ESMO 2025 Preview: Astra and Daiichi vs. Gilead
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As ESMO 2025 approaches, Astra and Daiichi are positioning themselves against Gilead. This article analyzes the implications for investors and pharma teams.
Oncology headlines at ESMO 2025 centered on first-line metastatic triple-negative breast cancer, where AstraZeneca–Daiichi Sankyo's Datroway and Gilead's Trodelvy each beat chemotherapy in Phase 3. Investors now weigh overall survival claims against progression-free gains in similar but not identical populations.
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Key Takeaways
- Datroway (TROPION-Breast02, LBA21): OS HR 0.79; median OS 23.7 vs 18.7 months; PFS HR 0.57; median PFS 10.8 vs 5.6 months.
- Trodelvy (ASCENT-03, LBA20): PFS HR 0.62; median PFS 9.7 vs 6.9 months in 558 patients not candidates for PD-(L)1 inhibitors.
- Enhertu early-breast DESTINY-Breast11 and DESTINY-Breast05 featured in Presidential Symposium coverage from Daiichi Sankyo/AstraZeneca.
- Neither readout alone settles US/EU label timing or cross-ADC superiority.
What did Datroway show in TROPION-Breast02?
According to the Daiichi Sankyo Business Wire on TROPION-Breast02, Datroway met dual primary OS and PFS endpoints versus investigator's choice chemotherapy in locally recurrent inoperable or metastatic TNBC when immunotherapy was not an option.
Median OS improved by 5.0 months (23.7 vs 18.7 months; HR 0.79; 95% CI 0.64–0.98; p=0.0291). Median PFS was 10.8 versus 5.6 months (HR 0.57; 95% CI 0.47–0.69; p<0.0001) by blinded independent central review.
How did Trodelvy's ASCENT-03 counter?
Gilead's ASCENT-03 Business Wire reported a 38% reduction in disease progression or death versus chemotherapy (HR 0.62; p<0.0001), with median PFS 9.7 versus 6.9 months.
The global open-label Phase 3 trial enrolled 558 patients with previously untreated advanced TNBC whose tumors do not express PD-L1, or who are PD-L1 positive and previously received a PD-(L)1 inhibitor in the curative setting. Results were presented as LBA20 and published simultaneously in the New England Journal of Medicine, per the release.
Where else did AstraZeneca–Daiichi push oncology?
A separate Daiichi Sankyo ESMO preview wire highlighted DESTINY-Breast11 (291O) and DESTINY-Breast05 (LBA1) for Enhertu in HER2-positive early breast cancer during Presidential Symposium I, plus the Datroway late-breaker.
That breadth matters for franchise valuation: early curative Enhertu settings and first-line TROP2 TNBC are different payer and guideline conversations than late-line ADC use.
What should BD and competitive intelligence teams do now?
Map trial eligibility side by side before declaring a winner. Datroway's OS win is a high bar in immunotherapy-ineligible TNBC; Trodelvy's PFS win in ASCENT-03 still needs mature OS and label strategy for first-line use.
- Track regulatory submissions citing TROPION-Breast02 and ASCENT-03.
- Model sequencing if both gain first-line labels in overlapping markets.
- Separate early-breast Enhertu readouts from metastatic TROP2 contests.
What remains unproven after ESMO 2025?
Congress presentations do not equal approvals. Cross-trial comparisons are confounded by inclusion criteria, chemotherapy controls, and follow-up maturity. Safety profiles, dosing convenience, and real-world adherence will decide share if both regimens reach guidelines.
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- Datroway vs Trodelvy First-Line TNBC Battle
Frequently Asked Questions
What oncology ADC data defined ESMO 2025 for AstraZeneca and Daiichi?
TROPION-Breast02 showed Datroway improved median OS by 5.0 months versus chemotherapy (HR 0.79; 23.7 vs 18.7 months) and cut progression or death risk by 43% (PFS HR 0.57; median PFS 10.8 vs 5.6 months) in first-line metastatic TNBC ineligible for immunotherapy.
How did Gilead's Trodelvy perform in ASCENT-03 at ESMO 2025?
ASCENT-03 met its primary PFS endpoint with a 38% reduction in progression or death risk versus chemotherapy (HR 0.62), and median PFS of 9.7 versus 6.9 months, in 558 patients with previously untreated metastatic TNBC who were not candidates for PD-1/PD-L1 inhibitors.
Do these ESMO readouts prove one TROP2 ADC is superior?
No. The trials enrolled overlapping but not identical first-line TNBC populations and used different designs; cross-trial ranking is not established without head-to-head evidence or regulatory labels covering these settings.
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