OncLive® On Air S12 Ep1: FDA Approval Insights: Zenocutuzumab for NRG1+ Pancreatic Adenocarcinoma and NSCLC: With Alison Schram, MD
Jan 2, 2025
05:59
In today’s episode, supported by Merus, we had the pleasure of speaking with Alison Schram, MD, about the FDA approval of zenocutuzumab-zbco (Bizengri) for patients with previously treated advanced pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) harboring NRG1 gene fusions. Dr Schram is an assistant attending physician at Memorial Sloan Kettering Cancer Center in New York, New York.
On December 4, 2024, the FDA granted accelerated approval to zenocutuzumab for the treatment of adult patients with advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion who have disease progression on or after prior systemic therapy; and adult patients with advanced, unresectable, or metastatic NSCLC harboring an NRG1 gene fusion who have disease progression on or after prior systemic therapy. This regulatory decision was based on findings from the phase 2 eNRGy trial (NCT02912949), in which patients with pancreatic adenocarcinoma (n = 30) achieved an overall response rate (ORR) of 40% (95% CI, 23%-59%), and a duration of response (DOR) that ranged from 3.7 months to 16.6 months. In the NSCLC cohort (n = 64), the (ORR) of 33% (95% CI, 22%-46%), and the median DOR was 7.4 months (95% CI, 4.0-16.6).
In our exclusive interview, Dr Schram discussed the significance of this approval, key efficacy data from the pancreatic cancer and NSCLC cohorts of eNRGy, and the importance of using RNA-based testing to identify patients with NRG1 fusions.
On December 4, 2024, the FDA granted accelerated approval to zenocutuzumab for the treatment of adult patients with advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring an NRG1 gene fusion who have disease progression on or after prior systemic therapy; and adult patients with advanced, unresectable, or metastatic NSCLC harboring an NRG1 gene fusion who have disease progression on or after prior systemic therapy. This regulatory decision was based on findings from the phase 2 eNRGy trial (NCT02912949), in which patients with pancreatic adenocarcinoma (n = 30) achieved an overall response rate (ORR) of 40% (95% CI, 23%-59%), and a duration of response (DOR) that ranged from 3.7 months to 16.6 months. In the NSCLC cohort (n = 64), the (ORR) of 33% (95% CI, 22%-46%), and the median DOR was 7.4 months (95% CI, 4.0-16.6).
In our exclusive interview, Dr Schram discussed the significance of this approval, key efficacy data from the pancreatic cancer and NSCLC cohorts of eNRGy, and the importance of using RNA-based testing to identify patients with NRG1 fusions.