Mark Schwartz

Mark Schwartz asked about the rationale behind including an interim PFS analysis for the HARMONi-3 squamous cohort, expectations for the Q2 data readout, and the potential for overall survival (OS) to reach statistical significance by the final PFS analysis.

Answer

Dave Gancarz, Chief Business and Strategy Officer, explained that the decision was data-backed by positive interim readouts from HARMONi-2 and HARMONi-6, aiming to accelerate regulatory discussions. He noted that OS data would be immature at the interim PFS analysis and that the company does not guide on numerical expectations. Allen Yang, Chief R&D Strategy Officer, added that the goal is to bring the medicine to patients faster.

Mark Schwartz inquired about the rationale behind including an interim PFS analysis for the HARMONi-3 squamous cohort, seeking clarity on expectations for initial data in Q2 and final PFS/interim OS in H2, and whether OS could achieve statistical significance by the final PFS analysis.

Answer

Dave Gancarz, Chief Business and Strategy Officer, explained that the decision to add an interim PFS analysis was driven by positive interim readouts from HARMONi-2 (PFS HR 0.51) and HARMONi-6 (PFS HR 0.60), aiming to accelerate timelines and regulatory discussions. He noted that overall survival (OS) would be immature at the interim PFS analysis. Allen Yang, Chief R&D Strategy Officer, reiterated that it was a data-backed decision to bring the medicine to patients faster. No specific statistical plan details were provided.