Merck and Daiichi Sankyo’s ADC ifinatamab deruxtecan shows promise in SCLC

Merck & Co, known as MSD outside the US and Canada, and Daiichi Sankyo have presented promising findings for their investigational antibody-drug conjugate (ADC), ifinatamab deruxtecan, in a mid-stage lung cancer study. Data from the IDeate-Lung01 phase 2 trial, which has been examining the drug in patients with pre-treated extensive-stage small cell lung cancer (SCLC), were shared at the World Conference on Lung Cancer.

The trial results showed that after a median follow-up period of about 15 months, patients receiving ifinatamab deruxtecan demonstrated confirmed objective response rates of 54.8% and 26.1% in the 12mg/kg and 8mg/kg dose groups, respectively. Specifically, in the 12mg/kg cohort, 23 instances of partial response (PR) were observed, whereas the 8mg/kg group saw one complete response and 11 partial responses.

The data also indicated that the median duration of response for the 12mg/kg dose was 4.2 months, compared to 7.9 months for the 8mg/kg dose. However, the disease control rate, median duration of treatment, and median progression-free survival were higher in the 12mg/kg group, which has been chosen for the upcoming dose expansion phase of the trial. The median overall survival was reported at 11.8 months for the 12mg/kg dose and 9.4 months for the 8mg/kg dose.

Lung cancer remains the leading cause of cancer-related deaths worldwide, with SCLC representing about 15% of all lung cancer cases. SCLC is known for its rapid progression, and approximately 70% of patients are diagnosed at an extensive stage where the cancer has spread beyond the lungs to other parts of the body.

Ifinatamab deruxtecan, discovered by Daiichi Sankyo and being co-developed with Merck, is designed to target the B7-H3 protein, which is overexpressed in various cancer types, including SCLC. Marjorie Green, senior vice president and head of oncology global clinical development at Merck Research Laboratories, remarked on the encouraging results, emphasizing the potential of B7-H3 as an actionable target in SCLC. She expressed anticipation for advancing the pivotal clinical development program for ifinatamab deruxtecan.

Additionally, ifinatamab deruxtecan is under evaluation in patients with relapsed SCLC, advanced solid malignant tumors, and recurrent or metastatic solid tumors. Mark Rutstein, global head of oncology clinical development at Daiichi Sankyo, expressed optimism about the forthcoming results from the extension part of the IDeate-Lung01 phase 2 trial and the newly initiated IDeate-Lung02 phase 3 trial, which will compare ifinatamab deruxtecan against the physician's choice of chemotherapy in patients with extensive-stage SCLC.

In summary, the investigational drug ifinatamab deruxtecan has shown promising efficacy and safety profiles in treating extensive-stage small cell lung cancer, especially at a higher dose of 12mg/kg. The ongoing and future trials aim to further evaluate and potentially establish the drug as a viable treatment option for SCLC patients.

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