Encyclopedic tumor analysis for guiding treatment of advanced, broadly refractory cancers: results from the RESILIENT trial
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Rajnish Nagarkar1, Darshana Patil2, Timothy Crook3, Vineet Datta2, Sagar Bhalerao1, Sonal Dhande1, Vijay Palwe1, Shirsendu Roy1, Prakash Pandit1, Ashwini Ghaisas2, Raymond Page4, Harjeetsingh Kathuria1, Ajay Srinivasan2 and Dadasaheb Akolkar2
1 HCG Manavata Cancer Centre, Nasik, India
2 Datar Cancer Genetics Limited, Nasik, India
3 St. Luke’s Cancer Center, Royal Surrey County Hospital, Guildford, UK
4 Worcester Polytechnic Institute, Worcester, USA
|Ajay Srinivasan,||email:||[email protected]|
Keywords: precision oncology; encyclopedic tumor analysis; personalized cancer treatment; objective response rate; progression free survival
Received: April 09, 2019 Accepted: August 16, 2019 Published: September 24, 2019
RESILIENT (CTRI/2018/02/011808) was a single arm, open label, phase II/III study to test if label agnostic therapy regimens guided by Encyclopedic Tumor Analysis (ETA) can offer meaningful clinical benefit for patients with relapsed refractory metastatic (r/r-m) malignancies. Patients with advanced refractory solid organ malignancies where disease had progressed following ≥2 lines of systemic treatments were enrolled in the trial. Patients received personalized treatment recommendations based on integrational comprehensive analysis of freshly biopsied tumor tissue and blood. The primary end points were Objective Response Rate (ORR), Progression Free Survival (PFS) and Quality of Life (QoL). Objective Response (Complete Response + Partial Response) was observed in 54 of 126 patients evaluable per protocol (ORR = 42.9%; 95% CI: 34.3%–51.4%, p < 0.0001). At study completion, Disease Control (Complete Response + Partial Response + Stable Disease) was observed in 114 out of 126 patients evaluable per protocol (CBR = 90.5%; 95% CI: 83.9% - 95.0%, p < 0.00001) and Disease Progression in 12 patients. Median duration of follow-up was 138 days (range 31 to 379). Median PFS at study termination was 134 days (range 31 to 379). PFS rate at 90 days and 180 days were 93.9% and 82.5% respectively. The study demonstrated that tumors have latent vulnerabilities that can be identified via integrational multi-analyte investigations such as ETA. This approach identified viable treatment options that could yield meaningful clinical benefit in this cohort of patients with advanced refractory cancers.
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