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

Merck & Co Inc and Daiichi Sankyo's investigational drug, ifinatamab deruxtecan, has received Breakthrough Therapy Designation from the FDA for the treatment of adult patients with extensive-stage small cell lung cancer. This designation aims to expedite development and review, based on promising data from the IDeate-Lung01 phase 2 trial. The drug is a potential first-in-class B7-H3 directed antibody drug conjugate, highlighting its innovative approach. However, its safety and efficacy have not been fully established, and there are inherent risks and uncertainties in drug development. The designation could potentially enhance Merck's oncology portfolio and position the company as a leader in the ADC market.

Merck & Co., Inc. (NYSE: MRK) and Daiichi Sankyo (TSE: 4568) have received a significant milestone in their joint development efforts with the U.S. Food and Drug Administration (FDA) granting Breakthrough Therapy Designation (BTD) to their investigational drug, ifinatamab deruxtecan (I-DXd), for the treatment of adult patients with extensive-stage small cell lung cancer (SCLC) [1].

The BTD designation is based on promising data from the IDeate-Lung01 phase 2 trial, which demonstrated substantial improvement over currently available treatments. This designation aims to expedite the development and regulatory review process, allowing for faster access to potentially life-saving therapies for patients with a serious condition and significant unmet medical needs [1].

I-DXd is a potential first-in-class B7-H3 directed antibody drug conjugate (ADC) that leverages Daiichi Sankyo's proprietary DXd ADC Technology. The drug is designed to target the B7-H3 protein, which is overexpressed in various cancers, including SCLC, and has been shown to correlate with poor prognosis. The Breakthrough Therapy Designation represents the first for ifinatamab deruxtecan and the fourteenth BTD granted across the oncology portfolio of Daiichi Sankyo [1].

The IDeate-Lung01 trial enrolled 187 patients in Asia, Europe, and North America, evaluating the safety and efficacy of ifinatamab deruxtecan in patients with extensive-stage SCLC who had previously received at least one line of platinum-based chemotherapy. The primary endpoint of the trial was the objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1 [1].

While the Breakthrough Therapy Designation signifies a significant step forward, it is essential to recognize the inherent risks and uncertainties associated with drug development. The safety and efficacy of ifinatamab deruxtecan have not yet been fully established, and further clinical trials are necessary to confirm its benefits and potential side effects [1].

The designation could potentially enhance Merck's oncology portfolio and position the company as a leader in the ADC market. However, the success of the drug will depend on the results of ongoing and future clinical trials, as well as regulatory approvals and market acceptance.

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/