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Pfizer, Carrick Therapeutics, Arvinas Partner to Study Combination Therapy in Breast Cancer

NEW YORK – Carrick Therapeutics has partnered with Pfizer and Arvinas to study the CDK7 inhibitor samuraciclib and the estrogen receptor protein degrader vepdegestrant in patients with estrogen receptor (ER)-positive HER2-negative metastatic breast cancer.

Pfizer infused $35 million into Dublin-based Carrick last year to aid its development of samuraciclib in this setting, while vepdegestrant is an investigational product under development at New Haven, Connecticut-headquartered Arvinas. The companies are working together to launch in the second half of this year a Phase Ib/II clinical trial to evaluate the samuraciclib-vepdegestrant combination in ER-positive, HER2-negative metastatic breast cancer patients who have received prior CDK4/6 inhibitor treatment.

Under the agreement, Arvinas will be the regulatory sponsor of the study, and Pfizer will be the acting sponsor for the study in the US. Outside the US, Pfizer will be regulatory and acting sponsor of the study.

Carrick is studying samuraciclib in combination with other treatments in hormone receptor-positive, HER2-negative breast cancer including in ongoing studies with AstraZeneca's hormone therapy Faslodex (fulvestrant), with Roche's selective ER degrader giredestrant, and with Menarini Group's anti-estrogen elacestrant. The firm is also studying samuraciclib in earlier-stage trials in prostate, triple-negative breast, pancreatic, and small cell lung cancer.

Arvinas has several ongoing trials of vepdegestrant in ER-positive, HER2-negative breast cancer including combination studies with Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) and with Novartis' mTOR inhibitor Afinitor (everolimus). In 2021, Arvinas began a global collaboration with Pfizer to co-develop and co-commercialize vepdegestrant.