A Milestone for Entering the European First-Line Triple-Negative Breast Cancer Market

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the combination therapy of Gilead Sciences' antibody-drug conjugate (ADC), Trodelvy (ingredient: sacituzumab govitecan-hziy), and Merck & Co.'s immune checkpoint inhibitor, Keytruda (ingredient: pembrolizumab). This recommendation applies to adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) with a PD-L1 combined positive score (CPS) of 10 or higher, for first-line therapy. This represents a significant regulatory advancement, as it expands the therapeutic scope of Trodelvy, previously used as a second-line treatment, to the first-line standard of care for the most aggressive form of breast cancer. Upon completion of the final approval by the European Commission (EC), this will open up innovative treatment options for numerous patients in Europe with unmet needs.

Proven Superior Efficacy in the Phase 3 ASCENT-04 Trial

The basis for this positive opinion is the results of the Phase 3 ASCENT-04 (KEYNOTE-D19) trial, which clearly demonstrated the overwhelming clinical benefit of the Trodelvy combination therapy. In this trial, the Trodelvy and Keytruda combination arm reduced the risk of disease progression and death by 35% compared to the chemotherapy and Keytruda combination arm. Specifically, the median progression-free survival (mPFS) in the patients was 11.2 months, compared to 7.8 months in the control arm, which was statistically significant (Hazard Ratio 0.65, p<0.001). This indicates that the combination of cytotoxic chemotherapy and immune checkpoint inhibitors can maximize the synergistic effect, significantly improving the early survival rate of patients with triple-negative breast cancer.

Strengthening Global Breast Cancer Market Position and Diversifying Revenue

Gilead Sciences' Trodelvy recorded global sales of USD $1.4 billion in 2025, driving the growth of Gilead's oncology portfolio. Notably, despite the voluntary withdrawal of the bladder cancer indication in the United States in late 2024, it maintained a 6% increase in sales due to the strong demand in the breast cancer field, which is encouraging. This positive recommendation for approval as a first-line treatment in Europe will be a catalyst to significantly increase Trodelvy's market share in the global triple-negative breast cancer (TNBC) market, which is estimated at approximately USD $5 billion annually. In particular, it will solidify its market leadership against competing drugs such as Dato-DXd, a Trop-2 targeted ADC in the pipeline of Daiichi Sankyo and AstraZeneca.

Challenges in Price Negotiations for Commercial Success

In the European market, in order for the CHMP's positive opinion and the European Commission's final approval to translate directly into a surge in sales, it is necessary to overcome the barriers of price negotiations (Pricing and Reimbursement) in each country. European major countries determine coverage based on economic evaluations, so Gilead must fully demonstrate the improved clinical cost-effectiveness compared to existing standard therapies. In particular, strategic approaches are required, as the timing of actual revenue contribution may vary depending on the speed of price negotiations with national health authorities and the scope of coverage under national health insurance. Nevertheless, given the characteristics of the first-line TNBC market with very high unmet needs, there is a high possibility that a favorable reimbursement environment will be created, which will have a positive impact on Gilead's medium- to long-term performance.

Transitioning to a Standard Treatment in the Next-Generation Cancer Therapy Market

This decision demonstrates a significant precedent that the combination of ADCs and immune checkpoint inhibitors has been firmly established as a new paradigm for the treatment of solid tumors in the oncology field. Researchers in the industry are expected to further accelerate research to verify the therapeutic efficacy of similar combinations in other solid tumor indications. From the patient's perspective, it is expected to contribute greatly to improving the quality of life by avoiding the administration of highly toxic conventional chemotherapy alone and receiving targeted therapy and immunotherapy early. Ultimately, this recommendation for approval will undoubtedly be a major turning point in advancing the flow of the global cancer treatment market from second-line or later treatment to first-line standard treatment.