- Cullinan Therapeutics (CGEM) and Taiho Oncology announced new preliminary efficacy and safety data for **zipalertinib** from the REZILIENT2 Phase 2b clinical trial in patients with non-small cell lung cancer (NSCLC) harboring EGFR mutations and central nervous system (CNS) involvement.  **[1789972_20251012NE95381:0]** **[1789972_20251012NE95381:1]** 
- As of the **February 2025 data cutoff**, zipalertinib demonstrated an intracranial objective response rate of **31.3%** and an intracranial disease control rate of **68.8%** in evaluable patients with measurable CNS disease.  **[1789972_20251012NE95381:0]** 
- The drug was found to be **well tolerated**, with no new safety signals observed, and treatment-related adverse events of grade 3 or higher occurred in **25%** of patients.  **[1789972_20251012NE95381:0]** 
- These results will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 on **October 19**.  **[1789972_20251012NE95381:0]**

Cullinan Therapeutics and Taiho Oncology Present Zipalertinib Data for NSCLC with Brain Metastases

- Cullinan Therapeutics has updated its guidance for initial clinical data for its lead autoimmune program, **CLN-978** (CD19 x CD3 bispecific), in Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA) to the **first half of 2026**.  **[1789972_2145492_0]**  The company also updated the SLE study protocol to broaden patient eligibility and has **dosed patients in both SLE and RA studies**.  **[1789972_2145492_3]** 
- The company plans a **filing by the end of this year** for its oncology drug **zipalertinib TKI** for EGFR exon 20 non-small cell lung cancer, pending regulatory feedback.  **[1789972_2145492_0]** 
- Cullinan added **belanatamab**, a BCMA-targeting bispecific T cell engager, to its portfolio, with a partner in China, Genrex Bio, planning to initiate a study in autoimmune disease **before year-end 2025**.  **[1789972_2145492_0]** **[1789972_2145492_5]** 
- Cullinan reported **over $500 million in cash reserves at the end of Q2**, providing a **cash runway into 2028**.  **[1789972_2145492_5]**

Cullinan Therapeutics Updates Clinical Timelines and Financial Runway

- CG Oncology has **completed enrollment** in its Phase 3, randomized, open-label PIVOT-006 study.  **[1789972_e52eaaa6c2c24e60a0b4895ac74417f5_0]** 
- The PIVOT-006 study evaluates **cretostimogene grenadenorepvec** against surveillance for patients with **intermediate-risk non-muscle invasive bladder cancer (IR NMIBC)**.  **[1789972_e52eaaa6c2c24e60a0b4895ac74417f5_0]** 
- Enrollment was completed **nearly a year ahead of schedule**, highlighting the significant unmet need for new treatment options in this patient population, where no U.S. FDA-approved options currently exist.  **[1789972_e52eaaa6c2c24e60a0b4895ac74417f5_0]** 
- Cretostimogene is an **investigational oncolytic immunotherapy** being developed as a potential bladder-sparing therapeutic for bladder cancer.  **[1789972_e52eaaa6c2c24e60a0b4895ac74417f5_1]**