Zongertinib Shows 76% Response Rate in HER2-Mutant NSCLC, Paving Way for Accelerated FDA Approval

Zongertinib achieved a 76% overall response rate and a median response duration of 15.2 months in treatment‑naïve patients with HER2‑mutant advanced or metastatic non‑small cell lung cancer. The data support an oral targeted alternative to chemotherapy and have enabled an accelerated FDA approval pathway.

In a separate study, abbreviated chemotherapy combined with brentuximab vedotin and nivolumab was tested in patients with non‑bulky early‑stage classical Hodgkin lymphoma. The regimen maintained high response rates across risk groups while omitting two chemotherapy agents and radiation, potentially reducing cumulative toxicity.

Additional research highlighted at MD Anderson included findings on epigenetic regulation of Dicer linking cell‑division control to infertility and cancer, the use of RF‑SIRF for single‑cell mapping of reversed replication forks to identify stress‑related epigenetic signatures, and a FLAG‑based regimen with gemtuzumab ozogamicin or idarubicin that delivered a 74% five‑year overall survival in CBF‑AML, with FLAG‑GO showing an 80% five‑year survival rate.