Cullinan Therapeutics' Positive Phase 2b Data

Cullinan Therapeutics, Inc. (NASDAQ: CGEM) has released positive initial data from its pivotal phase 2b Rezilient1 study of Zipalertinib, an orally available small molecule designed to target activating mutations in EGFR. The study focused on patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who had previously undergone treatment with Amivantamab.

As of the January 12, 2024, data cut-off, 31 patients had been enrolled in the study, with a median of three prior systemic anti-cancer regimens, including prior platinum-based chemotherapy, prior anti-PD1/L1 therapy, and prior EGFR tyrosine kinase inhibitor (TKI) therapy. Of these, 18 patients were evaluable for response, demonstrating an objective response rate (ORR) of 39% and a disease control rate (DCR) of 94%.

Comparing the results to the phase 1/2a part of the study, the ORR for patients receiving Zipalertinib after prior treatment with Amivantamab was 39%, slightly lower than the 41% ORR for patients post prior chemotherapy. However, the DCR of 94% was similar to the previously reported 97%. Additionally, the drug demonstrated a manageable safety profile, with no grade 4 or grade 5 treatment-related adverse events reported.

Dr. Jeffrey Jones, Chief Medical Officer at Cullinan Therapeutics, expressed confidence in the potential of Zipalertinib to address the unmet need for patients with NSCLC harboring EGFR exon 20 insertion mutations. He highlighted the unique chemical structure of Zipalertinib, which is distinct from other exon 20 insertion directed agents, making it highly selective for mutant exon 20 versus wild-type EGFR.

The company remains on track to complete enrollment in the pivotal phase 1/2b Rezilient1 trial by the end of 2024. Zipalertinib has also received breakthrough therapy designation from the FDA. Cullinan Therapeutics has a comprehensive development plan for Zipalertinib, with ongoing pivotal studies in patients with NSCLC harboring exon 20 insertion mutations, as well as studies in other patient populations such as those with active brain metastases and uncommon EGFR mutations.

Cullinan Therapeutics will host an investor event on June 1, 2024, at 6:30 pm Central Time, during which Dr. Jeffrey Jones will present an overview of the Zipalertinib data. The company has also entered into a partnership with Taiho, with an upfront cash payment of $275 million and additional payments totaling $130 million for US regulatory approvals in 1L and 2L+ NSCLC. Cullinan also retains a 50/50 profit share in the US.

For more information about Cullinan Therapeutics, visit their website at

Following these announcements, the company's shares moved -4.3%, and are now trading at a price of $22.5. Check out the company's full 8-K submission here.

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