Memorial Sloan Kettering Cancer Center

FDA granted accelerated approval to zenocutuzumab (Bizengri) for NRG1 gene fusion-positive pancreatic adenocarcinoma and non-small cell lung cancer (NSCLC). The therapy targets HER2 and HER3, addressing advanced, unresectable, or metastatic disease that progressed on prior systemic therapy. Results from the eNRGy study showed a third of NSCLC patients and 40% of pancreatic cancer patients responded, with median duration of response of 7.4 months and 3.7 to 16.6 months, respectively. Common adverse events included diarrhea, musculoskeletal pain, and fatigue.

Merus announces FDA approval of BIZENGRI® (zenocutuzumab-zbco) for NRG1+ pancreatic adenocarcinoma and NRG1+ NSCLC, based on eNRGy trial results showing 40% overall response rate in pancreatic cancer and 33% in NSCLC. The drug's duration of response ranges from 3.7 to 16.6 months in pancreatic cancer and 7.4 months in NSCLC. Approval is under the accelerated pathway, pending confirmatory trials, and BIZENGRI® is expected to be available to patients soon, with the PTx Assist™ program offering support.

Treovir, Inc. opens Phase 2 trial for G207, an oncolytic HSV immunotherapy, in pediatric brain tumor patients. The trial, conducted with the Pediatric Brain Tumor Consortium, aims to evaluate efficacy and safety. Treovir anticipates additional enrollment sites in late 2024 and 2025, with Phase 2 data supporting a BLA filing for G207 market approval.

FDA approves zenocutuzumab for NRG1+ NSCLC and PDAC, supported by phase 1/2 eNRGy trial. It's the first targeted therapy for these cancers, with ORR of 33% in NSCLC and 40% in PDAC.

2024 saw transformative advances in oncology, including improved liquid biopsy assays, AI-driven diagnostics, and expanded use of CDK4/6 inhibitors, antibody-drug conjugates, and immunotherapies. Notable approvals included ribociclib for high-risk breast cancer, T-DXd for HER2-low breast and gastric cancers, and tisotumab vedotin-tftv for cervical cancer. Molecular therapies like lazertinib and amivantamab-vmjw for NSCLC, and selpercatinib for medullary thyroid cancer, also advanced. Lifestyle interventions and metabolic therapies showed potential in improving quality of life and anticancer effects.

The CEPHEUS trial showed that adding daratumumab to VRd significantly improved MRD negativity and complete response rates in transplant-ineligible NDMM patients. The quadruplet regimen achieved a 60.9% MRD negativity rate vs. 39.4% with VRd alone, with superior sustained MRD negativity and progression-free survival. These results support the use of daratumumab in frontline treatment for this patient population.

85% of patients with low-grade UTUC achieved CR after Padeliporfin VTP treatment; therapy remains safe and effective.

85% of evaluable patients with low-grade UTUC achieved complete response (CR) after Padeliporfin VTP treatment in the Induction Treatment Phase. Padeliporfin VTP continues to show safety and efficacy, with a consistent safety profile and no Grade 4 or 5 adverse events. ImPact Biotech plans to complete ENLIGHTED study enrollment by early 2025.

In a study of RCC patients on clinical trials using TM, 67% preferred in-person care, 64% found TM equal in quality, and 97% had positive/neutral TM experiences. Providers preferred in-person visits and rated TM quality lower, yet most had positive TM experiences. Further evaluation is needed for TM integration in clinical trial care.