Merck and Daiichi Sankyo's Lung Cancer Treatment Receives FDA Breakthrough Designation

Merck-Daiichi Sankyo's potential lung cancer treatment has received FDA Breakthrough Designation. Merck & Co. is a pharmaceutical company that develops and markets therapeutic products and vaccines, including treatments for hypertension, osteoporosis, and respiratory diseases. Their products are sold in various regions, including the US, Europe, China, Japan, and Latin America.

Merck & Co., Inc., and Daiichi Sankyo have announced that ifinatamab deruxtecan, a B7-H3 directed antibody drug conjugate (ADC), has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer (SCLC) who have disease progression on or after platinum-based chemotherapy [1]. This designation is designed to accelerate the development and regulatory review of potential new medicines that address a significant unmet medical need.

The BTD was granted based on data from the IDeate-Lung01 Phase 2 trial, with support from the IDeate-PanTumor01 Phase 1/2 trial. The primary endpoint of the IDeate-Lung01 trial was objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Results from the primary analysis of the trial will be presented in a late-breaking oral presentation at the IASLC 2025 World Conference on Lung Cancer [2].

This is the first BTD for ifinatamab deruxtecan and represents the fourteenth BTD granted by the FDA across the oncology portfolio of Daiichi Sankyo. The companies are committed to advancing this medicine to bring the first B7-H3 directed ADC to patients and transform the outcomes of those facing this aggressive disease [3].

Ifinatamab deruxtecan is an investigational potential first-in-class B7-H3 directed ADC, designed using Daiichi Sankyo’s proprietary DXd ADC Technology. It is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The drug has been granted orphan drug designation by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare, and Taiwan Food and Drug Administration for the treatment of SCLC [4].

The global clinical development program is evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other anticancer medicines across multiple cancers. The companies have a global collaboration to jointly develop and commercialize several ADCs, including ifinatamab deruxtecan [5].

References:
[1] https://www.merck.com/news/ifinatamab-deruxtecan-granted-breakthrough-therapy-designation-by-u-s-fda-for-patients-with-pretreated-extensive-stage-small-cell-lung-cancer/
[2] https://www.iaslc.org/
[3] https://www.daiichisankyo.com/
[4] https://www.fda.gov/
[5] https://www.merck.com/