912P - Selection of personalized salvage treatments in advanced refractory head and neck squamous cell carcinomas via multi-omics tumor profiling

Background

Standard of care (SoC) systemic anticancer regimens may not be viable in some patients with advanced refractory head and neck squamous cell carcinomas (SCCHN), especially those with residual toxicities from prior failed regimens. In such cases, the treating oncologists often consider label-agnostic salvage regimens based on empirical evidence and experience.

Methods

We evaluated the safety and efficacy of Exacta® multi-omics tumor profiling (ETA: encyclopedic tumor analysis) guided personalized regimens in 32 patients (4 female, 27 male) patients from the RESILIENT n-of-1 study, with taxane- or platinum-refractory metastatic/non-resectable SCCHN. The median age of the cohort was 47 (range: 35-66) years. All patients presented with disease progression following the failure of 1-4 (median 2) prior systemic lines, apart from surgical resection and radiotherapy.

Results

ETA-guided personalized regimens included label-agnostic combinations of targeted and cytotoxic agents (n = 23) or cytotoxic agents (n = 8). Study treatments were well tolerated with transient (and clinically manageable) Grade III treatment-related adverse events (TRAE) being observed in 8 patients. ETA-guided treatments yielded a 48.4% objective response rate (ORR) and a 93.5% disease control rate (DCR) radiologically determined as per RECIST. The median progression-free survival (mPFS) was 5.7 (95% CI: 3.4 – 7.9) months which was 1.9x greater than the mPFS of the last (failed) systemic treatment. The median overall survival (mOS) was 9 months (95% CI: 6.1 - 12.5) with 3 patients having OS > 60 months.

Conclusions

Multi-omics tumor profiling (e.g, Exact®) can guide the selection of personalized (combination) salvage regimens that can be safe and efficacious for patients with advanced refractory SSCHN. This approach yields meaningful response and survival benefits and may restore the viability of further life-extending regimens.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Datar Cancer Genetics.

Funding

Datar Cancer Genetics.

Disclosure

D.S. Patil, N. Shrivastava, V. Mhase, S.B. Patil, V. Datta, R. Datar: Other, Institutional, Full or part-time Employment: Datar Cancer Genetics. All other authors have declared no conflicts of interest.