Merck & Co – known as MSD outside the US and Canada – and Daiichi Sankyo’s investigational antibody-drug conjugate (ADC) ifinatamab deruxtecan has demonstrated promising results in a mid-stage lung cancer study.
Data from the ongoing IDeate-Lung01 phase 2 trial, which has been evaluating the candidate in patients with pre-treated extensive-stage small cell lung cancer (SCLC), was presented at this year’s World Conference on Lung Cancer.
After a median follow-up of around 15 months, confirmed objective response rates of 54.8% and 26.1% were observed in patients receiving ifinatamab deruxtecan in the 12mg/kg and 8mg/kg dose groups, respectively. In the 12mg/kg cohort, 23 partial responses (PR) were seen, while one complete response and 11 PRs were achieved for 8mg/kg.
The median duration of response was 4.2 months for 12mg/kg versus 7.9 months for 8mg/kg, but disease control rate, median duration of treatment and median progression-free survival was greater in the higher dose group, which has been selected for the dose expansion part of the trial. Median overall survival was 11.8 months for 12mg/kg and 9.4 months for 8mg/kg.
Lung cancer is the leading cause of cancer-related deaths globally and SCLC accounts for about 15% of all cases.
SCLC progresses quickly and approximately 70% of patients are diagnosed with extensive-stage disease, meaning their cancer has spread throughout the lung, to the other lung, or to other parts of the body.
Discovered by Daiichi Sankyo and being jointly developed with Merck, ifinatamab deruxtecan is designed to target the B7-H3 protein that is overexpressed in a wide range of cancer types, including SCLC.
Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said: “We are encouraged by these results supporting the potential of B7-H3 as an actionable target in SCLC and look forward to advancing our pivotal clinical development programme for ifinatamab deruxtecan.”
Ifinatamab deruxtecan is also currently being evaluated in patients with relapsed SCLC, advanced solid malignant tumours, and recurrent or metastatic solid tumours.
Mark Rutstein, global head, oncology clinical development at Daiichi Sankyo, said: “We look forward to seeing additional results from the extension part of the IDeate-Lung01 phase 2 trial and the recently initiated IDeate-Lung02 phase 3 trial where we are evaluating ifinatamab deruxtecan in patients with extensive-stage SCLC versus treatment of physician’s choice of chemotherapy.”