Eli Lilly has announced positive top-line results from a late-stage study of its targeted therapy Retevmo (selpercatinib) versus the current first-line standard of care in certain non-small cell lung cancer (NSCLC) patients.

The phase 3 LIBRETTO-431 trial has been evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed with or without Merck’s Keytruda (pembrolizumab) as an initial treatment for adults with rearranged during transfection (RET) fusion-positive advanced or metastatic NSCLC.

A pre-specified interim efficacy analysis showed that the study met its primary endpoint, with Lilly’s therapy demonstrating a statistically significant and clinically meaningful improvement in progression-free survival.

As the company outlined, LIBRETTO-431 is the first randomised study to compare the safety and effectiveness of a targeted therapy to a PD-1 inhibitor plus chemotherapy in cancer patients bearing a specific biomarker.

David Hyman, chief medical officer at Loxo@Lilly, said: "The LIBRETTO-431 trial aims to answer an important question about the selection of initial treatment for people with advanced RET fusion-positive NSCLC and these results suggest Retevmo should be considered a first-line standard of care."

An estimated 2.2 million people worldwide are diagnosed with lung cancer each year. NSCLC accounts for up to 85% of all lung cancer diagnoses in the US, of which approximately 50% have actionable biomarkers.

Hyman said: “This clinically meaningful achievement of improved outcomes underscores the importance of timely and comprehensive genomic testing to inform initial treatment decisions for all patients with NSCLC.

"The results of this study provide further confirmation that RET status – like EGFR, ALK, and others in the family of lung cancer oncogenic drivers – should be known prior to initiating therapy.”

He added that the company will be sharing the latest results in more detail with the oncology community.

The readout comes less than two weeks after Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) was approved by the European Commission (EC) as a treatment option for adults with chronic kidney disease.

Jardiance, which is already approved in the EU to treat adults with type 2 diabetes and heart failure, is a once-daily, oral inhibitor of the sodium glucose co-transporter-2 that works by increasing sugar lost in the urine.

The EC’s latest decision on the drug is supported by positive results from the late-stage EMPA-KIDNEY trial, which evaluated the effect of Jardiance on kidney disease progression and cardiovascular mortality risk in 6,609 patients across a wide range of underlying causes.

Reference：
https://www.pmlive.com/pharma_news/eli_lilly_announces_positive_results_for_retevmo_in_phase_3_lung_cancer_study_1495928