KEY TAKEAWAYS
- An ongoing phase I/II trial assessed the safety & early anti-tumor effects of TAC01-HER2 in HER2+ tumors.
- The TAC01-HER2 treatment demonstrated manageable safety, encouraging efficacy in heavily treated cancers.
In an ongoing phase I/II trial, researchers investigated TAC01-HER2’s safety and anti-tumor effects in HER2+ solid tumors. The patients (pts) received leukapheresis and low-intensity lymphodepletion chemotherapy before the TAC01-HER2 infusion.
Phase I involved dose escalation (Cohorts 1–4) in adults who’ve had ≥2 prior therapies. The dose-limiting toxicity (DLT) was assessed within 28 days post-infusion. Phase II will expand on the optimal TAC01-HER2 dose, focusing on efficacy, safety, and drug behavior in gastric/GEJ tumors.
By June 5, 2023, 20 pts with solid tumors received treatment in Cohorts 1–4. Three pts had HER2 1+ or 2+/FISH-. In Cohort 4, one patient experienced a grade (G) 3 pneumonitis, classified as DLT. No neurotoxicity was reported.
Most Cohorts 3–4 pts experienced manageable cytokine release syndrome (CRS), resolved with supportive care. Thirteen pts reported 26 serious adverse events, including 1 G3 pneumonitis, 4 CRS cases (1 G1, 3 G2, and 1 G3), and 1 TAC01-HER2-related G3 bronchial hyperreactivity.
After initial restaging following TAC01-HER2 infusion, Cohorts 2–4 showed a 67% disease control rate (DCR). In gastric/GEJ patients from the same cohorts, DCR reached 83%. Three months post-infusion, DCR was 33.3% for all Cohorts 2–4 patients and 50% for gastric/GEJ patients. Two patients experienced a partial response (PR).
A patient in Cohort 4 with GEJ (HER2 2+, FISH+) showed a 100% reduction in target lesion with a PR after progressing through four prior lines of therapy, including trastuzumab and trastuzumab deruxtecan.
TAC01-HER2 treatment demonstrated manageable safety and promising results in heavily treated cancer patients. Dose level 4 (6–8 x 106 cells/kg) was recommended for phase 2.
Source: https://jitc.bmj.com/content/11/Suppl_1/A745
Clinical Trial: https://clinicaltrials.gov/study/NCT04727151
Olson DJ, Dumbrava E, George M, et al654 A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumorsJournal for ImmunoTherapy of Cancer 2023;11:doi: 10.1136/jitc-2023-SITC2023.0654.
