Daiichi Sankyo and AstraZeneca to test combination therapy for NSCLC. Credit: Ed Uthman.

Daiichi Sankyo and AstraZeneca have partnered to assess patritumab deruxtecan (U3-1402) in combination with Tagrisso (osimertinib) for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC).

Patritumab deruxtecan is a HER3 directed DXd antibody drug conjugate (ADC), while Tagrisso is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).

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The combination will be assessed as a first-line and second-line combination treatment in a multi-centre, open-label, two-part Phase I clinical trial involving patients with an EGFR exon 19 deletion or L858R mutation.

Daiichi Sankyo will sponsor and perform the study, which will evaluate the safety and tolerability of multiple dosing combinations of the drugs. The aim is to establish the recommended combination dose.

The second part of the trial will include a first-line and second-line cohort to further investigate the anti-tumour activity and safety of the combination therapy.

In the first-line cohort, participants will be given the combination. The second-line cohort patients will be treated with only patritumab deruxtecan or the combination.

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A total of up to 258 patients will be enrolled across North America, Europe and Asia.

The primary objectives of the study’s dose escalation part are the safety and tolerability of patritumab deruxtecan and Tagrisso.

Meanwhile, the primary objective of the dose expansion part is the anti-tumour activity as measured by the objective response rate (ORR) and assessed by independent central review.

AstraZeneca Late Stage Development Oncology R&D head Cristian Massacesi said: “In this trial, we will explore a new potential way to treat patients with advanced disease by combining Tagrisso with patritumab deruxtecan, a HER3 directed ADC.

“This combination approach represents one of our strategies of addressing tumour resistance. As we work to continue maximising the benefit Tagrisso can bring to patients, we look forward to collaborating with Daiichi Sankyo in this new area of study.”

Last month, AstraZeneca reported positive data from the Phase III DAPA-CKD trial of Farxiga (dapagliflozin) in adults with chronic kidney disease (CKD).