Which primary endpoints will AstraZeneca and Daiichi Sankyo report as met in the first topline announcement for the Phase 3 AVANZAR trial?
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Progression-free survival met in at least one population, overall survival not met or not yet mature
53.3%
As of 14 Oct 2026, 16:17 UTC
Outcome probabilities
Rationale
Full accessI give a 53% probability of progression-free survival success without significant overall survival at the first announcement, primarily because Kelun-Biotech reported a progression-free survival win in the similar OptiTROP-Lung06 trial.
Forecast breakdown
Full accessForecast record
Forecast context
AVANZAR is a Phase 3 trial of AstraZeneca and Daiichi Sankyo's TROP2-directed antibody-drug conjugate Datroway (datopotamab deruxtecan) plus Imfinzi and platinum chemotherapy, against Keytruda plus chemotherapy, in roughly 1,350 patients with previously untreated advanced non-small cell lung cancer without actionable genomic alterations. Its dual primary endpoints are progression-free survival and overall survival, each assessed in non-squamous patients who are TROP2-positive by AstraZeneca's AI-based Quantitative Continuous Scoring (QCS) biomarker and in all non-squamous patients. The earlier TROPION-Lung01 trial of Datroway improved progression-free survival but missed on overall survival; a retrospective analysis suggested a larger benefit in QCS-positive patients, which led to the biomarker-defined design. The readout has been delayed twice because of slower than expected event accrual; analysts expected topline results around November or December 2026. Overall survival is the key regulatory hurdle, as the FDA has increasingly expected survival evidence for first-line lung cancer regimens.
Clarifications
This question resolves based on the first official topline announcement of AVANZAR primary-endpoint results by AstraZeneca and/or Daiichi Sankyo (press release or regulatory filing). An endpoint counts as met only if the sponsor states it reached statistical significance under the trial's pre-specified analysis.
Resolve to the first category that applies, in this order:
- 'Overall survival met in the full non-squamous population' if statistically significant overall survival is reported in the full non-squamous population (whether or not it is also met in the TROP2 QCS-positive population).
- 'Overall survival met in the TROP2 QCS-positive population only' if statistically significant overall survival is reported in the TROP2 QCS-positive non-squamous population but not in the full non-squamous population.
- 'Progression-free survival met in at least one population, overall survival not met or not yet mature' if progression-free survival is statistically significant in either population and overall survival is not reported as statistically significant in either population, including when overall survival is described as immature, still being followed, or continuing to a later analysis.
- 'No primary endpoint met' if neither progression-free survival nor overall survival is statistically significant in either population.
Later analyses after the first topline announcement do not change the resolution. If the trial is discontinued without any primary-endpoint results being announced, the question is annulled.
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