Gilead Moves Deeper into Oncology with $21 Billion Acquisition of Immunomedics

On September 14, 2020, Gilead Sciences announced it is moving deeper into oncology through the acquisition of Immunomedics and its breast cancer treatment, Trodelvy, for $21 billion. Trodelvy is expected to become a cornerstone of Gilead Sciences' oncology business.

In late July 2020, Kite, a Gilead company, announced that U.S. Food and Drug Administration (FDA) had granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 

Gilead will acquire Immunomedics as the company seeks regulatory approval of Trodelvy (sacituzumab govitecan-hziy), a first-in-class Trop-2 directed antibody-drug conjugate (ADC) that was granted accelerated approval from the U.S. Food and Drug Administration in April for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Immunomedics plans to submit a supplemental Biologics License Application (BLA) to support full approval of Trodelvy in the United States in the fourth quarter of 2020. Immunomedics is also on track to file for regulatory approval in Europe in the first half of 2021. That early approval marked the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies.

“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio. Trodelvy is an approved, transformational medicine for a form of cancer that is particularly challenging to treat. We will now continue to explore its potential to treat many other types of cancer, both as a monotherapy and in combination with other treatments,” Daniel O’Day, chairman and chief executive officer of Gilead Sciences said in a statement.

For Gilead Sciences, the acquisition of the oncology-focused Immunomedics, comes at a time when the company continued to pivot its pipeline away from its vaunted hepatitis treatments and move into oncology. Gilead initially moved into oncology with its acquisition of Kite and that company’s CAR-T program, Yescarta. Earlier this year, Gilead acquired Forty Seven, Inc., a company focused on advancing magrolimab in registration-enabling programs for the treatment of patients with untreated, higher-risk myelodysplastic syndrome (MDS) and heavily-pretreated, relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Trodelvy is now expected to become the cornerstone of Gilead’s oncology business alongside Yescarta and Forty Seven’s magrolimab, which is being assessed as a treatment for several cancers, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and diffuse large B-cell lymphoma (DLBCL).

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