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January 11, 2022

Gilead and Merck to trial Trodelvy-Keytruda combo for lung cancer

The Phase III trial of Trodelvy plus Keytruda to treat metastatic NSCLC will be sponsored by Merck.

Gilead Sciences and Merck (MSD) have signed two clinical trial partnership and supply agreements to assess Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) for first-line metastatic non-small cell lung cancer (NSCLC). 

Gilead’s antibody-drug conjugate, Trodelvy precisely acts on the Trop-2 expressing cells to facilitate local delivery of a cytotoxic payload that specifically destroys the targeted cells. 

Combining Trodelvy with an immune-stimulating agent such as Keytruda from Merck is claimed to potentially offer a new therapeutic option for a wider group of first-line metastatic NSCLC patients.

Under the partnership, Merck will sponsor an international Phase III trial of Trodelvy plus Keytruda as a first-line therapy for these patients. 

Everest Medicines will also take part in this trial in Asia through a current partnership agreement signed with Gilead.

Under a recently signed contract, Gilead will serve as the sponsor for a Phase II signal-seeking trial of Trodelvy plus Keytruda, along with pembrolizumab, for first-line NSCLC treatment.

The agreements come after a partnership entered in October last year to assess Trodelvy plus Keytruda as first-line therapy for locally advanced or metastatic triple-negative breast cancer (TNBC).

Gilead Sciences chief medical officer Merdad Parsey said: “We’re excited to broaden our clinical collaborations with Merck to investigate Trodelvy in combination with Keytruda in another cancer where there is a tremendous need for novel combinations to help improve patient outcomes. 

“This partnership builds on our ambition of providing alternatives to traditional chemotherapy with Trodelvy containing regimens across some of the most difficult-to-treat cancers.”

Last November, Gilead and Everest reported that sacituzumab govitecan met the primary endpoint in a Phase IIb EVER-132-001 trial in individuals with metastatic TNBC.

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