Cullinan Therapeutics and Partners Showcase Breakthrough Cancer Trial Findings

Cullinan Therapeutics and Partners Showcase Breakthrough Cancer Trial Findings

CAMBRIDGE, Mass. and TOKYO, Japan and PRINCETON, N.J. – Cullinan Therapeutics, Inc. (NASDAQ: CGEM), Taiho Pharmaceutical Co., Ltd., and Taiho Oncology, Inc. have recently reported promising findings from the pivotal Phase 2b cohorts of the REZILIENT1 trial. This important clinical trial focuses on zipalertinib, a novel treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) specifically harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations. These exciting results are slated for presentation on June 1 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting during an oral presentation session dedicated to non-small cell lung cancer.

The Urgent Need for Effective Treatment Options

Dr. Helena A. Yu, Thoracic Medical Oncologist and Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center, emphasized the urgency for targeted therapies that patients with EGFR ex20ins NSCLC require. As many struggle against this aggressive cancer type, the trial's findings bring hope, indicating that zipalertinib may present a viable new oral treatment option for individuals whose cancer has progressed despite prior therapies.

Results from REZILIENT1 Trial

As of the latest data cutoff, 244 patients had been enrolled in the REZILIENT1 trial and received at least one dose of 100 mg zipalertinib. Analysis of the overall efficacy population revealed noteworthy efficacy outcomes. The key findings include:

• Overall Efficacy Population: Among 176 patients assessed, the confirmed overall objective response rate (ORR) stood at 35%, with a median duration of response (mDOR) of 8.8 months.
• Patients Who Received Prior Platinum-Based Chemotherapy: For 125 of these participants, the ORR was 40%, with an mDOR of 8.8 months, showing consistency with earlier trials.
• Patients with Amivantamab and Chemotherapy: In those treated previously with both chemotherapy and amivantamab (30 patients), the ORR was 30% with an impressive mDOR of 14.7 months.
• Patients with Brain Metastases: Among 68 patients with prior brain metastases included in the study, the ORR was 31%, and the mDOR was 8.3 months.

Understanding the Safety Profile

The safety analysis included all 244 patients who received at least one dose of zipalertinib. Results indicated a manageable safety profile, with most treatment-related adverse events (TRAEs) classified as grade 1 or 2. Common TRAEs were reported as:

• Paronychia (38.5%)
• Rash (30.3%)
• Dermatitis acneiform (24.6%)
• Dry skin (24.6%)
• Diarrhea (21.7%)
• Stomatitis (20.1%)

Furthermore, the most significant grade ?3 TRAEs included anemia (7%) and pneumonitis, along with rash (2.5%, each). These safety findings affirm that zipalertinib can be administered effectively to patients who have undergone various treatments.

Insights on Zipalertinib and Its Development

Zipalertinib (development code: CLN-081/TAS6417) represents a significant advancement in targeted therapies, engineered to inhibit EGFR variants, particularly those with exon 20 insertion mutations while preserving the wild-type EGFR function. This selective targeting positions zipalertinib as a pioneering irreversible EGFR inhibitor tailored for patients with non-small cell lung cancer, focusing on optimizing treatment outcomes for this specific genetic alteration. Its development is notably bolstered by the Breakthrough Therapy Designation granted by the FDA, highlighting the treatment's potential.

Collaborative Commitment to Innovation

Cullinan Therapeutics, Taiho Pharmaceutical, and Taiho Oncology are actively collaborating in the development of zipalertinib, combining their unique strengths and expertise to offer innovative solutions for oncology patients. The collaborative effort underscores a shared commitment to improving the lives of cancer patients through advanced research and the intersection of clinical excellence and patient-centric approaches.

Frequently Asked Questions

What is the REZILIENT1 trial?

The REZILIENT1 trial is a Phase 1/2 clinical study evaluating the efficacy and safety of zipalertinib in patients with advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations.

What were the efficacy results of the trial?

The trial showed a confirmed overall objective response rate of 35% with a median duration of response of 8.8 months in the overall efficacy population.

How safe is zipalertinib?

Zipalertinib demonstrated a generally manageable safety profile, with most treatment-related adverse events being mild (grade 1 or 2).

What is the primary focus of zipalertinib?

Zipalertinib specifically targets EGFR variants with exon 20 insertion mutations in non-small cell lung cancer.

Why is the REZILIENT1 trial significant?

The trial offers promising results for a treatment option that could improve the lives of patients with limited alternatives after prior therapies.

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