The Lung Cancer Genomic Screening Project for Individualized Medicine in Asia (LC-SCRUM-Asia) has partnered with Thermo Fisher Scientific Inc. to speed molecular profiling in two major studies. The project now uses Waltham, Mass.-based Thermo Fisher’s Ion Torrent Genexus system and Oncomine Precision assay as the sole system for conducting next-generation sequencing (NGS) to improve personalization of therapeutic approaches and better understand drug resistance in non-small-cell lung cancer (NSCLS).

LC-SCRUM-Japan began in 2013 and became LC-SCRUM-Asia in May 2019, when it expanded its network to include Taiwan’s Chang Gung Memorial Hospital and adopted a more regional approach to screening for treatment target genes and development of novel therapeutics for lung cancer. In total, the project has enrolled nearly 11,000 patients in the program to demonstrate the clinical value of molecular profiling for patient clinical trial enrollment. Now in phase III, LC-SCRUM-Asia has been using both multi-PCR assay using Amoy 9+1 as well as NGS with Oncomine Comprehensive assay to manage turnaround time.

The dual systems made sense for years. “PCR can return results in one week but with limited information and NGS can return results in two weeks but with more comprehensive information,” Luca Quagliata, vice president, medical affairs for clinical next-generation sequencing at Thermo Fisher Scientific, told BioWorld.

Thermo Fisher’s newest system made maintaining a dual track program unnecessary and provided the quick results LC-SCRUM’s leadership needed as the number of patients and targetable mutations increased. “With Genexus, there is no need to trade-off between turnaround time and comprehensive molecular profiling. With Genexus’ automated solution and one-day turnaround time, comprehensive NGS results can be generated as the same time, if not faster than PCR results.”

LC-SCRUM-TRY trial design. Credit: Thermo Fisher Scientific Inc. and LC-SCRUM-Asia

A new study within the SCRUM program, LC-SCRUM-TRY, launched on Sept. 29. TRY focuses specifically on monitoring resistance to therapy using tissue and liquid NGS. That study will also use the Oncomine Precision assay on the Genexus system for sequencing.

“The speed of NGS-based molecular profiling tests is becoming increasingly important. We believe these solutions, designed to deliver results quickly, will transform the field of precision oncology,” said Koichi Goto, chief of the Department of Thoracic Oncology, National Cancer Center Hospital East, who is leading the cancer clinical trials.

The studies

The studies are coordinated by the National Cancer Center of Japan in collaboration with more 200 Japanese cancer hospitals, university hospitals, medical institutions in Asia, and pharmaceutical companies.

LC-SCRUM-Asia plans to enroll an additional 4,000 participants each year for the next five years, with 3,000 patients coming from Japan and 1,000 each year coming for other Asian countries. TRY investigators expect to enroll 10,000 patients in the study over the next five years.

LC-SCRUM initially conducted genome screening for just three targets: RET, ROS1, and ALK fusion genes. In 2015, the project began using the Oncomine Comprehensive assay to screen for EGFR mutation-negative NSCLC patients. With the Oncomine Precision assay, the project will be able to detect more than 50 cancer-related biomarkers in both formalin-fixed paraffin-embedded (FFPD) tissue samples and liquid biopsy specimens.

The partnership

Thermo Fisher and LC-SCRUM also collaborated on a clinical study for the Oncomine Dx Target test. Results of the trial were critical to the Dx Target test gaining approval as the first NGS companion diagnostic from Japan’s Pharmaceutical and Medical Devices Agency in 2019. The test can simultaneously detect multiple biomarkers associated with NSCLC.

With the adoption of the Oncomine Precision assay and the Genexus system in the LC-SCRUM programs, Thermo Fisher and LC-SCRUM have an opportunity to take the Precision assay through PMDA submission as another NGS companion diagnostic for routine clinical testing, Quagliata noted.

“Through our valued partnership with LC-SCRUM, Dr. Goto and his team have a pivotal opportunity to advance precision medicine for non-small-cell lung cancer in Asia,” said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. “Expanding access to comprehensive genomic profiling will help improve the future standard of care.”

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