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NIH Launches 3 Integrated Precision Medicine Trials

Published: Wednesday, August 20, 2014
Last Updated: Wednesday, August 20, 2014
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Findings to answer questions about addition of targeted therapies in earlier stage disease and help understand the prevalence and natural history of these genomic changes in earlier stage lung cancer.

The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, was launched today to identify early-stage lung cancer patients with tumors that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against those changes can lead to improved survival.

“We believe that the findings from ALCHEMIST will not only help answer an important question about the addition of targeted therapies in earlier stage disease but will also help us in understanding the prevalence and natural history of these genomic changes in earlier stage lung cancer. We also hope to gain a better understanding as well regarding the genetic changes in the tumor at the time of recurrence,” said Shakun Malik, M.D., head of Thoracic Cancer Therapeutics in the Clinical Investigations Branch of the National Cancer Institute (NCI). “The findings will help to define clinical, biologic and molecular behaviors of this type of lung cancer.”

ALCHEMIST is supported by the NCI, part of the National Institutes of Health, with coordination of the component trials by the Alliance for Clinical Trials in Oncology and the ECOG-ACRIN Cancer Research Group. All of the NCI-supported National Clinical Trials Network (NCTN) groups collaborated in the development of ALCHEMIST and are participating in the component trials.

People enrolled in ALCHEMIST will need to undergo surgical removal of their tumors; have been diagnosed with lung adenocarcinoma or similar types of lung cancer as identified by examining the tissue; and will need to complete standard therapy after surgery, consisting of chemotherapy with or without radiation therapy as prescribed by their physician.

In the ALCHEMIST screening trial, the surgically removed tissue will be tested in a central laboratory for certain genetic changes in two genes, ALK and EGFR. Participants with tumors found to harbor EGFR mutations or rearrangement of the ALK gene will then be referred to one of two randomized, placebo-controlled ALCHEMIST treatment trials. These studies will evaluate the value of adding therapy with specific agents targeted against two genetic alterations, erlotinib (EGFR) and crizotinib (ALK), in the post-operative setting. The U.S. Food and Drug Administration has approved these drugs for the treatment of patients with advanced forms of lung cancer whose tumors harbor the targeted genetic alterations. However, it is not known if these agents will be beneficial when administered to patients who are clinically free of disease. The goal of the trials is to determine whether erlotinib or crizotinib will prevent lung cancer recurrence, as well as prolong life, when used against tumors that carry specific mutations.

The three component trials of ALCHEMIST are:

• ALCHEMIST - Screening component (A151216)– Coordinated by the Alliance for Clinical Trials in Oncology; Principal Investigators: Pasi A. Janne, M.D., Ph.D., and Geoffrey Oxnard, M.D., Dana-Farber Cancer Institute, Boston.

• ALCHEMIST - EGFR Treatment component (A081105) – Coordinated by the Alliance for Clinical Trials in Oncology; Principal Investigator: Ramaswamy Govindan, M.D., Washington University, St. Louis.

• ALCHEMIST - ALK Treatment component (E4512)– Coordinated by ECOG-ACRIN; Principal Investigator: David E. Gerber, M.D., University of Texas Southwestern Medical Center at Dallas.

Alterations in EGFR and ALK genes are not common. In the United States, about 10 percent of patients with lung adenocarcinoma and similar types of lung cancer will have tumors with alterations in the EGFR gene, and 5 percent will have alterations of the ALK gene. ALCHEMIST will screen about 6,000 to 8,000 potential participants at hundreds of sites across the United States over five to six years to identify those with EGFR and ALK alterations who would be eligible for the two ALCHEMIST treatment trials. The researchers expect a total enrollment of about 800 patients in those treatment trials. All screened participants, irrespective of the marker status of their tumors, will be followed for five years in the screening trial.

All participants in ALCHEMIST will continue to receive the best care possible for their lung cancer. At the conclusion of the treatment trials, statisticians will analyze the survival of patients who received an additional genetically-targeted drug therapy versus patients who received standard therapy alone.

ALCHEMIST involves substantial collaborations with biotechnology and pharmaceutical partners. For the ALCHEMIST screening component, central laboratory testing for EGFR gene mutations and for the ALK gene rearrangement will be performed by Response Genetics, Inc., Los Angeles. For the ALCHEMIST treatment trials, Pfizer, New York City, will provide crizotinib under a clinical trials agreement with the ECOG-ACRIN Cancer Research Group. Astellas Pharma US, Inc., Northbrook, Illinois, will provide erlotinib under a cooperative research and development agreement with NCI for the clinical development of erlotinib.

“This approach highlights the ability of NCTN to efficiently screen large numbers of patients in order to identify those with early-stage EGFR mutant or ALK rearranged lung cancer," said Monica Bertagnolli, M.D., Dana-Farber Cancer Institute, head of the lead network (Alliance) for ALCHEMIST. "Without this capability, it would be impossible to identify a sufficient number of patients needed to perform clinical trials to determine whether EGFR or ALK inhibitors prolong survival in early-stage lung cancer.”

ALCHEMIST incorporates a number of other aspects of evolving clinical research and medical practice, including DNA sequencing and genomic analysis of tumor tissue, and possible additional genomic analysis at the time of lung cancer recurrence. Moreover, every participant enrolled in ALCHEMIST will also be studied for cancer risk characteristics, and their tumor tissue will be analyzed with advanced sequencing technologies in a research genomics initiative conducted by the NCI Center for Cancer Genomics (CCG). This research will capitalize on the foundation of CCG’s earlier effort, The Cancer Genome Atlas, which is a collaboration with the National Human Genome Research Institute, another component of NIH.

Results from ALCHEMIST may also benefit future lung cancer patients by helping scientists to:

• Screen for molecular features that may predict response to a drug with a given mechanism of action

• Analyze tumor specimens at relapse to define mechanisms of resistance

• Develop a public database that links clinical outcomes with molecular tumor characteristics.

ALCHEMIST is the second precision medicine clinical trial to launch as part of the new NCTN. The first, Lung-MAP, for patients with advanced squamous cell lung cancer, launched in June 2014.

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