ESMO 2023 – Amgen keeps tarlatamab filing plans under wraps

Amgen impressed at ESMO today with full data on tarlatamab in third-line or later small-cell lung cancer – but it's still unclear whether the DLL3-targeting project can get approved on the available evidence. The data, also published in NEJM, come from the phase 2 Dellphi-301 study, which Amgen has described as “potentially registrational”. But the trial is uncontrolled, and the company already has a phase 3 study under way comparing tarlatamab against standard of care. All Amgen would tell ApexOnco is that it is “actively discussing” the latest results with the FDA and other regulators. A strange feature of the data was that the 10mg dose outperformed 100mg, something that Evercore ISI's Jon Miller suggested could be down to losing the ability to form a ternary complex at high doses. In any case Amgen is now focused on 10mg. Today’s presentation also shed more light on adverse events, including one treatment-related death from respiratory failure in the 10mg group. Presenting the results, Dr Luis Paz-Ares of Hospital Doce de Octubre said toxicity was “manageable”, but the discussant, Dr Pilar Garrido of Hospital Universitario Ramón y Cajal, highlighted the need for in-patient monitoring. 

Notable trials of tarlatamab

Source: Amgen, OncologyPipeline.

This story has been updated with comments from Evercore ISI.