Cullinan Therapeutics has announced that its pipeline candidate zipalertinib has been beneficial as a combination therapy. Image credit: Sebastian Kaulitzki / Science Photo Library / Getty Images.

Cullinan Therapeutics has announced positive topline data from a Phase I/II trial of its pipeline candidate zipalertinib, after prior treatment with Rybrevant in patients with non-small cell lung cancer (NSCLC).

The Phase I/II REZILIENT1 trial (NCT04036682) is an open-label, multi-centre study in NSCLC patients harbouring EGFR (epidermal growth factor receptor) exon 20 insertion mutations.

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As of the 12 January 2024 data cut-off, 31 patients had been enrolled in the Phase IIb portion and 18 were evaluable.

There was an objective response rate of 39% and a disease control rate of 94%. Duration-free response and progression-free survival endpoints were not yet evaluable.

Zipalertinib demonstrated a manageable safety profile, with no grade 4 or grade 5 treatment-related adverse events​ (AEs) reported as of the data cut-off.

Cullinan Therapeutics’ chief medical officer Jeffrey Jones said: “Given the recent approval of amivantamab as a first line treatment in combination with chemotherapy, we are encouraged by the initial results of the Phase IIb portion of the REZILIENT1 clinical trial, which show that in a post-amivantamab setting, zipalertinib demonstrated promising efficacy, similar to that in patients who progressed after platinum-based chemotherapy alone, and had a manageable safety profile.”

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Zipalertinib is an epidermal growth factor receptor (EGFR) inhibitor. EGFR is overexpressed in tumour cells and involved in cell proliferation.

Johnson & Johnson’s Rybrevant (amivantamab) is indicated for use in combination with carboplatin-pemetrexed chemotherapy for the first-line treatment of locally advanced or metastatic NSCLC harbouring epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The drug was approved by the US Food and Drug Administration (FDA) on 1 March 2024.

Cullinan Oncology and Taiho Pharmaceutical partnered in 2022, with Taiho taking over subsidiary Cullinan Pearl with an upfront cash payment of $275m. Additional payments totalling $130m will be made for US regulatory approvals.

NSCLC landscape

NSCLC is the most prevalent type of lung cancer, accounting for approximately 80-85% of all lung cancer cases. NSCLC is often diagnosed in advanced stages, making it more challenging to treat.

Current treatment options include targeted therapies and immune checkpoint inhibitors. Targeted therapies have been developed for NSCLC patients with tumours containing alterations in the EGFR and ALK genes, however, only a small percentage of patients are eligible for these therapies.

Immune checkpoint inhibitors can be used for NSCLC patients who are ineligible or resistant to targeted therapies. These inhibitors work by activating the patient’s immune system to fight against cancer cells.