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ASCO conference: Loxo Oncology presents improved early data for cancer drug

Loxo Oncology Inc. released improved early stage data on its experimental cancer drug showing that tumors shrunk in nearly 80% of patients with a rare genetic mutation.

Interim data from the study dubbed Libretto-001, showed the medicine Loxo-292 helped to shrink tumor size in 77% of the 39 evaluable patients who had rearranged-during-transfection, or RET, fusions and mutations — meaning their cancer growth was driven by the abnormal fusion of the RET gene with another gene.

The results presented at the 2018 American Society of Clinical Oncology meeting were an improvement over the initial data the Connecticut-based biopharmaceutical company had released in mid-May.

The data presented at ASCO were based on an April 2 cutoff date, while the earlier results were based on a Jan. 5 cutoff date. The mid-May results had showed 69% of the 32 evaluable patients with RET-fusion positive tumors had significant tumor size reduction after being treated with the medicine.

"The Loxo-292 Phase 1 data are striking," said Alexander Drilon, the presenting author of the study from the Memorial Sloan Kettering Cancer Center in New York. "The activity we reported is impressive and I am thrilled to see this promising efficacy with limited adverse events, especially in this heavily pre-treated patient population of RET fusion cancers, including those with brain metastases, and RET-mutated MTC [medullary thyroid cancer]."

Among the 30 evaluable patients with RET fusion-positive non-small cell lung cancer, 77% saw their tumors shrink. Meanwhile, 78% of the evaluable patients with such thyroid and pancreatic cancers saw a reduction in their tumors with the experimental medicine. Loxo-292 also shrank tumors in 45% of the 22 evaluable patients who had RET-mutated MTC, the company said in the ASCO presentation.

Most of the side effects related to the therapy were mild, Loxo Oncology said, adding that 12 patients' RET fusion-positive cancer had spread to the central nervous system when they enrolled in the study and all remained in the study without seeing a progression in their disease. Three patients with target lesions in the central nervous system saw a shrinkage in their brain tumors.

At the 2017 ASCO meeting, the company reported that its drug larotrectinib shrank tumors in patients whose cancers had a genetic abnormality in the tumor known as tropomyosin receptor kinase, or TRK, fusion, which can contribute to tumor cell growth.

Later in 2017, Loxo Oncology entered into an agreement with German pharmaceutical and life sciences company Bayer AG to develop and market its TRK inhibitors larotrectinib and Loxo-195.

The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on-site and an additional 3,350 abstracts to be published online.