FDA Lifts Partial Hold on Merck and Daiichi Sankyo’s B7-H3 ADC Trial for Lung Cancer[6]
The FDA has lifted the partial clinical hold on the IDeate-Lung02 phase 3 trial of ifinatamab deruxtecan (I-DXd), a B7-H3-directed antibody-drug conjugate developed by Merck and Daiichi Sankyo.6
The hold was initially placed in October following a voluntary pause by Daiichi due to a higher-than-anticipated incidence of grade 5 interstitial lung disease (ILD) events, which are fatal and a known side effect of Daiichi's DXd ADCs.124
The trial, involving over 500 patients with relapsed small cell lung cancer, compared I-DXd to standard chemotherapy; enrolled patients continued treatment during the hold, but new recruitment was paused.127
The hold does not impact other I-DXd studies in prostate cancer and esophageal cancer.245
The trial remains on a temporary enrollment pause in the EU pending further regulatory discussions.6
I-DXd received FDA breakthrough therapy designation based on promising phase 2 results showing a 48.2% objective response rate in pretreated extensive-stage small cell lung cancer.23
Sources:
1. https://www.biopharmadive.com/news/merck-daiichi-sankyo-clinical-hold-ifinatamab-deruxtecan/808385/
2. https://www.fiercebiotech.com/biotech/patient-deaths-prompt-partial-hold-daiichi-mercks-global-phase-3-adc-program
3. https://daiichisankyo.us/press-releases/-/article/ifinatamab-deruxtecan-granted-breakthrough-therapy-designation-by-us-fda-for-patients-with-pretreated-extensive-stage-small-cell-lung-cancer
4. https://www.biospace.com/drug-development/patient-deaths-put-merck-daiichi-sankyos-antibody-drug-conjugate-on-hold
5. https://www.oncologypipeline.com/apexonco/lung-toxicity-deaths-halt-ifinatamab
6. https://firstwordpharma.com/story/7058226
7. https://trial.medpath.com/news/df8725ee5d00730a/fda-places-clinical-hold-on-merck-daiichi-sankyo-adc-after-fatal-lung-toxicity-events