Gilead Secures $210M Financing to Advance Trodelvy in NSCLC Amid ADC Setbacks

Recently, Gilead Sciences announced that it has reached a financing agreement with Abingworth, a life sciences investment group under Carlyle, securing up to $210 million in funding to support the development of its ADC drug Trodelvy (sacituzumab govitecan-hziy) in the field of non-small cell lung cancer.

In exchange for a $210 million investment, if Trodelvy successfully tackles non-small cell lung cancer (NSCLC) and receives regulatory approval for label expansion, Abingworth will receive a fixed payment from Gilead Sciences and will also be entitled to royalties from Trodelvy's NSCLC net sales. However, Gilead will retain full rights to Trodelvy.

Solving the "Urgent Need" of TROP2ADC

Gilead’s Timely Financing for Trodelvy Comes as TROP2-Targeted ADCs Face Setbacks; Funds to Help Bear Financial Risks of Further Drug Development, According to Announcement

Trodelvy is the world's first approved TROP2-targeted ADC. It received accelerated FDA approval in April 2020 for second-line or later treatment of patients with metastatic triple-negative breast cancer (mTNBC), and this indication gained full FDA approval in April 2021.

In addition, Trodelvy is also approved for HR+/HER2- locally advanced or metastatic breast cancer patients who have previously received endocrine therapy and ≥2 lines of systemic therapy (for metastatic cancer), as well as for adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have previously been treated with platinum-containing chemotherapy and PD-1 or PD-L1 inhibitors.

However, on January 22, Gilead Sciences' official website announced that Trodelvy faced a setback in a late-stage clinical trial: In the Phase III Evoke-01 study, Trodelvy failed to meet the primary endpoint of overall survival (OS) in previously treated patients with metastatic non-small cell lung cancer (NSCLC).

However, Gilead mentioned in their announcement that they observed a median overall survival difference of more than three months with Trodelvy in the subgroup of patients who did not respond to prior anti-PD-L1 therapy. Gilead remains confident in its NSCLC program, stating they have seen strong preliminary efficacy from the Phase II combination therapy of Trodelvy and Keytruda (pembrolizumab).

Gilead also revealed that it will explore the potential therapies of Troldelvy to further understand the drug's effects in these patients. According to the press release, Gilead is also investigating the potential applications of Troldelvy in head and neck cancer, gynecological cancers, and gastrointestinal cancers. Currently, a Phase III study for first-line metastatic PD-L1 high NSCLC is recruiting participants.

However, the market's reaction to this news was not optimistic, with Gilead Sciences' stock price falling nearly 10% on the same day.

As part of the deal, Gilead agreed to form a joint steering committee with LaunchTherapeutics, a clinical development company backed by Abingworth and The Carlyle Group, to oversee the development of Trodelvy.

LaunchTx was founded in 2022 and focuses on providing various innovative models for pharmaceutical and biotechnology companies, combining capital acquisition with in-depth expertise in drug development, healthcare, clinical operations, regulation, and commercialization.

Gilead's "Crisis"

Currently, Trodelvy's market share in breast cancer is limited to previously treated HR-positive, HER2-negative patients as well as triple-negative patients. Meanwhile, Enhertu (DS-8201), a HER2-targeted ADC jointly developed by competitors Daiichi Sankyo and AstraZeneca, received Breakthrough Therapy designation in early 2024 for the new HER2-low breast cancer category, adding pressure on Trodelvy.

According to Leerink Partners analysts, the approval in the HER2-low breast cancer category not only expands the treatment population for Enhertu but may also reduce Trodelvy's market share, as more tumors are classified as HER2-low breast cancer, meeting the treatment criteria for Enhertu. According to the FDA, 60% of breast cancer diagnoses in the United States are classified as HER2-negative.

The pressure from Enhertu means that expanding Trodelvy's application in NSCLC is key to capturing market share. Perhaps the only way for Gilead Sciences to overcome its current difficulties is to continue focusing on strong clinical data.

However, the strong offensive of Enhertu is just one of the challenges Gilead has faced recently. Gilead has also encountered setbacks in the development of other oncology pipelines.

On February 7, 2024, Gilead Sciences announced the termination of the Phase III clinical trial of the CD47 antibody Magrolimab for the treatment of acute myeloid leukemia (AML), known as the ENHANCE-3 study. The U.S. FDA has placed all Magrolimab studies for myelodysplastic syndromes (MDS) and AML, including related expanded access programs, on a full clinical hold.

On February 15, 2024, Gilead Sciences announced the suspension of patient enrollment in the Magrilimab CD47 antibody study for solid tumors.

And prior to this, Gilead had already suspended three Phase III studies on Magrilimab.

Summary

Despite the setback in Trodelvy's Phase III trial for NSCLC, it still quickly gained capital support, reflecting the firm confidence of the capital market in its potential. Meanwhile, Trodelvy has proven the unique insight of VC investment giants with its own strength. According to Gilead Sciences' 2023 financial report, Trodelvy's total annual sales reached $1.1 billion, a year-on-year increase of 56%, with revenue from the U.S. market being approximately $800 million. This performance fully demonstrates Trodelvy’s market competitiveness and commercial value.

Editor: Pea Shooter

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