Cullinan's lung cancer drug clears Phase 3 trial

Some lung cancers carry a specific gene mutation called EGFR exon 20 insertion. Patients with it don't respond as well to standard first-choice drugs. Cullinan Therapeutics and its partner Taiho built zipalertinib specifically for that harder-to-treat group. On Wednesday, they said a large trial of zipalertinib plus chemotherapy met its main goal. That goal: slowing the cancer's growth.

This win isn't final yet. The results come from a planned interim analysis, a scheduled early look while the trial is still running. Full data and regulatory review still have to happen before doctors can prescribe it. The current go-to drug for this mutation is Johnson & Johnson's Rybrevant, an infusion that already has FDA approval. Zipalertinib is a pill, not an infusion. If it holds up through full trials, that convenience alone could pull patients away from Rybrevant.

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Will zipalertinib's advantage hold up in the final data? Interim results sometimes look better than the final numbers turn out to be. Cullinan and Taiho now have to run the trial to completion. Then they have to file for approval, which can take a year or more. Investors are already reacting: Cullinan is in line for a $100 million payment tied to this result. The real test is whether the drug still beats Rybrevant once every patient's data is in.