Gilead Trodelvy+Keytruda CHMP: 35% TNBC Risk Cut, ASCENT-04

Gilead Sciences (GILD) announced today that the European Medicines Agency’s CHMP adopted a positive opinion recommending approval of Trodelvy plus Keytruda for first-line treatment of PD-L1 positive metastatic triple-negative breast cancer. The combination reduced the risk of disease progression or death by 35% versus Keytruda alone in the Phase 3 ASCENT-04 trial.

The numbers

• Ticker: GILD
• Stock price: $130.86 (close July 23, 2026)
• Market cap: $162.5 billion
• Drug: Trodelvy (sacituzumab govitecan), a TROP2-directed antibody-drug conjugate (ADC)
• Combination: Trodelvy plus Keytruda (pembrolizumab, Merck’s PD-1 inhibitor)
• Indication: First-line PD-L1 positive metastatic triple-negative breast cancer (TNBC)
• Risk reduction: 35% reduction in disease progression or death vs. Keytruda alone (ASCENT-04)

The CHMP also recommended Trodelvy as a monotherapy for first-line TNBC patients who are not candidates for PD-1/PD-L1 inhibitors, based on the ASCENT-03 trial showing a 38% risk reduction versus chemotherapy. Together, these two opinions would cover the full first-line TNBC population across PD-L1 status.

What this means

Trodelvy is an antibody-drug conjugate: it links a tumor-targeting antibody to a chemotherapy payload, delivering the chemo directly to cancer cells expressing TROP2, a protein found on most breast cancers. The ADC plus checkpoint inhibitor combination attacks the tumor from two angles: the ADC delivers targeted cell killing while the checkpoint inhibitor releases the immune system’s brakes on T-cells.

Triple-negative breast cancer accounts for about 10-15% of breast cancers and has the worst prognosis among breast cancer subtypes. The five-year survival rate for metastatic TNBC is approximately 12%, compared with 28% for other metastatic breast cancers. Few treatment options exist in the first-line setting beyond chemotherapy and Keytruda.

The FDA already approved Trodelvy for first-line TNBC in June 2026. The CHMP positive opinion paves the way for European Commission approval, which typically follows CHMP recommendations within 67 days. This expands Trodelvy’s revenue base beyond the US.

Context

Gilead acquired Trodelvy through its $21 billion Immunomedics acquisition in 2020, a deal widely criticized at the time for its price tag. The drug underperformed commercial expectations for years. The first-line TNBC approval in June 2026 and now the EU expansion mark a turning point. Gilead’s oncology franchise is building momentum, though HIV remains the company’s primary revenue driver with Q2 earnings expected August 4.

What to watch

The risk: Gilead faces a Leerink downgrade to Market Perform with a $127 price target, roughly 3% below the current price. Analysts question whether Trodelvy’s momentum justifies a higher multiple when the HIV franchise faces increasing competition from Gilead’s own lenacapavir and Merck’s pipeline. Watch the August 4 earnings call for management’s Trodelvy sales guidance and any update on the ASCENT-04 full data presentation at a medical meeting.

Sources: Gilead CHMP announcement, Finnhub coverage via Yahoo, FDA first-line TNBC approval context, Gilead lenacapavir HIV PrEP coverage