MSD and Gilead scrap Phase III Trodelvy-Keytruda study on lacklustre interim data
Merck & Co (MSD) and Gilead Sciences ended the Phase III KEYNOTE-D46/EVOKE-03 trial in frontline PD-L1-expressing NSCLC after an external data monitoring committee projected the Trodelvy (sacituzumab govitecan) plus Keytruda (pembrolizumab) would not significantly improve overall survival versus Keytruda alone. Trodelvy-Keytruda showed nonsignificant PFS benefit and no new safety issues. Trodelvy Q2 2026 sales rose 26% to $457m.
How this was made
The 30-second read
Why it matters
The external data monitoring committee predicted no significant overall survival improvement, leading to discontinuation. This reduces the probability of a new NSCLC combination label and shifts attention to other Trodelvy programs.
Market read
A Phase III NSCLC combination program is stopped for OS futility, a concrete negative catalyst for Trodelvy-Keytruda development expectations, while other trials remain active.
What to watch
The article says the result will not impact ongoing studies; traders may overreact to the NSCLC combo stop while underweighting ASCENT-05 (TNBC) and Trodelvy monotherapy late-stage programs (ES-SCLC, endometrial cancer).
Background
KEYNOTE-D46/EVOKE-03 (NCT05609968) tested Trodelvy (sacituzumab govitecan) plus Keytruda (pembrolizumab) versus Keytruda alone in frontline PD-L1-expressing NSCLC.
Ticker impact
Merck terminated the KEYNOTE-D46/EVOKE-03 Phase III Trodelvy plus Keytruda study after an external committee predicted no OS benefit vs Keytruda alone.
Near-term downside bias for Merck oncology sentiment, partially offset by continued Keytruda standalone momentum and other pipeline priorities.
The article discloses a specific Phase III stop driven by an OS futility/negative committee assessment, which typically reduces probability-weighted combo upside even if safety is unchanged.
Gilead scrapped the Phase III Trodelvy-Keytruda NSCLC study due to lack of significant overall survival improvement versus Keytruda alone.
Negative sentiment impact for Gilead, with traders likely refocusing on ASCENT-05 and Trodelvy monotherapy programs.
The discontinuation is tied to a committee verdict on OS, and the article frames it as a setback for Trodelvy’s commercial horizon, while noting ongoing studies are not impacted.
Market effects
Highlights ADC and checkpoint-combination trial risk, potentially pressuring sentiment around similar frontline NSCLC combo strategies.
Primarily US-listed biotech/oncology sentiment; limited direct regional spillover beyond pharma oncology complex.
US trial outcome affects global development probability for Trodelvy-Keytruda and informs broader ADC combo R&D risk appetite.
Counterpoint
Because the regimen was well tolerated and showed numerical PFS benefit, some investors may view the OS outcome as a specific design/endpoint miss rather than a total efficacy failure.
Key entities
- drugTrodelvy (sacituzumab govitecan)
Gilead’s antibody-drug conjugate evaluated in combination with Keytruda in the discontinued Phase III NSCLC trial.
- drugKeytruda (pembrolizumab)
Merck’s PD-1 therapy used as the control and backbone in the discontinued combination study.
- clinical trialKEYNOTE-D46/EVOKE-03 (NCT05609968)
Phase III study discontinued due to lack of significant OS benefit versus Keytruda alone.
- clinical trialASCENT-05 (NCT05633654)
Next referenced trial where Trodelvy and Keytruda are pitted against physician’s choice in high-risk adjuvant TNBC.
