INDIANAPOLIS - Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021.

During the meeting, Lilly Oncology will present data from a study exploring safety and efficacy of its selective RET-kinase inhibitor Retevmo (selpercatinib, 40 mg & 80 mg capsules) in patients with rearranged during transfection (RET) fusion-positive cancers outside of lung and thyroid cancer. Additionally, Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company, will present preclinical characterization data for an oral selective estrogen receptor degrader (SERD), BCL2 inhibitor, next-generation KRAS-G12C inhibitor, and next-generation RET inhibitor.

Portfolio Highlights

Last May, Lilly's first-in-class oral precision medicine, Retevmo received Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) in adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and in adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Retevmo was approved under the FDA's Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial's endpoints of overall response rate (ORR) and duration of response (DoR). Given that RET alterations are implicated in the pathogenesis of cancer types other than lung and thyroid cancer, Lilly continues to investigate the potential benefits of treatment with Retevmo in patients with other RET-altered cancers. At AACR, Lilly will feature data evaluating the safety and efficacy of Retevmo in patients with RET fusion-positive cancers other than lung and thyroid cancer. Lilly will present findings from a post-hoc safety analysis of the Phase 1/2 LIBRETTO-001 trial, the largest clinical trial in patients with RET-altered cancers.

Lilly will also present post-hoc efficacy data on Merck's Phase 3 KEYNOTE-189 trial, which evaluated ALIMTA (pemetrexed for injection) in combination with KEYTRUDA (pembrolizumab) and cisplatin or carboplatin compared with ALIMTA in combination with placebo and cisplatin or carboplatin, in untreated patients with metastatic nonsquamous NSCLC, regardless of PD-L1 expression.

Additionally, Lilly will present data on the Phase 3 ORIENT-3 trial, which evaluated sintilimab injection compared with docetaxel in patients with previously treated advanced/metastatic squamous NSCLC (sqNSCLC).

About Retevmo (selpercatinib)

Retevmo (selpercatinib, formerly known as LOXO-292) (pronounced reh-TEHV-moh) is a selective and potent RET kinase inhibitor. Retevmo may affect both tumor cells and healthy cells, which can result in side effects. RET-driver alterations are predominantly mutually exclusive from other oncogenic drivers. Retevmo is an U.S. FDA-approved oral prescription medicine, 120 mg or 160 mg dependent on weight (

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