First-Ever ‘Basket Study’ of Cancer Mutations Shows Positive Results

A first-of-its-kind “basket study” of responses to Daiichi Sankyo and Genentech’s Zelboraf on a host of cancer mutations is showing positive results, Memorial Sloan Kettering Cancer Center researchers report.

The basket study approach permits the detection of early signals across multiple tumor types simultaneously and explores whether the tumor lineage could influence sensitivity to treatment. The trial results could lead to developing therapies that combine Zelboraf (vemurafenib) with complementary treatments, according to the study published in the Aug. 20 New England Journal of Medicine.

The researchers set up a clinical trial that focuses on responses to Zelboraf based on specific mutations in tumors rather than where the cancer originated. The early Phase 2 study examined 122 patients who suffer from multiple nonmelanoma BRAF V600-mutated cancers.

Patients suffering from lung, colorectal and ovarian cancers and rare diseases, including Erdheim-Chester disease and Langherhand cell histiocytosis, were included in the study. Response rate and median progression-free survival for patients suffering from non-small cell lung cancer was 42 percent and 7.3 months. Response rate for the two rare diseases was 43 percent, while no patients progressed during therapy.

Anecdotal responses were seen in patients suffering anaplastic pleomorphic xanthoastrocytoma, anaplastic thyroid cancer, cholangiocarcinoma, salivary duct cancer, ovarian cancer, clear cell sarcoma and colorectal cancer.

MSK says the basket study is the first in an impending wave of similar studies focused on cancer-related mutations identified through genomic research. The center is analyzing 410 of the most important genes in thousands of patients.

The National Cancer Institute’s MATCH study began enrolling this month, and the American Society of Clinical Oncology’s TAPUR study is expected to begin enrolling by the end of the year,” MSK spokeswoman Emmy Wang tells CTA. Both will look at multiple tumor types, molecular targets and medicines.

Zelboraf received FDA approval in 2011, in tandem with a companion diagnostic, for the treatment of patients with melanoma whose tumors express the BRAF V600E gene mutation. — John Bechtel

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