Lilly Announces Positive Results for Selpercatinib (LOXO-292), Demonstrating a 68 Percent Objective Response Rate and Sustained Durability in Heavily Pretreated RET Fusion-Positive Non-Small Cell Lung Cancer
As of the data cut-off date of
"In this large cohort, selpercatinib's response rate, durability, robust CNS activity, and safety show promise. Furthermore, this continues to confirm that RET fusions are clinically targetable alterations, placing them in the company of activating EGFR/ALK/ROS1 alterations. We are encouraged by these data as there is currently an unmet need to provide genomically-tailored therapy to patients with RET fusion-positive NSCLCs," said
Additional Data in Treatment-Naïve RET Fusion-Positive NSCLC Patients
Investigators also presented the results of selpercatinib in treatment-naïve RET fusion-positive NSCLC patients. In this analysis of 34 patients, selpercatinib treatment resulted in an 85 percent ORR (95% CI: 69-95%). Median DOR and PFS were not reached in this treatment-naïve population, as the majority of patients remain in response or progression-free.
"We're seeing the importance of precision medicines, designed for specific patients, grow in oncology," said Anne White, president of Lilly Oncology. "The data from LIBRETTO-001 show that selpercatinib, also known as LOXO-292, represents an important new advance for patients with RET fusion-positive non-small cell lung cancer, emblematic of the kinds of new oncology medicines we hope to continue to bring forward at Lilly Oncology. We're very excited to partner with Loxo Oncology to continue to accelerate this important medicine. In two and half years, Loxo Oncology advanced this molecule from first human dose to submission ready data, demonstrating the power of precision oncology to rapidly translate scientific discovery into treatments for patients."
"When we first started the selpercatinib discovery program, we hoped to build a RET inhibitor that would deliver for patients with RET-altered cancers in the way that medicines such as osimertinib and alectinib have delivered for EGFR-mutated and ALK-fusion patients, respectively. We believe that the selpercatinib data presented at World Lung validate these efforts," said
The LIBRETTO-001 Phase 1/2 trial is the largest clinical trial of patients with RET-altered cancers treated with a RET inhibitor. The trial includes a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2). The Phase 2 portion of the trial had a primary endpoint of objective response rate (ORR) and secondary endpoints of duration of response, progression free survival and safety. The primary analysis set for NSCLC regulatory submissions, as defined with the
About Selpercatinib (LOXO-292)
Selpercatinib, also known as LOXO-292, is a highly selective and potent, oral investigational new medicine in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. Selpercatinib was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms.
Selpercatinib has received breakthrough designation for the treatment of patients with:
- Metastatic RET fusion-positive non-small cell lung cancer who require systemic therapy and have progressed following platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy;
- RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options; and for
- Advanced RET-fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options.
About RET-Altered Cancers
Genomic alterations in RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2 percent of non-small cell lung cancer, 10-20 percent of papillary and other thyroid cancers and a subset of other cancers. Activating RET point mutations account for approximately 60 percent of MTC. RET fusion-positive cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.
About Lilly Oncology
For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. To learn more about Lilly's commitment to people with cancer, please visit www.LillyOncology.com.
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY
Lilly Forward-Looking Statement
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Lilly's oral selpercatinib monotherapy (LOXO-292) for the potential treatment of RET fusion-positive non-small cell lung cancer and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that selpercatinib will receive regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the
 PINN, pending USAN approval
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