The trial plans to enrol 460 relapsed small cell lung cancer patients who have progressed following a single prior line of chemotherapy. Credit: mi_viri / Shutterstock.

Daiichi Sankyo and MSD (Merck and Co.) have announced the dosing of the first subject in the Phase III IDeate-Lung02 clinical trial of ifinatamab deruxtecan (I-DXd) in people with relapsed small cell lung cancer (SCLC).

Discovered by Daiichi Sankyo and co-developed with MSD, I-DXd is a B7-H3-directed DXd antibody-drug conjugate (ADC).

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The global, multi-centre, randomised, open-label trial aims to assess the efficacy and safety of I-DXd against the physician’s choice of chemotherapy comprising amrubicin, lurbinectedin or topotecan.

It will enrol 460 relapsed SCLC patients who have progressed following a single prior line of platinum-based chemotherapy across Asia, Oceania, Europe, North America, and South America.

Patients will be randomised in the trial to receive either 12mg/kg I-DXd or chemotherapy.

Objective response rate (ORR) and overall survival are the trial’s dual primary endpoints.

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Secondary endpoints include ORR, progression-free survival, duration of response, disease control rate, and time to response.

Daiichi Sankyo oncology clinical development global head Mark Rutstein said: “Patients living with small cell lung cancer face poor outcomes with currently available treatments.

“The IDeate-Lung02 trial is an important next step as we look to better understand the role of ifinatamab deruxtecan as a potential new medicine for patients with certain types of small cell lung cancer.”

Daiichi Sankyo and MSD formed an international partnership in October last year for the co-development and co-commercialisation of I-DXd, patritumab deruxtecan (HER3-DXd), and raludotatug deruxtecan (R-DXd).

The deal excludes Japan, where Daiichi Sankyo retains exclusive rights.

Merck Research Laboratories global clinical development oncology head and senior vice-president Marjorie Green said: “The initiation of the IDeate-Lung02 trial for ifinatamab deruxtecan marks the second pivotal study since the start of our collaboration with Daiichi Sankyo and follows the recent initiation of the REJOICE-Ovarian01 Phase II/III study for raludotatug deruxtecan.”

In April this year, the companies dosed the first subject in the Phase II/III REJOICE-Ovarian01 trial of R-DXd in platinum-resistant, ovarian cancer patients.