Trodelvy Misses Mark in NSCLC Trial, Gilead Shares Slide 10%

In recent years, antibody-drug conjugates (ADCs) have been a central point of interest for pharmaceutical companies, with numerous deals being made in this sector. However, Gilead Sciences encountered a challenge with its ADC, Trodelvy (sacituzumab govitecan-hziy), which did not meet the primary endpoint in a pivotal clinical trial.

The Phase III Evoke-01 study was designed to evaluate the effectiveness of Trodelvy in comparison to the standard chemotherapy drug docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) who had previously received treatment. Unfortunately, the drug did not demonstrate a statistically significant improvement in overall survival, a key measure in cancer trials.

Despite this setback, Gilead plans to delve deeper into the data to better understand the drug's potential role in treating these patients. Although the detailed results of the trial have not been released, the company intends to discuss the findings with regulatory authorities and present the data at an upcoming medical conference.

The financial markets responded swiftly to the news, with Gilead's stock price experiencing a significant drop of nearly 10%. Nevertheless, Gilead's Chief Medical Officer, Merdad Parsey, expressed ongoing confidence in Trodelvy's potential, highlighting the drug's ability to address the urgent need for effective treatments in metastatic NSCLC that has progressed after platinum-based chemotherapy.

Gilead also pointed to a positive finding within a specific patient subgroup that had not responded to prior anti-PD-L1 therapy, where Trodelvy showed a median overall survival advantage of over three months. The company remains optimistic about its lung cancer clinical development program and has noted promising preliminary efficacy results from a Phase II study combining Trodelvy with Keytruda (pembrolizumab).

In February 2023, the FDA granted approval for Trodelvy to treat breast cancer, marking a significant milestone as it demonstrated a 30% reduction in the risk of disease progression or death.

Although Trodelvy has not yet received regulatory approval for metastatic NSCLC, Gilead highlighted that it is the first Trop-2-directed ADC to show meaningful survival benefits in two distinct types of metastatic breast cancers and to improve clinical outcomes for certain individuals with metastatic urothelial cancer.

The ADC market remains a vibrant area of focus in oncology, with significant mergers and acquisitions activity. Gilead has been an active participant in this space, both through internal development and acquisitions, such as its $21 billion acquisition of Immunomedics in 2020, which brought Trodelvy into its portfolio.

The trend continues into early 2024, with major deals such as Roche's potential $1 billion agreement with MediLink Therapeutics to advance oncology-focused ADC development.

Despite the setback in the Evoke-01 study, Gilead's commitment to advancing cancer treatments through innovative approaches like ADCs remains strong, and the company continues to explore new avenues to improve patient outcomes.