "Zipalertinib has previously shown clinical activity against outlier mutations and we are eager to present updated findings that could revolutionize treatment for NSCLC patients."

Moreover, Dr. Jeffrey Jones, CMO of Cullinan Therapeutics, emphasized the ongoing challenge in treating patients with uncommon EGFR mutations, noting the importance of these new data in shaping future therapeutic strategies.

Session Details

Both presentations will occur within the same session, titled _Common and Uncommon EGFR Mutations, New Treatments on the Horizon_. The session is scheduled for Tuesday, September 9, 2025, from 11:30 a.m. to 12:45 p.m. CEST. The abstracts will delve into:

• - Zipalertinib's impact on patients with EGFR exon 20 insertion mutations, previously treated with amivantamab.
• - Phase 2 interim results of the same drug in patients carrying non-ex-20 insertion mutations.

These findings will be essential as healthcare providers continuously seek innovative solutions to treat lung cancer effectively and improve patient outcomes globally.

Conclusion

As the IASLC 2025 approaches, the anticipation surrounding Zipalertinib and these pivotal studies continues to build. The results could mark a turning point in the treatment landscape for NSCLC, particularly for patients with challenging EGFR mutations. Both Taiho Oncology and Cullinan Therapeutics remain committed to developing unique therapies that address unmet medical needs in oncology, potentially leading to better outcomes for patients worldwide. We look forward to sharing these important updates at the conference.