Gilead encountered a significant setback concerning its antibody-drug conjugate (ADC) Trodelvy. The phase 3 EVOKE-1 trial brought to light that Trodelvy did not exhibit a substantial extension in the lives of patients previously treated for metastatic non-small cell lung cancer (NSCLC) when compared to the chemotherapy docetaxel. Consequently, the trial fell short of meeting its primary endpoint, a revelation made by Gilead.
Despite this setback, Gilead’s Chief Medical Officer, Merdad Parsey, conveyed unwavering confidence in Trodelvy’s potential, drawing on the “totality of our data.” Parsey underscored the intricate challenges in addressing metastatic NSCLC following platinum-based chemotherapy and stressed the pressing need for treatments that are both safe and efficacious.
Gilead intends to unveil the comprehensive trial data at an imminent medical meeting and engage in discussions with regulatory authorities. As part of its overarching strategy in oncology, Gilead has directed its attention to Trodelvy, alongside the cell therapies Yescarta and Tecartus. The company has set an ambitious objective of attaining one-third of its revenue from oncology products by the year 2030.
Trodelvy, recognized as the first FDA-approved TROP2-directed ADC effective against two metastatic breast cancer types, now faces heightened competition within the breast cancer market. The HER2-directed ADC Enhertu, a collaborative effort between Daiichi Sankyo and AstraZeneca, has received approval in the novel HER2-low breast cancer category, presenting a formidable challenge to Trodelvy’s market standing.
The HER2-low designation, applicable to 60% of U.S. breast cancer diagnoses previously categorized as HER2-negative, broadens Enhertu’s treatment scope and poses a potential threat to Trodelvy’s market share.
Gilead is actively exploring Trodelvy’s prospects in head and neck, gynecological, and gastrointestinal cancers, with an ongoing phase 3 study focusing on first-line metastatic PD-L1 high NSCLC. The setback in the NSCLC trial resulted in a 10% decline in Gilead’s shares after having reached an 11-month high.
Despite the industry’s fervor for ADCs, concerns related to safety have surfaced, particularly in connection with interstitial lung disease (ILD). Daiichi Sankyo and AstraZeneca reported seven ILD-related deaths in their TROP2 ADC Dato-DXd study. However, the overall risk-benefit assessment favored the drug. Notably, Gilead’s EVOKE-1 study of 601 patients did not uncover any new safety signals.
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