Gilead's Trodelvy-Keytruda Combo Shows Promise in First-Line TNBC Treatment

Gilead Sciences has announced a significant breakthrough in the treatment of triple-negative breast cancer (TNBC), as its antibody-drug conjugate Trodelvy, in combination with Merck & Co.'s Keytruda, has demonstrated superior efficacy compared to the current standard of care in a phase 3 trial.

Groundbreaking Results in TNBC Treatment

The phase 3 Ascent-04 (Keynote-D19) trial has shown that the combination of Trodelvy (sacituzumab govitecan) and Keytruda (pembrolizumab) outperformed Keytruda plus chemotherapy in prolonging progression-free survival in patients with previously untreated metastatic TNBC whose tumors express PD-L1. This marks the first phase 3 trial to demonstrate the superiority of a TROP2-targeted antibody-drug conjugate and an immunotherapy agent in this setting.

Dr. Dietmar Berger, Gilead's chief medical officer, emphasized the significance of these findings, stating, "These findings are the first to show the transformative potential of an antibody-drug conjugate combined with an immuno-oncology agent in early treatment lines of metastatic breast cancer."

Implications for Patient Care and Market Dynamics

The positive results from Ascent-04 come at a crucial time for Gilead, as Trodelvy faces competition from newly approved TROP2 ADCs, including AstraZeneca and Daiichi Sankyo's Datroway in the U.S. and Kelun-Biotech's sacituzumab tirumotecan in China. The success in first-line TNBC treatment could potentially strengthen Trodelvy's market position and provide a much-needed new treatment option for patients.

Gilead estimates that the addressable patient population for this treatment could reach approximately 10,000 across the U.S. and EU5 countries by 2030. Citi analysts project that Trodelvy could achieve peak sales of $3.2 billion by 2030, surpassing the consensus estimate of $2.9 billion.

Future Outlook and Ongoing Studies

While the Ascent-04 trial has shown promising results in progression-free survival, data on overall survival is not yet mature. However, Gilead reports early signs of improvement with the Trodelvy-Keytruda combination.

The company is pursuing additional studies to further establish Trodelvy's efficacy in TNBC treatment. These include the phase 3 Ascent-03 trial, which is evaluating Trodelvy against chemotherapy in first-line, PD-L1-negative metastatic TNBC, with results expected by June. Additionally, the Ascent-05 study is investigating Trodelvy and chemotherapy as an adjuvant treatment for TNBC patients with residual invasive disease after surgery and neoadjuvant therapy.