Daiichi, Merck report positive phase 2 lung cancer ADC data

Daiichi Sankyo and Merck shared promising results from the ongoing IDeate-Lung01 phase 2 trial of ifinatamab deruxtecan in extensive-stage small cell lung cancer (ES-SCLC). The trial indicated a noteworthy objective response rate of 54.8% in the cohort receiving a 12 mg/kg dose, compared to a 26.1% response rate in the cohort receiving an 8 mg/kg dose. Furthermore, the median overall survival rate was reported to be 11.8 months for the higher dose and 9.4 months for the lower dose. Intracranial responses were also observed in patients with brain lesions, leading to the selection of the 12 mg/kg dose for the expansion phase of the trial.

Ifinatamab deruxtecan is classified as a B7-H3-directed antibody-drug conjugate (ADC). It targets the B7-H3 protein, which is commonly overexpressed in cancer cells. The drug binds to the B7-H3 protein and is subsequently internalized into the cancer cell. Once inside, it releases a potent chemotherapy agent that causes targeted DNA damage, ultimately leading to the death of the cancer cell. This mechanism allows for a more precise attack on cancer cells while minimizing damage to healthy tissues.

Last month, Daiichi Sankyo and Merck expanded their antibody-drug conjugate (ADC) partnership to include the co-development and co-commercialization of Merck’s investigational T-cell engager, MK-6070. MK-6070 targets the DLL3 protein and is currently undergoing phase 1/2 trials for small cell lung cancer (SCLC) and neuroendocrine tumors. This new partnership builds on a previous $22 billion deal to develop ADC drug candidates such as patritumab deruxtecan, ifinatamab deruxtecan, and raludotatug deruxtecan.

As part of this expanded collaboration, the companies will explore combining MK-6070 with Daiichi Sankyo’s ifinatamab deruxtecan for specific SCLC patients. Merck will receive $170 million upfront, and both companies will share development costs and profits. However, in Japan, Daiichi Sankyo will receive royalties.

The collaboration between Daiichi Sankyo and Merck represents a significant step in the development of targeted therapies for small cell lung cancer and other aggressive tumors. The promising results from the IDeate-Lung01 phase 2 trial and the expansion of their partnership underscore the potential of ADCs and T-cell engagers in improving outcomes for patients with difficult-to-treat cancers.

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