Merus’ Zenocutuzumab Receives the US FDA’s Breakthrough Therapy Designation for NRG1 Fusion Non-Small Cell Lung Cancer
Shots:
- The US FDA has granted BTD to zenocutuzumab for advanced unresectable or metastatic NRG1 fusion (NRG1+) NSCLC, following progression with prior systemic therapy
- The BTD was based on an ongoing P-I/II trial (eNRGy) and Early Access Program evaluating zenocutuzumab monotx. in NRG1+ cancer. In the (eNRGy) trial, investigator-assessed ORR (34%) after a median follow-up of 6.3mos. among all evaluable patients, the median time to response was 1.8mos., and m-DoR was 9.1mos., any-grade TRAEs (61%) incl. grade 3/4 TRAEs in 5%
- The company plans to provide a clinical update on zenocutuzumab in NRG1+ cancer at a major medical conference in 2023 & is expected to provide initial clinical data on zenocutuzumab in H2’23 for CRPC
Ref: Globenewswire | Image: Merus
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