KEY TAKEAWAYS
- The phase I trial aimed to evaluate the safety and efficacy of a new drug for relapsed T-cell lymphoma, especially at the highest dose without another drug.
- The primary endpoint was to measure the MTD. Secondary endpoints include the safety and efficacy of VSV-IFNβ-NIS.
- The study found that the drug was safe and effective for treating PTCL.
Oncolytic virotherapy is a cancer therapy that kills the cancer cells with viruses. Researchers aimed to evaluate the safety and efficacy of a new drug for relapsed T-cell lymphoma, especially at the highest dose without another drug.
The study used a 3+3 design; VSV-IFNβ-NIS was given as a single IV dose, starting at 5e9 TCID50 DL1 and escalating to 1.7e11 TCID50 DL4. An additional 8 pts with relapsed/refractory TCL were included at DL4 due to initial signs of effectiveness. The primary endpoint was identifying the maximum tolerated dose (MTD) as a standalone treatment. Secondary endpoints included assessing safety and initial effectiveness. Adverse events(AEs) were documented following CTCAE V4 guidelines, and cytokine release syndrome (CRS) grading followed Lee’s criteria.
Of 43 pts received VSV-IFNβ-NIS for multiple myeloma (MM), T-cell lymphoma (TCL), and acute myeloid leukemia (AML). In the TCL group at DL4 (Group A, without Ruxolitinib), 11 out of 12 registered pts were treated with various TCL subtypes. They had received a median of 3 prior treatments. No dose-limiting toxicities (DLTs) were observed. Common grade 3 or higher AEs were hematologic, transient lymphopenia (63.6%), and neutropenia (36.4%). Non-hematologic AEs included CRS (grades 1-2: 81.8%), transient transaminitis (grades 1-2: 36.4%, grade 3: 27.3%), and thrombocytopenia (grades 1-2: 63.6%, grade 3: 18.2%), primarily due to IFNβ. These AEs were short-lived. Some positive responses were observed, particularly in systemic PTCL, with 5 responses, including 3 complete responses (2 of which were long-lasting) and 2 partial responses at DL4.
The study found that a single dose of a new virus-based drug is safe and effective for treating patients with PTCL, a type of blood cancer. The drug is being studied further to learn more about its safety, effectiveness, and how it works.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.7530
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03017820
Nabila Nora Bennani, Joselle Cook, Kah-Whye Peng, Susan Michelle Geyer, Brenda F. Ginos, Lianwen Zhang, Sharina C. Macapagal, Thomas E. Witzig, Javier Munoz, Stephen M Broski, Stephen J. Russell, and Martha Lacy. DOI: 10.1200/JCO.2023.41.16_suppl.7530 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 7530-7530.
