ESMO 2025 preview – Enhertu's early breast hat-trick
The ESMO presidential session will feature data from Destiny-Breast05 and 11.
The ESMO presidential session will feature data from Destiny-Breast05 and 11.
2025 was expected to be the year when Enhertu could lay the groundwork to become the $5bn-plus drug it has long been projected to be, and it seems to have delivered. AstraZeneca and Daiichi Sankyo have toplined Destiny-Breast05, the trial evaluating Enhertu versus Kadcyla in adjuvant HER2-positive breast cancer as positive.
As if this weren't enough of a success, the data are also to be featured in the presidential symposium at ESMO, which begins in just three weeks. ESMO has given the trial a last-minute late-breaker slot, meaning that it has given three Enhertu studies a high profile.
The first presidential session, on 18 October, will now feature Destiny-Breast05 as well as Destiny-Breast11, a neoadjuvant trial, though the latter isn't technically a late-breaker. Meanwhile, subgroup data from Destiny-Breast09 have secured a late-breaker slot in regular oral sessions.
Highly stat sig
According to the companies, Destiny-Breast05 showed a “highly statistically significant and clinically meaningful improvement in invasive disease-free survival”. While the results strengthen Enhertu’s case in earlier-stage disease, questions remain about the risk of interstitial lung disease in the relatively large adjuvant setting, where patients are generally healthier and face long treatment durations.
It was already known that Destiny-Breast11 data would feature in ESMO's presidential session. That study read out positively three weeks before ASCO but the companies have so far kept back the full data.
Meanwhile, Destiny-Breast09 took the spotlight at ASCO, where Enhertu impressed with a 44% reduction in the risk of progression in first-line disease, reinforcing the drug's potential to expand into earlier lines in HER2-positive breast cancer. The companies have submitted these data to the FDA, with a PDUFA date set for January 2026.
Along with the results from Destiny-Breast05 and 11, the study could help Enhertu reach an additional 84,000 patients on top of the 17,000 currently treated, according to AstraZeneca's projections from earlier this year.
Notable breast cancer presentations at ESMO 2025
| Trial | Setting | Regimen | Note | ESMO abstract |
|---|---|---|---|---|
| Destiny-Breast05 | Adjuvant HER2+ve early breast cancer (following neoadjuvant therapy) | vs Kadcyla | Toplined positive in Sep 2025 | LBA1 (presidential session) |
| Destiny-Breast11 | Neoadjuvant HER2+ve early breast cancer | +/- paclitaxel + Herceptin + Perjeta, vs chemo + paclitaxel + Herceptin + Perjeta | Toplined positive in May 2025 | 291O (presidential session) |
| Destiny-Breast09 | 1st-line HER2+ve metastatic breast cancer | +/- Perjeta, vs chemo + Herceptin + Perjeta | Data presented at ASCO 2025; PDUFA date 23 Jan 2026 | LBA18 |
| Optitrop-Breast02* | 2nd-line HER2-negative breast cancer | Vs physician’s choice | Toplined positive in May 2025 | LBA23 |
Note: *sacituzumab tirumotecan trial. Source: OncologyPipeline.
ESMO will take place in Berlin on 17-21 October.
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