Gilead to Present New Trodelvy Data at IASLC 2024

Gilead Sciences, Inc., based in Foster City, California, is gearing up to present significant new data from its extensive lung cancer clinical development program. This data will be showcased at the IASLC 2024 World Conference on Lung Cancer, organized by the International Association for the Study of Lung Cancer, from September 7-10, 2024, in San Diego, California. The presentations will feature key findings from three major studies involving the investigational drug Trodelvy® (sacituzumab govitecan-hziy).

Trodelvy, an antibody-drug conjugate targeting Trop-2, will be the focus of three oral presentations. The first presentation will offer initial results from two cohorts of the Phase 2 EVOKE-02 study in patients with previously untreated advanced or metastatic non-small cell lung cancer (mNSCLC). The data from Cohorts C (non-squamous) and D (squamous) show promising efficacy when Trodelvy is combined with pembrolizumab and carboplatin. These findings are particularly noteworthy across different PD-L1 statuses in non-AGA-driven mNSCLC, indicating that Trodelvy may be beneficial in the first-line treatment setting.

In his remarks, Merdad Parsey, MD, PhD, Chief Medical Officer of Gilead Sciences, emphasized the expanding evidence of Trodelvy's potential in treating lung cancer. According to Parsey, the EVOKE-02 data suggest that Trodelvy, in combination with pembrolizumab, could significantly impact patients with mNSCLC without the need for additional chemotherapy. These insights also support the ongoing Phase 3 EVOKE-03 study, highlighting Gilead's commitment to enhancing lung cancer care.

The second presentation will focus on a subgroup analysis from the EVOKE-01 study, which examines Trodelvy's efficacy in second-line mNSCLC patients whose tumors did not respond to prior anti-PD-(L)1 therapies. This pre-specified analysis reveals a numerical improvement in overall survival (OS) compared to docetaxel, regardless of patient stability or previous treatment outcomes. Although this analysis was not formally subjected to statistical testing, it provides valuable information on Trodelvy's potential in this patient population.

Further, Gilead will present updated data from the global Phase 2 TROPiCS-03 study, which investigates Trodelvy in patients with extensive-stage small cell lung cancer (ES-SCLC). The new data, which includes additional patients and longer follow-up periods, reinforces the earlier promising activity of Trodelvy in both platinum-resistant and platinum-sensitive ES-SCLC. This supports further exploration of Trodelvy in treating ES-SCLC, addressing a significant unmet medical need.

The schedule for the presentations is as follows:
- September 8, 2:00 PM – 3:15 PM PT: Sacituzumab Govitecan as Second-Line Treatment in Patients with Extensive Stage Small Cell Lung Cancer.
- September 9, 10:45 AM – 12:00 PM PT: Sacituzumab Govitecan + Pembrolizumab + Carboplatin in 1L Metastatic Non-Small Cell Lung Cancer: The EVOKE-02 Study.
- September 9, 10:45 AM – 12:00 PM PT: Sacituzumab Govitecan vs. Docetaxel in Patients With mNSCLC non-Responsive to Last anti-PD-(L)1–Containing Regimen: EVOKE-01.

It is important to note that Trodelvy has not yet received regulatory approval for treating mNSCLC or ES-SCLC, and its safety and efficacy for these indications remain unestablished. The drug does carry a boxed warning for severe or life-threatening neutropenia and severe diarrhea, which necessitates careful monitoring and management.

Trodelvy has shown significant potential across various cancer types and is currently approved in nearly 50 countries for specific indications, such as metastatic triple-negative breast cancer (TNBC) and hormone receptor-positive, HER2-negative breast cancer. Gilead continues to explore Trodelvy's utility in other cancer types, including lung cancer, highlighting its ongoing commitment to advancing cancer treatment.

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