Feasibility, safety, and efficacy of stereotactic body radiotherapy combined with intradermal heat-killed mycobacterium obuense (IMM-101) vaccination for non-progressive locally advanced pancreatic cancer, after induction chemotherapy with (modified)FOLFIRINOX: the LAPC-2 trial

va't Land, F.R.; Latifi, D.; Moskie, M.; Homs, M.Y.V.; Bosscha, K.; Bonsing, B.A.; ... ; South West Pancreatic Canc Care SW (2023)

Article / Letter to editor

Background and purpose: In this phase I/II trial, non-progressive locally advanced pancreatic cancer (LAPC) patients after (modified)FOLFIRINOX therapy were treated with stereotactic body radiotherapy (SBRT) combined with heat-killed mycobacterium (IMM-101) vaccinations. We aimed to assess safety, feasibility, and efficacy of this treatment approach.Materials and methods: On five consecutive days, patients received a total of 40 Gray (Gy) of SBRT with a dose of 8 Gy per fraction. Starting two weeks prior to SBRT, they in addition received six bi-weekly intradermal vaccinations with one milligram of IMM-101. The primary outcomes were the number of grade 4 or higher adverse events and the one-year progression free-survival (PFS) rate. Results: Thirty-eight patients were included and started study treatment. Median follow-up was 28.4 months (95 %CI 24.3 - 32.6). We observed one grade 5, no grade 4 and thirteen grade 3 adverse events, none related to IMM-101. The one-year PFS rate was 47 %, the median PFS was 11.7 months (95 %CI 11.0 - 12.5) and the median overall survival was 19.0 months (95 %CI 16.2 - 21.9). Eight (21 %) tumors were resected, of which 6 (75 %) were R0 resections. Outcomes were comparable with the outcomes of the patients from the previous LAPC-1 trial, in which LAPC patients were treated with SBRT, without IMM-101.Conclusion: Combination treatment with IMM-101 and SBRT was safe and feasible for non-progressive locally advanced pancreatic cancer patients after (modified)FOLFIRINOX. No improvement in the progression-free survival could be demonstrated by adding IMM-101 to SBRT.(c) 2023 Published by Elsevier B.V. Radiotherapy and Oncology 183 (2023) 109541

• Locally advanced pancreatic cancer
• Pancreatic ductal adenocarcinoma
• Stereotactic body radiotherapy
• Heat -killed mycobacterium obuense
• IMM-101
• Immuno-oncology

• All authors: va't Land, F.R.; Latifi, D.; Moskie, M.; Homs, M.Y.V.; Bosscha, K.; Bonsing, B.A.; Mieog, S.D.; Harst, E. van der; Coene, P.P.L.O.; Wijsman, J.H.; Schelling, G.P. van der; Koerkamp, B.G.; Nuyttens, J.J.; Eijck, C.H.J. van; South West Pancreatic Canc Care SW
• Date: 2023-03-10
• Journal: Radiotherapy & Oncology
• Volume: 183
• DOI: doi:10.1016/j.radonc.2023.109541
• Link: https://www.sciencedirect.com/science/article/pii/S0167814023000798?via%...