#None #Taiho Oncology #Cullinan Therapeutics #Zipalertinib

Promising Data on Zipalertinib Presented at IASLC 2025 World Conference

On September 9, 2025, Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. showcased novel findings from their clinical trials focusing on zipalertinib, an oral EGFR tyrosine kinase inhibitor. The data presented at the IASLC 2025 World Conference on Lung Cancer delivered insights that could reshape treatment pathways for patients with non-small cell lung cancer (NSCLC) harboring specific EGFR mutations.

Overview of Trials: REZILIENT1 and REZILIENT2

The presentation primarily focused on two critical trials: REZILIENT1 and REZILIENT2. These trials examined the efficacy and safety of zipalertinib in patients diagnosed with advanced or metastatic NSCLC characterized by various EGFR mutations. Zipalertinib has the potential to target not only conventional mutations but also the less common ones that do not respond well to existing therapies.

REZILIENT1 Trial Key Findings

In the REZILIENT1 trial, which included patients who had already undergone treatment with amivantamab, significant data was reported:

• - A total of 84 patients were subjected to zipalertinib treatment.
• - The overall confirmed objective response rate (ORR) among these patients was 27.4%, accompanied by a median duration of response (mDOR) of 8.5 months.
• - Those who had previously only received amivantamab (n=54) experienced a higher ORR of 31.5% with a mDOR of 9.5 months.
• - Additionally, for patients with a history of brain metastases receiving only amivantamab (n=31), the systemic ORR reached 29%.

Safety Profile of Zipalertinib

The safety data disclosed a manageable profile for zipalertinib with no new safety signals reported. Common treatment-emergent adverse events included paronychia (41.7%), anemia (38.1%), and rash (34.5%) among others, which suggests a tolerable impact on patients' health during the ongoing therapy.

REZILIENT2 Trial Insights

The REZILIENT2 trial targeted patients with uncommon non-exon 20 insertion EGFR mutations.

• - As of March 2025, 40 patients were enrolled, with a confirmed ORR of 30%, indicating a promising response to the treatment. The median duration of response was reported to be 7.75 months for the overall population.
• - Notably, in treatment-naïve patients (n=8), the ORR surged to 62.5%, signaling a significant potential benefit for newly diagnosed patients.

As with the REZILIENT1 trial, the safety profile remained acceptable, with the majority of treatment-related adverse events being of grade 1 or 2 severity. Common events included paronychia (47.5%) and dermatitis acneiform (37.5%).

Medical Community Response

The medical community has expressed enthusiasm for these findings. According to Dr. Zofia Piotrowska from Harvard Medical School, the data highlights an essential clinical need for patients with the target mutations, especially given the difficulties these patients face despite advancements in treatment. Dr. Hibiki Udagawa emphasized the importance of the ongoing innovations in targeted therapies, indicating a positive shift towards personalized medicine for those with uncommon mutations.

About Zipalertinib

Zipalertinib (development code CLN-081/TAS6417) is strategically developed to inhibit specific EGFR mutations while sparing the wild-type variant, showcasing its targeted approach. The drug has received a Breakthrough Therapy Designation from the FDA, reflecting its potential to significantly impact patient outcomes.

Taiho Oncology, in collaboration with Cullinan Therapeutics, remains dedicated to advancing the development of zipalertinib, aiming to address persistent gaps in lung cancer treatment.

For more detailed information, you can explore the companies' respective websites. This data represents a pivotal moment in the journey towards more effective treatments for lung cancer patients, exemplifying the ongoing collaboration between research and clinical application.