Presentation of Phase 1/2 LIBRETTO-001 trial data will highlight safety and efficacy data of Retevmo® (selpercatinib) in the treatment of RET fusion-positive cancers outside of lung and thyroid cancer

Preclinical characterization data will be presented for oral SERD, BCL2 inhibitor, next-generation KRAS-G12C, and RET inhibitors

INDIANAPOLIS, March 10, 2021 /PRNewswire/ -- 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).

Pipeline HighlightsDuring AACR, Loxo Oncology at Lilly 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. LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial. Phase 1 clinical studies of the BCL2 inhibitor and the KRAS-G12C inhibitor are expected to begin in 2021. Loxo Oncology at Lilly plans to file an Investigational New Drug Application (IND) for the next-generation RET inhibitor in 2021.

All posters will be available on-demand on the AACR website at www.aacr.org from April 10 – June 21. Loxo Oncology at Lilly posters can also be viewed at www.loxooncology.com.

A list of the oral and poster presentations, along with viewing details, is highlighted below.

Retevmo (selpercatinib)

Presentation Title: Efficacy and Safety of Selpercatinib in RET Fusion-Positive Cancers Other than Lung or Thyroid CancersAbstract Number: CT011Session Title: Targeted Therapy and Ovarian Cancer Trials Session Type: Clinical Trials Plenary SessionSession Date and Time: Sunday, April 11, 20212:00 PM – 3:45 PM ET

Presentation Title: Safety of selpercatinib for RET-altered advanced solid tumors: a post hoc analysis of LIBRETTO-001Abstract Number: CT160Session Category: Phase II Clinical TrialsSession Title: Phase II Clinical Trials Session Type: E-Poster Session

Alimta (pemetrexed) 

Presentation Title: Pemetrexed and Platinum plus Pembrolizumab in Patients with Metastatic Non-Squamous Non-Small Cell Lung Cancer By Tumor Burden at Baseline: A Post-hoc Efficacy Analysis of KEYNOTE-189 Abstract Number: 442 Session Category: Clinical Research (Excluding Trials) Session Title: Combination ImmunotherapiesSession Type: E-Poster Session

Sintilimab

Presentation Title: ORIENT-3: A randomized, open-label, phase 3 study of sintilimab versus docetaxel in previously treated advanced/metastatic squamous non-small-cell lung cancer (sqNSCLC) Abstract Number: CT041Session Title: Disease-Oriented Innovative Clinical Research and TrialsSession Type: Clinical Trials MinisymposiumSession Date and Time: Monday, April 12, 2021 1:30 PM – 3:15 PM ET

Pipeline

Presentation Title: Preclinical characterization of LY3484356, a novel, potent and orally bioavailable selective estrogen receptor degrader (SERD)Abstract Number: 1236Session Category: Experimental and Molecular TherapeuticsSession Title: Novel Antitumor Agents 

Poster Title: Preclinical characterization of LOXO-338, a novel, oral and selective BCL2 inhibitorAbstract Number: 1258Session Category: Experimental and Molecular TherapeuticsSession Title: Novel Antitumor Agents

Presentation Title: Preclinical characterization of LY3537982, a novel, highly selective and potent KRAS-G12C inhibitorAbstract Number: 1259Session Category: Experimental and Molecular TherapeuticsSession Title: Novel Antitumor Agents

Poster Title: Preclinical characterization of potent and selective next-generation RET inhibitorsAbstract Number: 1464Session Category: Experimental and Molecular TherapeuticsSession Title: Tyrosine Kinase and Phosphatase Inhibitors

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 (